ISSN 1725-2555

doi:10.3000/17252555.L_2009.342.eng

Official Journal

of the European Union

L 342

European flag  

English edition

Legislation

Volume 52
22 December 2009


Contents

 

I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory

page

 

 

REGULATIONS

 

*

Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS), repealing Regulation (EC) No 761/2001 and Commission Decisions 2001/681/EC and 2006/193/EC

1

 

*

Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters ( 1 )

46

 

*

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products ( 1 )

59

 


 

(1)   Text with EEA relevance

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.


I Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory

REGULATIONS

22.12.2009   

EN

Official Journal of the European Union

L 342/1


REGULATION (EC) No 1221/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 25 November 2009

on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS), repealing Regulation (EC) No 761/2001 and Commission Decisions 2001/681/EC and 2006/193/EC

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

(1)

Article 2 of the Treaty provides that the Community is to have among its tasks the promotion of sustainable growth throughout the Community.

(2)

Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme (4) identifies the improvement of collaboration and partnership with enterprises as a strategic approach to meeting environmental objectives. Voluntary commitments are an essential part thereof. Encouraging wider participation in the Community's eco-management and audit scheme (EMAS) and the development of initiatives to encourage organisations to publish rigorous and independently verified environmental or sustainable development performance reports is regarded as necessary in this context.

(3)

The Commission Communication of 30 April 2007 on the Mid-term review of the Sixth Community Environment Action Programme recognises that there is a need to improve the functioning of the voluntary instruments that have been designed for industry and that those instruments have a great potential but have not been fully developed. It calls upon the Commission to revise the instruments in order to promote their participation and reduce the administrative burden in their management.

(4)

The Commission Communication of 16 July 2008 on the Sustainable Consumption and Production and Sustainable Industrial Policy Action Plan recognises that EMAS helps organisations to optimise their production processes, reducing environmental impacts and making more effective use of resources.

(5)

For the purpose of promoting a coherent approach between the legislative instruments developed at Community level in the field of environmental protection, the Commission and the Member States should consider how registration under EMAS may be taken into account in the development of legislation or used as a tool in the enforcement of legislation. They should also, in order to raise the appeal of EMAS for organisations, take account of EMAS in their procurement policies and, where appropriate, refer to EMAS or equivalent environmental management systems as contract performance conditions for works and service.

(6)

Article 15 of Regulation (EC) No 761/2001 of the European Parliament and of the Council of 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (5) provides that the Commission is to review EMAS in the light of the experience gained during its operation and propose appropriate amendments to the European Parliament and the Council.

(7)

Application of environmental management schemes, including EMAS as set out in Regulation (EC) No 761/2001, demonstrated their effectiveness in promoting improvements of the environmental performance of organisations. There is, however, a need to increase the number of organisations participating in the scheme in order to achieve a better overall impact of environmental improvements. To this effect, the experience gathered from the implementation of that Regulation should be used to enhance the ability of EMAS to bring about an improvement in the overall environmental performance of organisations.

(8)

Organisations should be encouraged to participate in EMAS on a voluntary basis and may gain added value in terms of regulatory control, cost savings and public image provided that they are able to demonstrate an improvement of their environmental performance.

(9)

EMAS should be made available to all organisations, in and outside the Community, whose activities have an environmental impact. EMAS should provide a means for those organisations to manage that impact and to improve their overall environmental performance.

(10)

Organisations, in particular small organisations, should be encouraged to participate in EMAS. Their participation should be promoted by facilitating access to information, to existing support funds and to public institutions and by establishing or promoting technical assistance measures.

(11)

Organisations which implement other environmental management systems and want to move to EMAS should be able to do so as easily as possible. Links with other environmental management schemes should be considered.

(12)

Organisations with sites located in one or more Member States should be able to register all or a number of those sites under one single registration.

(13)

The mechanism for establishing an organisation's compliance with all applicable legal requirements relating to the environment should be strengthened in order to enhance the credibility of EMAS and, in particular, to enable Member States to reduce the administrative burden of registered organisations by way of deregulation or regulatory relief.

(14)

The process of implementation of EMAS should include involvement of employees and workers of the organisation as this increases job satisfaction, as well as knowledge of environmental issues which can be replicated in and outside the work environment.

(15)

The EMAS logo should be an appealing communication and marketing tool for organisations, which raises the awareness of buyers and other stakeholders to EMAS. Rules for the use of the EMAS logo should be simplified by the use of one single logo and existing restrictions should be removed save for those relating to the product and packaging. There should be no confusion with environmental product labels.

(16)

Costs and fees for registration under EMAS should be reasonable and proportionate to the size of the organisation and the work to be done by the Competent Bodies. Without prejudice to the rules of the Treaty on State aid, exemptions or reductions of fees should be considered for small organisations.

(17)

Organisations should produce and make publicly available periodic environmental statements providing the public and other interested parties with information on their compliance with applicable legal requirements relating to the environment and their environmental performance.

(18)

In order to ensure relevance and comparability of the information, reporting on the organisations’ environmental performance should be on the basis of generic and sector-specific performance indicators focusing on key environmental areas at the process and product level using appropriate benchmarks and scales. This should help organisations compare their environmental performance both over different reporting periods and with the environmental performance of other organisations.

(19)

Reference documents including best environmental management practice and environmental performance indicators for specific sectors should be developed through information exchange and collaboration between Member States. Those documents should help organisations better focus on the most important environmental aspects in a given sector.

(20)

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (6) organises accreditation at the national and European levels and sets the overall framework for accreditation. This Regulation should complement those rules in so far as necessary, while taking into account the specific features of EMAS such as the need to ensure a high level of credibility towards stakeholders, especially Member States and, where appropriate, should set more specific rules. The EMAS provisions should ensure and steadily improve the competence of environmental verifiers by providing for an independent and neutral accreditation or licensing system, training and an appropriate supervision of their activities and thus guarantee the transparency and credibility of organisations participating in EMAS.

(21)

When a Member State decides not to use accreditation for EMAS, Article 5(2) of Regulation (EC) No 765/2008 should apply.

(22)

Promotion and support activities should be undertaken by both the Member States and the Commission.

(23)

Without prejudice to the rules of the Treaty on State aid, incentives should be given by Member States to registered organisations such as access to funding or tax incentives in the framework of schemes supporting environmental performance of industry, provided that organisations are able to demonstrate an improvement of their environmental performance.

(24)

Member States and the Commission should develop and implement specific measures aimed at greater participation in EMAS by organisations, in particular small organisations.

(25)

With the aim of ensuring a harmonised application of this Regulation, the Commission should produce sectoral reference documents in the area covered by this Regulation following a priority programme.

(26)

This Regulation should be revised, if appropriate, within five years of its entry into force in the light of experience gained.

(27)

This Regulation replaces Regulation (EC) No 761/2001 which should therefore be repealed.

(28)

Given that useful elements of Commission Recommendation 2001/680/EC of 7 September 2001 on guidance for the implementation of Regulation (EC) No 761/2001 of the European Parliament and of the Council allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (7) and of Commission Recommendation 2003/532/EC of 10 July 2003 on guidance for the implementation of Regulation (EC) No 761/2001 of the European Parliament and of the Council allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) concerning the selection and use of environmental performance indicators (8) are included in this Regulation, those acts should no longer be used as they are superseded by this Regulation.

(29)

Since the objectives of this Regulation, namely to create a single credible scheme and avoid the establishment of different national schemes, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(30)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9).

(31)

In particular the Commission should be empowered to establish procedures for the peer evaluation of Competent Bodies, to develop sectoral reference documents, to recognise existing environmental management systems, or parts thereof, as complying with corresponding requirements of this Regulation and to amend Annexes I to VIII. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(32)

Since a period of time is required to ensure that the framework for the proper functioning of this Regulation is in place, Member States should have a period of 12 months following the date of entry into force of this Regulation to modify the procedures followed by Accreditation Bodies and Competent Bodies under the corresponding provisions of this Regulation. Within that 12-month period, Accreditation Bodies and Competent Bodies should be entitled to continue to apply the procedures established under Regulation (EC) No 761/2001,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Objective

A Community eco-management and audit scheme, hereinafter referred to as ‘EMAS’, is hereby established, allowing voluntary participation by organisations located inside or outside the Community.

The objective of EMAS, as an important instrument of the Sustainable Consumption and Production and Sustainable Industrial Policy Action Plan, is to promote continuous improvements in the environmental performance of organisations by the establishment and implementation of environmental management systems by organisations, the systematic, objective and periodic evaluation of the performance of such systems, the provision of information on environmental performance, an open dialogue with the public and other interested parties and the active involvement of employees in organisations and appropriate training.

Article 2

Definitions

For the purposes of this Regulation the following definitions shall apply:

1.

‘environmental policy’ means the overall intentions and direction of an organisation relating to its environmental performance as formally expressed by top management including compliance with all applicable legal requirements relating to the environment and also a commitment to continuous improvement of environmental performance. It provides a framework for action and for the setting of environmental objectives and targets;

2.

‘environmental performance’ means the measurable results of an organisation's management of its environmental aspects;

3.

‘legal compliance’ means full implementation of applicable legal requirements, including permit conditions, relating to the environment;

4.

‘environmental aspect’ means an element of an organisation's activities, products or services that has or can have an impact on the environment;

5.

‘significant environmental aspect’ means an environmental aspect that has or can have a significant environmental impact;

6.

‘direct environmental aspect’ means an environmental aspect associated with activities, products and services of the organisation itself over which it has direct management control;

7.

‘indirect environmental aspect’ means an environmental aspect which can result from the interaction of an organisation with third parties and which can to a reasonable degree be influenced by an organisation;

8.

‘environmental impact’ means any change to the environment, whether adverse or beneficial, wholly or partially resulting from an organisation's activities, products or services;

9.

‘environmental review’ means an initial comprehensive analysis of environmental aspects, environmental impacts and environmental performance related to an organisation's activities, products and services;

10.

‘environmental programme’ means a description of the measures, responsibilities and means taken or envisaged to achieve environmental objectives and targets and the deadlines for achieving the environmental objectives and targets;

11.

‘environmental objective’ means an overall environmental goal, arising from the environmental policy, that an organisation sets itself to achieve, and which is quantified where practicable;

12.

‘environmental target’ means a detailed performance requirement, arising from the environmental objectives, applicable to an organisation or parts thereof, and that needs to be set and met in order to achieve those objectives;

13.

‘environmental management system’ means the part of the overall management system that includes the organisational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy and managing the environmental aspects;

14.

‘best environmental management practice’ means the most effective way to implement the environmental management system by organisations in a relevant sector and that can result in best environmental performance under given economic and technical conditions;

15.

‘substantial change’ means any change in an organisation's operation, structure, administration, processes, activities, products or services that has or can have a significant impact on an organisation's environmental management system, the environment or human health;

16.

‘internal environmental audit’ means a systematic, documented, periodic and objective evaluation of the environmental performance of an organisation, management system and processes designed to protect the environment;

17.

‘auditor’ means an individual or group of individuals, belonging to an organisation itself or a natural or legal person external to that organisation, acting on behalf of that organisation, carrying out an assessment of, in particular, the environmental management system in place and determining conformity with the organisation's environmental policy and programme, including compliance with the applicable legal requirements relating to the environment;

18.

‘environmental statement’ means the comprehensive information to the public and other interested parties regarding an organisation's:

(a)

structure and activities;

(b)

environmental policy and environmental management system;

(c)

environmental aspects and impacts;

(d)

environmental programme, objectives and targets;

(e)

environmental performance and compliance with applicable legal obligations relating to the environment as set out in Annex IV;

19.

‘updated environmental statement’ means the comprehensive information to the public and other interested parties containing updates of the last validated environmental statement, only with regard to an organisation's environmental performance and compliance with applicable legal obligations relating to the environment as set out in Annex IV;

20.

‘environmental verifier’ means:

(a)

a conformity assessment body as defined in Regulation (EC) No 765/2008 or any association or group of such bodies, which has obtained accreditation in accordance with this Regulation; or

(b)

any natural or legal person, or any association or group of such persons, which has obtained a licence to carry out verification and validation in accordance with this Regulation;

21.

‘organisation’ means a company, corporation, firm, enterprise, authority or institution, located inside or outside the Community, or part or combination thereof, whether incorporated or not, public or private, which has its own functions and administration;

22.

‘site’ means a distinct geographic location under the management control of an organisation covering activities, products and services, including all infrastructure, equipment and materials; a site is the smallest entity to be considered for registration;

23.

‘cluster’ means a group of independent organisations related to each other by geographical proximity or business activities jointly implementing the environmental management system;

24.

‘verification’ means the conformity assessment process carried out by an environmental verifier to demonstrate whether an organisation's environmental review, environmental policy, environmental management system and internal environmental audit and its implementation fulfils the requirements of this Regulation;

25.

‘validation’ means the confirmation by the environmental verifier who carried out the verification, that the information and data in an organisation's environmental statement and updated environmental statement are reliable, credible and correct and meet the requirements of this Regulation;

26.

‘enforcement authorities’ means the relevant competent authorities as identified by the Member States to detect, prevent and investigate breaches of applicable legal requirements relating to the environment and, where required, take enforcement action;

27.

‘environmental performance indicator’ means a specific expression that allows measurement of an organisation's environmental performance;

28.

‘small organisations’ means:

(a)

micro, small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (10); or

(b)

local authorities governing less than 10 000 inhabitants or other public authorities employing fewer than 250 persons and having an annual budget not exceeding EUR 50 million, or an annual balance sheet not exceeding EUR 43 million, including all of the following:

(i)

government or other public administrations, or public advisory bodies at national, regional or local level;

(ii)

natural or legal persons performing public administrative functions under national law, including specific duties, activities or services in relation to the environment; and

(iii)

natural or legal persons having public responsibilities or functions, or providing public services, relating to the environment under the control of a body or person referred to in point (b);

29.

‘corporate registration’ means a single registration of all or some sites of an organisation with sites located in one or more Member States or third countries;

30.

‘Accreditation Body’ means a national accreditation body appointed pursuant to Article 4 of Regulation (EC) No 765/2008 which is responsible for the accreditation and supervision of environmental verifiers;

31.

‘Licensing Body’ means a body appointed in accordance with Article 5(2) of Regulation (EC) No 765/2008 which is responsible for issuing licences to, and for supervising, environmental verifiers.

CHAPTER II

REGISTRATION OF ORGANISATIONS

Article 3

Determination of the Competent Body

1.   Applications for registration from organisations in a Member State shall be made to a Competent Body in that Member State.

2.   An organisation with sites located in one or more Member States or third countries may apply for one single corporate registration of all or some of those sites.

Applications for a single corporate registration shall be made to a Competent Body of the Member State where the organisation's headquarters or management centre designated for the purpose of this paragraph is located.

3.   Applications for registration from organisations outside the Community, including corporate registration consisting only of sites located outside the Community, shall be made to any Competent Body in those Member States that provide for the registration of organisations from outside the Community in accordance with the second subparagraph of Article 11(1).

Those organisations shall ensure that the environmental verifier which will carry out the verification and validate the environmental management system of the organisation is accredited or licensed in the Member State where the organisation applies for registration.

Article 4

Preparation for registration

1.   Organisations wishing to be registered for the first time shall:

(a)

carry out an environmental review of all environmental aspects of the organisation in accordance with the requirements set out in Annex I and in point A.3.1 of Annex II;

(b)

in the light of the results of the environmental review, develop and implement an environmental management system covering all the requirements referred to in Annex II, and, where available, taking into account the best environmental management practice for the relevant sector referred to in Article 46(1)(a);

(c)

carry out an internal audit in accordance with the requirements set out in point A.5.5 of Annex II and Annex III;

(d)

prepare an environmental statement, in accordance with Annex IV. Where sectoral reference documents as referred to in Article 46 are available for the specific sector, the assessment of the organisation's environmental performance shall take into account the relevant document.

2.   Organisations may use the assistance referred to in Article 32 that is available in the Member State where the organisation applies for registration.

3.   Organisations which have a certified environmental management system, recognised in accordance with Article 45(4), shall not be obliged to carry out those parts which have been recognised as equivalent to this Regulation.

4.   Organisations shall provide material or documentary evidence showing that the organisation complies with all applicable legal requirements relating to the environment.

Organisations may request information from the competent enforcement authority or authorities in accordance with Article 32 or the environmental verifier.

Organisations outside the Community shall also make reference to the legal requirements relating to the environment applicable to similar organisations in the Member States where they intend to submit an application.

Where sectoral reference documents as referred to in Article 46 are available for the specific sector, the assessment of the organisation's environmental performance shall be made with reference to the relevant document.

5.   The initial environmental review, the environment management system, the audit procedure and its implementation shall be verified by an accredited or licensed environmental verifier and the environmental statement shall be validated by that verifier.

Article 5

Application for registration

1.   Any organisation meeting requirements set out in Article 4 may apply for registration.

2.   The application for registration shall be made to the Competent Body determined in accordance with Article 3 and shall include the following:

(a)

the validated environmental statement in electronic or printed form;

(b)

the declaration as referred to in Article 25(9), signed by the environmental verifier which validated the environmental statement;

(c)

a completed form, which includes at least the minimum information on as set out in Annex VI;

(d)

evidence of payment of applicable fees, if applicable.

3.   The application shall be written in (one of) the official language(s) of the Member State in which the organisation applies for registration.

CHAPTER III

OBLIGATIONS OF REGISTERED ORGANISATIONS

Article 6

Renewal of EMAS registration

1.   A registered organisation shall at least on a three-yearly basis:

(a)

have the full environmental management system and audit programme and its implementation verified;

(b)

prepare the environmental statement in accordance with the requirements set out in Annex IV and have it validated by an environmental verifier;

(c)

forward the validated environmental statement to the Competent Body;

(d)

forward to the Competent Body a completed form, which includes at least the minimum information set out in Annex VI;

(e)

pay a fee for the renewal of the registration to the Competent Body, if applicable.

2.   Without prejudice to paragraph 1, in the intervening years, a registered organisation shall:

(a)

in accordance with the audit programme, carry out an internal audit of its environmental performance and compliance with applicable legal requirements relating to the environment in accordance with Annex III;

(b)

prepare an updated environmental statement in accordance with the requirements laid down in Annex IV, and have it validated by an environmental verifier;

(c)

forward the validated updated environmental statement to the Competent Body;

(d)

forward to the Competent Body a completed form, which includes at least the minimum information set out in Annex VI;

(e)

pay a fee for the maintenance of the registration to the Competent Body, if applicable.

3.   Registered organisations shall make their environmental statement and updated environmental statement accessible to the public within one month of registration and one month after the renewal of the registration is completed.

Registered organisations may satisfy that requirement by providing access to the environmental statement and the updated environmental statement upon request or by creating links to Internet sites where those statements can be accessed.

Registered organisations shall specify the way in which they provide public access in the form set out in Annex VI.

Article 7

Derogation for small organisations

1.   Competent Bodies shall, upon request of a small organisation, extend for that organisation the three-yearly frequency referred to in Article 6(1) up to four years or the annual frequency referred to in Article 6(2) up to two years, provided that the environmental verifier that has verified the organisation confirms that all the following conditions are met:

(a)

no significant environmental risks are present;

(b)

the organisation has no substantial changes planned as defined in Article 8, and

(c)

there exist no significant local environmental problems that the organisation contributes to.

To submit the request referred to in the first subparagraph, the organisation may use the form set out in Annex VI.

2.   The Competent Body shall refuse the request if the conditions set out in paragraph 1 are not met. It shall communicate a reasoned justification to the organisation.

3.   Organisations benefiting from an extension of up to two years, as referred to in paragraph 1, shall forward the non-validated updated environmental statement to the Competent Body each year that they are exempt from the obligation to have a validated updated environmental statement.

Article 8

Substantial changes

1.   Where a registered organisation plans to introduce substantial changes, the organisation shall carry out an environmental review of these changes, including their environmental aspects and impacts.

2.   Following the environmental review of changes, the organisation shall update the initial environmental review, modify the environmental policy, the environmental programme and the environmental management system and revise and update the entire environmental statement accordingly.

3.   All documents modified and updated pursuant to paragraph 2 shall be verified and validated within six months.

4.   After validation, the organisation shall submit changes to the Competent Body using the form set out in Annex VI and make the changes publicly available.

Article 9

Internal environmental audit

1.   A registered organisation shall establish an audit programme that ensures that over a period of time, not exceeding three years or four years if the derogation provided for in Article 7 applies, all activities in the organisation are subject to an internal environmental audit in accordance with the requirements set out in Annex III.

2.   The audit shall be carried out by auditors who possess, individually or collectively, the competence necessary for carrying out these tasks and are sufficiently independent of the activities they audit to make an objective judgment.

3.   The organisation's environmental auditing programme shall define the objectives of each audit or audit cycle including the audit frequency for each activity.

4.   A written audit report shall be prepared by the auditors at the end of each audit and audit cycle.

5.   The auditor shall communicate the findings and conclusions of the audit to the organisation.

6.   Following the audit process, the organisation shall prepare and implement an appropriate action plan.

7.   The organisation shall put in place appropriate mechanisms that ensure that the audit results are followed up.

Article 10

Use of the EMAS logo

1.   Without prejudice to Article 35(2), the EMAS logo set out in Annex V may be used only by registered organisations and only as long as their registration is valid.

The logo shall always bear the registration number of the organisation.

2.   The EMAS logo shall only be used in accordance with the technical specifications set out in Annex V.

3.   In case an organisation chooses, in accordance with Article 3(2), not to include all its sites in the corporate registration, it shall ensure that in its communications with the public and in its use of the EMAS logo it is clear which sites are covered by the registration.

4.   The EMAS logo shall not be used:

(a)

on products or their packaging; or

(b)

in conjunction with comparative claims concerning other activities and services or in a way that may create confusion with environmental product labels.

5.   Any environmental information published by a registered organisation may bear the EMAS logo provided such information makes reference to the organisation's latest environmental statement or updated environmental statement from which it was drawn and it has been validated by an environmental verifier as being:

(a)

accurate;

(b)

substantiated and verifiable;

(c)

relevant and used in an appropriate context or setting;

(d)

representative of the overall environmental performance of the organisation;

(e)

unlikely to result in misinterpretation; and

(f)

significant in relation to the overall environmental impact.

CHAPTER IV

RULES APPLICABLE TO COMPETENT BODIES

Article 11

Designation and role of Competent Bodies

1.   Member States shall designate Competent Bodies, which shall be responsible for the registration of organisations located in the Community in accordance with this Regulation.

Member States may provide that the Competent Bodies they designate provide for and shall be responsible for the registration of organisations located outside the Community in accordance with this Regulation.

The Competent Bodies shall control the entry and maintenance of organisations on the register, including suspension and deletion.

2.   The Competent Bodies may be national, regional or local.

3.   The composition of the Competent Bodies shall guarantee their independence and neutrality.

4.   The Competent Bodies shall have the appropriate resources, both financial and in terms of personnel, for the proper performance of their tasks.

5.   The Competent Bodies shall apply this Regulation in a consistent manner and shall participate in regular peer evaluation as set out in Article 17.

Article 12

Obligations concerning the registration process

1.   Competent Bodies shall establish procedures for the registration of organisations. They shall in particular establish rules for:

(a)

considering observations from interested parties, including Accreditation and Licensing Bodies and competent enforcement authorities and the organisations’ representative bodies, concerning applicant or registered organisations;

(b)

refusal of registration, suspension or deletion of organisations, and

(c)

resolution of appeals and complaints made against their decisions.

2.   Competent Bodies shall establish and maintain a register of organisations registered in their Member States, including information as to how their environmental statement or updated environmental statement can be obtained, and, in the case of changes, update that register on a monthly basis.

The register shall be publicly available on a website.

3.   Competent Bodies shall each month, directly or via the national authorities as decided by the Member States concerned, communicate changes in the register referred to in paragraph 2 to the Commission.

Article 13

Registration of organisations

1.   Competent Bodies shall consider applications for registration of organisations in accordance with the procedures established to this end.

2.   Where an organisation applies for registration, the Competent Body shall register that organisation and give it a registration number if all the following conditions are fulfilled:

(a)

the Competent Body has received an application for registration, which includes all the documents referred to in Article 5(2)(a) to (d);

(b)

the Competent Body has checked that the verification and validation have been carried out in accordance with Articles 25, 26 and 27;

(c)

the Competent Body is satisfied on the basis of material evidence received, for example through a written report from the competent enforcement authority that there is no evidence of breach of applicable legal requirements relating to the environment;

(d)

there are no relevant complaints from interested parties or complaints have been positively solved;

(e)

the Competent Body is satisfied on the basis of evidence received that the organisation meets all the requirements of this Regulation; and

(f)

the Competent Body has received a registration fee, if applicable.

3.   The Competent Body shall inform the organisation that it has been registered and provide the organisation with its registration number and the EMAS logo.

4.   If a Competent Body concludes that an applicant organisation does not comply with the requirements set out in paragraph 2, it shall refuse to register that organisation and communicate a reasoned justification to the organisation.

5.   If a Competent Body receives a written supervision report from the Accreditation or Licensing Body which provides evidence that the activities of the environmental verifier were not performed adequately enough to ensure that the requirements of this Regulation are met by the applicant organisation, it shall refuse to register that organisation. The Competent Body shall invite the organisation to submit a new application for registration.

6.   In order to obtain the necessary evidence for taking a decision on refusal of registration of organisations, the Competent Body shall consult the concerned parties including the organisation.

Article 14

Renewal of the organisation's registration

1.   A Competent Body shall renew the registration of the organisation if all the following conditions are fulfilled:

(a)

the Competent Body has received a validated environmental statement as referred to in Article 6(1)(c), a validated updated environmental statement as referred to in Article 6(2)(c) or a non-validated updated environmental statement as referred to in Article 7(3);

(b)

the Competent Body has received a completed form, which includes at least the minimum information set out in Annex VI, as referred to in Article 6(1)(d) and in Article 6(2)(d);

(c)

the Competent Body has no evidence that the verification and validation have not been carried out in accordance with Articles 25, 26 and 27;

(d)

the Competent Body has no evidence of non-compliance by the organisation with applicable legal requirements relating to the environment;

(e)

there are no relevant complaints from interested parties or complaints have been positively solved;

(f)

the Competent Body is satisfied on the basis of evidence received that the organisation meets all the requirements of this Regulation; and

(g)

the Competent Body has received a fee for renewal of the registration, if applicable.

2.   The Competent Body shall inform the organisation that its registration has been renewed.

Article 15

Suspension or deletion of organisations from the register

1.   Where a Competent Body believes that a registered organisation does not comply with this Regulation, it shall give the organisation the opportunity to submit its views on the matter. Should the organisation fail to provide a satisfactory response it shall be deleted or suspended from the register.

2.   Where a Competent Body receives a written supervision report from the Accreditation or Licensing Body which provides evidence that the activities of the environmental verifier were not performed adequately enough to ensure that the requirements of this Regulation are met by the registered organisation, registration shall be suspended.

3.   A registered organisation shall be suspended or deleted from the register, as appropriate, if it fails to submit to a Competent Body, within two months of being required to do so, any of the following:

(a)

the validated environmental statement, an updated environmental statement or the signed declaration referred to in Article 25(9);

(b)

a form which includes at least the minimum information set out in Annex VI from the organisation.

4.   If a Competent Body is informed through a written report by the competent enforcement authority of a breach by the organisation of any applicable legal requirements relating to the environment, it shall suspend or delete the reference to that organisation from the register as appropriate.

5.   In case a Competent Body decides to suspend or delete a registration it shall take into account at least the following:

(a)

the environmental effect of the non-compliance by the organisation with the requirements of this Regulation;

(b)

the foreseeability of the non-compliance by the organisation with the requirements of this Regulation or the circumstances leading to it;

(c)

previous instances of non-compliance with the requirements of this Regulation by the organisation; and

(d)

the specific circumstances of the organisation.

6.   In order to obtain the necessary evidence for taking its decision on suspension or deletion of organisations from the register, the Competent Body shall consult the concerned parties including the organisation.

7.   Where the Competent Body has received evidence, other than by means of a written supervision report of the Accreditation or Licensing Body, that activities of the environmental verifier were not performed adequately enough to ensure that the requirements of this Regulation are met by the organisation, it shall consult the Accreditation or Licensing Body supervising the environmental verifier.

8.   The Competent Body shall give reasons for any measures taken.

9.   The Competent Body shall provide appropriate information to the organisation concerning the consultations with the concerned parties.

10.   Suspension of an organisation from the register shall be lifted if the Competent Body has received satisfactory information that the organisation is in compliance with the requirements of this Regulation.

Article 16

Forum of Competent Bodies

1.   A Forum of Competent Bodies from all Member States, hereinafter referred to as ‘the Forum of Competent Bodies’, shall be set up by the Competent Bodies and meet at least once per year in the presence of a representative of the Commission.

The Forum of Competent Bodies shall adopt its rules of procedure.

2.   Competent Bodies of each Member State shall participate in the Forum of Competent Bodies. Where several Competent Bodies are established within one Member State, appropriate measures shall be taken to ensure that all of them are informed about the activities of the Forum of Competent Bodies.

3.   The Forum of Competent Bodies shall develop guidance to ensure the consistency of procedures relating to the registration of organisations in accordance with this Regulation, including renewal of registration and suspension and deletion of organisations from the register both inside and outside the Community.

The Forum of Competent Bodies shall transmit to the Commission the guidance documents and documents referring to the peer evaluation.

4.   Guidance documents referring to harmonisation procedures approved by the Forum of Competent Bodies shall be proposed as appropriate by the Commission for adoption in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).

Those documents shall be made publicly available.

Article 17

Peer evaluation of Competent Bodies

1.   A peer evaluation shall be organised by the Forum of Competent Bodies to assess conformity of the registration system of every Competent Body with this Regulation and to develop a harmonised approach to the application of the rules relating to registration.

2.   The peer evaluation shall be carried out on a regular basis and at least every four years, and shall include an assessment of the rules and procedures set out in Articles 12, 13 and 15. All Competent Bodies shall participate in the peer evaluation.

3.   The Commission shall establish procedures for carrying out the peer evaluation, including appropriate appeals procedures against decisions taken as a result of the peer evaluation.

Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).

4.   Procedures referred to in paragraph 3 shall be established before the first peer evaluation takes place.

5.   The Forum of Competent Bodies shall transmit a regular report of the peer evaluation to the Commission and the Committee established under Article 49(1).

That report shall be made publicly available after approval by the Forum of Competent Bodies and the Committee referred to in the first subparagraph.

CHAPTER V

ENVIRONMENTAL VERIFIERS

Article 18

Tasks of Environmental verifiers

1.   Environmental verifiers shall assess whether an organisation's environmental review, environmental policy, management system, audit procedures and their implementation comply with the requirements of this Regulation.

2.   Environmental verifiers shall verify the following:

(a)

compliance of the organisation with all the requirements of this Regulation with respect to the initial environmental review, environmental management system, environmental audit and its results and the environmental statement or updated environmental statement;

(b)

compliance of the organisation with applicable Community, national, regional and local legal requirements relating to the environment;

(c)

the organisation's continuous improvement of environmental performance; and

(d)

the reliability, credibility and correctness of the data and information in the following documents:

(i)

the environmental statement;

(ii)

the updated environmental statement;

(iii)

any environmental information to be validated.

3.   Environmental verifiers shall, in particular, verify the appropriateness of the initial environmental review, or audit or other procedures carried out by the organisation, without unnecessarily duplicating those procedures.

4.   Environmental verifiers shall verify whether the results of the internal audit are reliable. Where appropriate, they shall use spot-checks for that purpose.

5.   At the time of the verification for the preparation for registration of an organisation, the environmental verifier shall check that at least the following requirements are met by that organisation:

(a)

a fully operational environmental management system in accordance with Annex II is in place;

(b)

a fully planned audit programme is in place and has begun in accordance with Annex III so that at least the most significant environmental impacts have been covered;

(c)

the management review referred to in Part A of Annex II is completed; and

(d)

an environmental statement is prepared in accordance with Annex IV and sectoral reference documents were taken into account, where available.

6.   For the purposes of the verification for the renewal of registration referred to in Article 6(1), the environmental verifier shall check that the following requirements are met by the organisation:

(a)

the organisation has a fully operational environmental management system in accordance with Annex II;

(b)

the organisation has a fully operational planned audit programme, with at least one audit cycle completed in accordance with Annex III;

(c)

the organisation has completed one management review; and

(d)

the organisation has prepared an environmental statement in accordance with Annex IV and sectoral reference documents were taken into account, where available.

7.   For the purposes of the verification for renewal of registration referred to in Article 6(2), the environmental verifier shall check that at least the following requirements are met by the organisation:

(a)

the organisation has carried out an internal audit of the environmental performance and the compliance with applicable legal requirements relating to the environment in accordance with Annex III;

(b)

the organisation demonstrates ongoing compliance with applicable legal requirements relating to the environment and continuous improvement of its environmental performance; and

(c)

the organisation has prepared an updated environmental statement in accordance with Annex IV and, where available, sectoral reference documents were taken into account.

Article 19

Frequency of verification

1.   The environmental verifier shall design, in consultation with the organisation, a programme that ensures that all elements required for registration and renewal of registration referred to in Articles 4, 5 and 6 are verified.

2.   The environmental verifier shall at intervals not exceeding 12 months validate any updated information in the environmental statement or updated environmental statement.

Where relevant, the derogation provided for in Article 7 shall apply.

Article 20

Requirements for environmental verifiers

1.   In order to obtain accreditation or a licence in accordance with this Regulation, a candidate environmental verifier shall introduce a request with the Accreditation or Licensing Body from which it seeks accreditation or a licence.

That request shall specify the scope of the requested accreditation or licence by reference to the classification of economic activities as set out in Regulation (EC) No 1893/2006 (11).

2.   The environmental verifier shall provide to the Accreditation or Licensing Body appropriate evidence of its competence, including knowledge, relevant experience and technical capacities relevant to the scope of the requested accreditation or licence in the following fields:

(a)

this Regulation;

(b)

the general functioning of environmental management systems;

(c)

relevant sectoral reference documents issued by the Commission, under Article 46, for the application of this Regulation;

(d)

the legislative, regulatory and administrative requirements relevant to the activity subject to verification and validation;

(e)

environmental aspects and impacts including the environmental dimension of sustainable development;

(f)

the technical aspects, relevant to environmental issues, of the activity subject to verification and validation;

(g)

the general functioning of the activity subject to verification and validation in order to assess the appropriateness of the management system, in relation to the interaction of the organisation and its products, services and operations with the environment including at least the following:

(i)

technologies employed by the organisation;

(ii)

terminology and tools deployed in the activities;

(iii)

operational activities and characteristics of their interaction with the environment;

(iv)

methodologies for the evaluation of significant environmental aspects;

(v)

pollution control and mitigation technologies;

(h)

environmental auditing requirements and methodology including the ability to undertake effective verification audits of an environmental management system, identification of appropriate audit findings and conclusions and preparation and presentation of audits reports, in oral and written forms, to provide a clear record of the verification audit;

(i)

information audit, the environmental statement and the updated environmental statement in relation to data management, data storage and manipulation, presentation of data in written and graphical format for the appreciation of potential data errors, use of assumptions and estimates;

(j)

the environmental dimension of products and services including the environmental aspects and environmental performance during the usage and post-use, and the integrity of data provided for environmental decision making.

3.   The environmental verifier shall be required to demonstrate a continuing professional development in the fields of competence set out in paragraph 2 and to maintain such development for assessment by the Accreditation or Licensing Body.

4.   The environmental verifier shall be an external third party, independent, in particular of the organisation's auditor or consultant, impartial and objective in performing its activities.

5.   The environmental verifier shall ensure that it is free from any commercial, financial or other pressures which might influence its judgment or endanger trust in its independence of judgment and integrity in relation to the verification activities. The environmental verifier shall ensure compliance with any rules applicable in this respect.

6.   The environmental verifier shall have documented methods and procedures, including quality control mechanisms and confidentiality provisions, to comply with the verification and validation requirements of this Regulation.

7.   Where an organisation acts as environmental verifier, it shall keep an organisation chart detailing structures and responsibilities within the organisation and a statement of legal status, ownership and funding sources.

That organisation chart shall be made available on request.

8.   Compliance with these requirements shall be ensured through the assessment carried out prior to the accreditation or licensing and through the supervision by the Accreditation or Licensing Body.

Article 21

Additional requirements for environmental verifiers which are natural persons and performing verification and validation activities individually

Natural persons acting as environmental verifiers and performing verification and validation individually shall have, in addition to complying with the requirements set out in Article 20:

(a)

all the necessary competence to perform verification and validation activities in their licensed fields;

(b)

a limited scope of the licence dependent on their personal competence.

Article 22

Additional requirements for environmental verifiers active in third countries

1.   Where an environmental verifier intends to carry out verification and validation activities in third countries, it shall seek accreditation or licence for specific third countries.

2.   In order to obtain accreditation or a licence for a third country, the environmental verifier shall meet, in addition to the requirements set out in Articles 20 and 21, the following requirements:

(a)

knowledge and understanding of the legislative, regulatory and administrative requirements relating to the environment in the third country for which accreditation or a licence is sought;

(b)

knowledge and understanding of the official language of the third country for which accreditation or a licence is sought.

3.   The requirements set out in paragraph 2 shall be deemed to be met where the environmental verifier demonstrates the existence of a contractual relationship between itself and a qualified person or organisation fulfilling those requirements.

That person or organisation shall be independent of the organisation to be verified.

Article 23

Supervision of environmental verifiers

1.   Supervision of verification and validation activities carried out by environmental verifiers in:

(a)

the Member State where they are accredited or licensed shall be carried out by the Accreditation or Licensing Body that granted the accreditation or licence;

(b)

a third country shall be carried out by the Accreditation or Licensing Body that granted the accreditation or licence to the environmental verifier for those activities;

(c)

a Member State other than where the accreditation or licence was granted shall be carried out by the Accreditation or Licensing Body of the Member State where the verification takes place.

2.   At least four weeks in advance of each verification in a Member State, the environmental verifier shall notify its accreditation or licence details and the time and place of the verification to the Accreditation or Licensing Body responsible for the supervision of the environmental verifier concerned.

3.   The environmental verifier shall immediately inform the Accreditation or Licensing Body of any changes which have a bearing on the accreditation or licence or their scope.

4.   Provision shall be made by the Accreditation or Licensing Body, at regular intervals not exceeding 24 months, to ensure that the environmental verifier continues to comply with the accreditation or licence requirements and to monitor the quality of the verification and validation activities undertaken.

5.   Supervision may consist of an office audit, on-the-spot supervision in organisations, questionnaires, a review of environmental statements or updated environmental statements validated by the environmental verifiers and review of the verification report.

Supervision shall be proportionate to the activity undertaken by the environmental verifier.

6.   Organisations must allow the Accreditation or Licensing Bodies to supervise the environmental verifier during the verification and validation process.

7.   Any decision taken by the Accreditation or Licensing Body to terminate or suspend the accreditation or licence or restrict the scope of the accreditation or licence shall be taken only after the environmental verifier has had the possibility of a hearing.

8.   If the supervising Accreditation or Licensing Body is of the opinion that the quality of the work of an environmental verifier does not meet the requirements of this Regulation, a written supervision report shall be transmitted to the environmental verifier concerned and to the Competent Body to which the organisation concerned intends to apply for registration or which registered the organisation concerned.

In the case of any further dispute, the supervision report shall be transmitted to the Forum of Accreditation and Licensing Bodies referred to in Article 30.

Article 24

Additional requirements for supervision of environmental verifiers active in a Member State other than that where the accreditation or license was granted

1.   An environmental verifier accredited or licensed in one Member State shall, at least four weeks before performing verification and validation activities in another Member State, notify to the Accreditation or Licensing Body of the latter Member State the following information:

(a)

its accreditation or licence details, competences, in particular knowledge of legal requirements relating to the environment and official language of the other Member State, and team composition if appropriate;

(b)

the time and place of the verification and validation;

(c)

the address and contact details of the organisation.

That notification shall be provided before each verification and validation activity.

2.   The Accreditation or Licensing Body may request clarification of the verifier's knowledge of the necessary applicable legal requirements relating to the environment.

3.   The Accreditation or Licensing Body may require conditions other than those referred to in paragraph 1 only where those other conditions do not prejudice the right of the environmental verifier to provide services in a Member State other than the one where the accreditation or licence was granted.

4.   The Accreditation or Licensing Body shall not use the procedure referred to in paragraph 1 to delay the arrival of the environmental verifier. Where the Accreditation or Licensing Body is not able to fulfil its tasks in accordance with paragraphs 2 and 3 before the time for verification and validation as notified by the verifier in accordance with paragraph 1(b), it shall communicate a reasoned justification to the verifier.

5.   No discriminatory fees for notification and supervision shall be charged by the Accreditation or Licensing Bodies.

6.   Where the supervising Accreditation or Licensing Body is of the opinion that the quality of the work of the environmental verifier does not meet the requirements of this Regulation, a written supervision report shall be transmitted to the environmental verifier concerned, the Accreditation or Licensing Body which granted the accreditation or licence, and the Competent Body to which the organisation concerned intends to apply for registration or which registered the organisation concerned. In the case of any further dispute the supervision report shall be transmitted to the Forum of Accreditation and Licensing Bodies referred to in Article 30.

Article 25

Conditions for performing verification and validation

1.   The environmental verifier shall operate within the scope of its accreditation or licence, and on the basis of a written agreement with the organisation.

That agreement shall:

(a)

specify the scope of the activity;

(b)

specify conditions aimed at enabling the environmental verifier to operate in an independent professional manner; and

(c)

commit the organisation to providing the necessary cooperation.

2.   The environmental verifier shall ensure that the components of the organisation are unambiguously defined and correspond to a real division of the activities.

The environmental statement shall clearly specify the different parts of the organisation that are subject to verification or validation.

3.   The environmental verifier shall carry out an assessment of the elements set out in Article 18.

4.   As part of the verification and validation activities the environmental verifier shall examine documentation, visit the organisation, carry out spot-checks and conduct interviews with personnel.

5.   Prior to a visit by the environmental verifier, the organisation shall provide it with basic information about the organisation and its activities, the environmental policy and programme, the description of the environmental management system in operation in the organisation, details of the environmental review or audit carried out, the report on that review or audit and on any corrective action taken afterwards, and the draft environmental statement or updated environmental statement.

6.   The environmental verifier shall prepare a written report for the organisation, on the outcome of the verification, which shall specify:

(a)

all issues relevant to the activity carried out by the environmental verifier;

(b)

a description of conformity with all requirements of this Regulation including supporting evidence, findings and conclusions;

(c)

the comparison of the achievements and targets with the previous environmental statements and the environmental performance assessment and assessment of the continuous environmental performance improvement of the organisation;

(d)

if applicable, technical defects in the environmental review, audit method, environmental management system, or any other relevant process.

7.   In cases of non-conformity with the provisions of this Regulation, the report shall specify in addition:

(a)

findings and conclusions on the non-conformity by the organisation and evidence on which those findings and conclusion are based;

(b)

points of disagreement with the draft environmental statement or updated environmental statement, and details of the amendments or additions that should be made to the environmental statement or updated environmental statement.

8.   After verification, the environmental verifier shall validate the organisation's environmental statement or updated environmental statement and confirm that it meets the requirements of this Regulation provided that the outcome of the verification and validation confirms that:

(a)

the information and data in the organisation's environmental statement or updated environmental statement are reliable and correct and meet the requirements of this Regulation; and

(b)

there is no evidence that the organisation does not fulfil applicable legal requirements relating to the environment.

9.   Upon validation, the environmental verifier shall issue a signed declaration as referred to in Annex VII declaring that the verification and validation were carried out in accordance with this Regulation.

10.   Environmental verifiers accredited or licensed in one Member State may perform verification and validation activities in any other Member State in accordance with the requirements set out in this Regulation.

The verification or validation activity shall be subject to supervision by the Accreditation or Licensing Body of the Member State where the activity is to be performed. The start of the activity shall be notified to that Accreditation or Licensing Body in accordance with the timing set out in Article 24(1).

Article 26

Verification and validation of small organisations

1.   When carrying out verification and validation activities, the environmental verifier shall take into account specific characteristics of small organisations, including the following:

(a)

short reporting lines;

(b)

multifunctional staff;

(c)

on-the-job training;

(d)

the ability to adapt rapidly to change; and

(e)

limited documentation of procedures.

2.   The environmental verifier shall conduct verification or validation in a way that does not impose unnecessary burdens on small organisations.

3.   The environmental verifier shall take into account objective evidence that a system is effective, including the existence of procedures within the organisation that are proportionate to the size and complexity of the operation, the nature of the associated environmental impacts and the competence of the operators.

Article 27

Conditions for verification and validation in third countries

1.   Environmental verifiers accredited or licensed in a Member State may perform verification and validation activities for an organisation located in a third country in accordance with the requirements set out in this Regulation.

2.   At least six weeks before verification or validation in a third country, the environmental verifier shall notify its accreditation or licence details and the time and place of the verification or validation to the Accreditation or Licensing Body of the Member State in which the organisation concerned intends to apply for registration or is registered.

3.   The verification and validation activities shall be subject to supervision by the Accreditation or Licensing Body of the Member State in which the environmental verifier is accredited or licensed. The start of the activity shall be notified to that Accreditation or Licensing Body in accordance with the timing set out in paragraph 2.

CHAPTER VI

ACCREDITATION AND LICENSING BODIES

Article 28

Operation of Accreditation and Licensing

1.   Accreditation Bodies appointed by the Member States pursuant to Article 4 of Regulation (EC) No 765/2008 shall be responsible for the accreditation of environmental verifiers and the supervision of the activities carried out by environmental verifiers in accordance with this Regulation.

2.   Member States may appoint a Licensing Body, in accordance with Article 5(2) of Regulation (EC) No 765/2008, which shall be responsible for issuing licences to and supervising environmental verifiers.

3.   Member States may decide not to allow the accreditation or licensing of natural persons as environmental verifiers.

4.   Accreditation and Licensing Bodies shall assess an environmental verifier's competence in the light of the elements set out in Articles 20, 21 and 22 relevant to the scope of the requested accreditation or licence.

5.   The scope of accreditation or the licence of environmental verifiers shall be determined according to the classification of economic activities as set out in Regulation (EC) No 1893/2006. That scope shall be limited by the competence of the environmental verifier and, where appropriate, it shall take into account the size and complexity of the activity.

6.   Accreditation and Licensing Bodies shall establish appropriate procedures on accreditation or licensing, refusal of accreditation or a licence, suspension and withdrawal of accreditation or a licence of environmental verifiers and on supervision of environmental verifiers.

Those procedures shall include mechanisms for considering observations from concerned parties, including Competent Bodies and the representative bodies of organisations, concerning applicants and accredited or licensed environmental verifiers.

7.   In the case of a refusal of accreditation or licence, the Accreditation or Licensing Body shall inform the environmental verifier of the reasons for the decision.

8.   Accreditation or Licensing Bodies shall establish, revise and update a list of environmental verifiers and their scope of accreditation or licence in their Member States and shall communicate each month, directly or via the national authorities as decided by the Member State concerned, changes in that list to the Commission and to the Competent Body of the Member State where the Accreditation or Licensing Body is located.

9.   Within the framework of the rules and procedures regarding monitoring of activities as laid down in Article 5(3) of Regulation (EC) No 765/2008, Accreditation and Licensing Bodies shall draw up a supervision report where they decide, after consultation with the environmental verifier concerned, either of the following:

(a)

that the activities of the environmental verifier were not performed adequately enough to ensure that the requirements of this Regulation are met by the organisation;

(b)

that the verification and the validation by the environmental verifier were carried out in violation of one or more of the requirements of this Regulation.

This report shall be transmitted to the Competent Body in the Member State where the organisation is registered or applies for registration and, if applicable, to the Accreditation or Licensing Body that granted the accreditation or licence.

Article 29

Suspension and withdrawal of accreditation or license

1.   Suspension or withdrawal of the accreditation or licence shall require the consultation of concerned parties including the environmental verifier, in order to provide the Accreditation or Licensing Body with the necessary evidence for taking its decision.

2.   The Accreditation or Licensing Body shall inform the environmental verifier of the reasons for the measures taken and, if applicable, of the process of discussion with the competent enforcement authority.

3.   The accreditation or licence shall be suspended or withdrawn until assurance of the environmental verifier's compliance with this Regulation is obtained, as appropriate, depending on the nature and scope of the failure or violation of legal requirements.

4.   Suspension of the accreditation or licence shall be lifted where the Accreditation or Licensing Body has received satisfactory information that the environmental verifier complies with this Regulation.

Article 30

Forum of the Accreditation and Licensing Bodies

1.   A forum constituted of all the Accreditation and Licensing Bodies from all Member States, hereinafter referred to as ‘the Forum of the Accreditation and Licensing Bodies’, shall be set up and meet at least once per year in the presence of a representative of the Commission.

2.   The task of the Forum of the Accreditation and Licensing Bodies shall be to ensure the consistency of procedures relating to the following:

(a)

the accreditation or licensing of environmental verifiers under this Regulation, including refusal, suspension and withdrawal of accreditation or licence;

(b)

the supervision of activities carried out by accredited or licensed environmental verifiers.

3.   The Forum of the Accreditation and Licensing Bodies shall develop guidance on issues in the field of the competence of Accreditation and Licensing Bodies.

4.   The Forum of the Accreditation and Licensing Bodies shall adopt its rules of procedure.

5.   The guidance documents referred to in paragraph 3 and the rules of procedure referred to in paragraph 4 shall be transmitted to the Commission.

6.   Guidance documents referring to harmonisation procedures approved by the Forum of the Accreditation and Licensing Bodies shall be proposed as appropriate by the Commission for adoption in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).

These documents shall be made publicly available.

Article 31

Peer evaluation of Accreditation and Licensing Bodies

1.   The peer evaluation with regard to accreditation and licensing of environmental verifiers under this Regulation to be organised by the Forum of Accreditation and Licensing Bodies, shall be carried out on a regular basis, at least every four years, and shall include an assessment of the rules and procedures set out in Articles 28 and 29.

All Accreditation and Licensing Bodies shall participate in the peer evaluation.

2.   The Forum of Accreditation and Licensing Bodies shall transmit a regular report of the peer evaluation to the Commission and the Committee established under Article 49(1).

That report shall be made publicly available after approval by the Forum of Accreditation and Licensing Bodies and the Committee referred to in the first subparagraph.

CHAPTER VII

RULES APPLICABLE TO MEMBER STATES

Article 32

Assistance to organisations relating to compliance with legal requirements relating to the environment

1.   Member States shall ensure that organisations get access to information and assistance possibilities regarding legal requirements relating to the environment in that Member State.

2.   The assistance shall include the following:

(a)

information regarding the applicable legal requirements relating to the environment;

(b)

identification of the competent enforcement authorities for specific legal requirements relating to the environment that have been identified as being applicable.

3.   Member States may confer the tasks referred to in paragraphs 1 and 2 to the Competent Bodies or to any other body having the necessary expertise and the appropriate resources to fulfil the task.

4.   Member States shall ensure that enforcement authorities reply to requests, at least from small organisations, on the applicable legal requirements relating to the environment that fall within their competence, and provide information to the organisations on the means of showing how the organisations meet relevant legal requirements.

5.   Member States shall ensure that competent enforcement authorities communicate a failure by registered organisations to comply with applicable legal requirements relating to the environment to the Competent Body which has registered the organisation.

The competent enforcement authority shall inform that Competent Body as soon as possible and in any case within one month after it has become aware of the failure.

Article 33

Promotion of EMAS

1.   Member States shall, in conjunction with Competent Bodies, enforcement authorities and other relevant stakeholders, promote the EMAS scheme taking into account activities referred to in Articles 34 to 38.

2.   To that end, Member States may establish a promotion strategy which shall be revised on a regular basis.

Article 34

Information

1.   Member States shall take appropriate measures to provide information to:

(a)

the public about the objectives and principal components of EMAS;

(b)

organisations about the contents of this Regulation.

2.   Member States shall, where appropriate, use professional publications, local journals, promotion campaigns or any other functional means to increase general awareness of EMAS.

Member States may cooperate, in particular, with industrial associations, consumer organisations, environmental organisations, trade unions, local institutions and other relevant stakeholders.

Article 35

Promotion activities

1.   Member States shall carry out promotion activities for EMAS. These activities may include:

(a)

the promotion of the exchange of knowledge and best practices on EMAS among all concerned parties;

(b)

the development of effective tools for EMAS promotion and to share them with organisations;

(c)

the provision of technical support to organisations in the definition and implementation of their EMAS-related marketing activities;

(d)

the encouragement of partnerships among organisations for EMAS promotion.

2.   The EMAS logo without a registration number may be used by Competent Bodies, Accreditation and Licensing Bodies, national authorities and other stakeholders for EMAS-related marketing and promotional purposes. In such cases, use of the EMAS logo set out in Annex V shall not suggest that the user is registered where this is not the case.

Article 36

Promotion of participation of small organisations

Member States shall take adequate measures to encourage the participation of small organisations, inter alia, by:

(a)

facilitating access to information and support funds specially adapted to them;

(b)

ensuring that reasonable registration fees encourage their participation;

(c)

promoting technical assistance measures.

Article 37

Cluster and step-by-step approach

1.   Member States shall encourage local authorities to provide, in participation with industrial associations, chambers of commerce and other concerned parties, specific assistance to clusters of organisations to meet the requirements for registration as referred to in Articles 4, 5 and 6.

Each organisation from the cluster shall be registered separately.

2.   Member States shall encourage organisations to implement an environment management system. They shall in particular encourage a step-by-step approach leading to EMAS registration.

3.   Systems established pursuant to paragraphs 1 and 2 shall operate with the objective of avoiding unnecessary costs for participants, in particular for small organisations.

Article 38

EMAS and other policies and instruments in the Community

1.   Without prejudice to Community legislation, Member States shall consider how registration under EMAS in accordance with this Regulation can be:

(a)

taken into account in the development of new legislation;

(b)

used as a tool in the application and enforcement of legislation;

(c)

taken into account in public procurement and purchasing.

2.   Without prejudice to Community legislation, notably competition, taxation and State aid legislation, Member States shall, where appropriate, take measures facilitating organisations to become or remain EMAS registered.

Those measures may include, inter alia, the following:

(a)

regulatory relief, so that a registered organisation is considered as being compliant with certain legal requirements relating to the environment laid down in other legal instruments, identified by the competent authorities;

(b)

better regulation, whereby other legal instruments are modified so that burdens on organisations participating in EMAS are removed, reduced or simplified with a view to encouraging the efficient operation of markets and raising the level of competitiveness.

Article 39

Fees

1.   Member States may charge fees taking into account the following:

(a)

the costs incurred in connection with the provision of information and assistance to organisations by the bodies designated or set up to that end by Member States pursuant to Article 32;

(b)

the costs incurred in connection with the accreditation, licensing and supervision of environmental verifiers;

(c)

the costs for registration, renewal of registration, suspension and deletion by Competent Bodies as well as the additional costs of administering those processes for organisations outside the Community.

Those fees shall not exceed a reasonable amount and shall be proportionate to the size of the organisation and to the work to be done.

2.   Member States shall ensure that organisations are informed about all applicable fees.

Article 40

Non-compliance

1.   Member States shall take appropriate legal or administrative measures in case of non-compliance with this Regulation.

2.   Member States shall put in place effective provisions against the use of the EMAS logo in violation of this Regulation.

Provisions put in place in accordance with Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (12) may be used.

Article 41

Information and reporting to the Commission

1.   Member States shall inform the Commission of the structure and procedures relating to the functioning of the Competent Bodies and Accreditation and Licensing Bodies and shall update that information, where appropriate.

2.   Every two years, Member States shall report to the Commission updated information on the measures taken pursuant to this Regulation.

In those reports, Member States shall take account of the latest report presented by the Commission to the European Parliament and to the Council pursuant to Article 47.

CHAPTER VIII

RULES APPLICABLE TO THE COMMISSION

Article 42

Information

1.   The Commission shall provide information to:

(a)

the public on the objectives and principal components of EMAS;

(b)

organisations on the content of this Regulation.

2.   The Commission shall maintain and make publicly available:

(a)

a register of environmental verifiers and registered organisations;

(b)

a database of environmental statements in electronic format;

(c)

a database of best practices on EMAS, including, inter alia, effective tools for EMAS promotion and examples of technical support to organisations;

(d)

a list of Community resources for the funding of EMAS implementation and related projects and activities.

Article 43

Collaboration and coordination

1.   The Commission shall promote, as appropriate, collaboration between Member States in order, in particular, to achieve a uniform and consistent application of the rules throughout the Community relating to the following:

(a)

registration of organisations;

(b)

environmental verifiers;

(c)

the information and assistance referred to in Article 32.

2.   Without prejudice to Community legislation on public procurement, the Commission and other Community institutions and bodies shall, where appropriate, refer to EMAS or other environmental management systems recognised in accordance with Article 45, or equivalent, as contract performance conditions for works and service contracts.

Article 44

Integration of EMAS into other policies and instruments in the Community

The Commission shall consider how registration under EMAS in accordance with this Regulation can be:

1.

taken into account in the development of new legislation and revision of existing legislation, in particular in the form of regulatory relief and better regulation as described in Article 38(2);

2.

used as a tool in the context of application and enforcement of legislation.

Article 45

Relationship with other environmental management systems

1.   Member States may submit to the Commission a written request for recognition of existing environmental management systems, or parts thereof, that are certified in accordance with appropriate certification procedures recognised at national or regional level as complying with corresponding requirements of this Regulation.

2.   Member States shall specify in their request the relevant parts of the environmental management systems and the corresponding requirements of this Regulation.

3.   Member States shall provide evidence of the equivalence with this Regulation of all relevant parts of the environmental management system concerned.

4.   The Commission shall, after examination of the request referred to in paragraph 1, and acting in accordance with the advisory procedure referred to in Article 49(2), recognise the relevant parts of the environmental management systems and recognise the accreditation or licensing requirements for the certification bodies if it is of the opinion that a Member State has:

(a)

specified sufficiently clearly in the request the relevant parts of the environmental management systems and the corresponding requirements of this Regulation;

(b)

provided sufficient evidence of the equivalence with this Regulation of all relevant parts of the environmental management system at stake.

5.   The Commission shall publish the references of the recognised environmental management systems, including the relevant sections of EMAS referred to in Annex I to which those references apply, and the recognised accreditation or licensing requirements in the Official Journal of the European Union.

Article 46

Development of reference documents and guides

1.   The Commission shall, in consultation with Member States and other stakeholders, develop sectoral reference documents that shall include:

(a)

best environmental management practice;

(b)

environmental performance indicators for specific sectors;

(c)

where appropriate, benchmarks of excellence and rating systems identifying environmental performance levels.

The Commission may also develop reference documents for cross-sectoral use.

2.   The Commission shall take into account existing reference documents and environmental performance indicators developed in accordance with other environmental policies and instruments in the Community or international standards.

3.   The Commission shall establish, by the end of 2010, a working plan setting out an indicative list of sectors, which will be considered priorities for the adoption of sectoral and cross-sectoral reference documents.

The working plan shall be made publicly available and regularly updated.

4.   The Commission shall, in cooperation with the Forum of Competent Bodies, develop a guide on registration of organisations outside the Community.

5.   The Commission shall publish a user's guide setting out the steps needed to participate in EMAS.

That guide shall be available in all official languages of the institutions of the European Union and online.

6.   Documents developed in accordance with paragraphs 1 and 4 shall be submitted for adoption. Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).

Article 47

Reporting

Every five years, the Commission shall submit to the European Parliament and to the Council a report containing information on the actions and measures taken under this Chapter and information received from the Member States pursuant to Article 41.

The report shall include an assessment of the impact of the scheme on the environment and the trend in terms of number of participants.

CHAPTER IX

FINAL PROVISIONS

Article 48

Amendment of Annexes

1.   The Commission may amend the Annexes if necessary or appropriate, in the light of experience gained in the operation of EMAS, in response to identified needs for guidance on EMAS requirements and in the light of any changes in international standards or new standards which are of relevance to the effectiveness of this Regulation.

2.   Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).

Article 49

Committee procedure

1.   The Commission shall be assisted by a Committee.

2.   Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 50

Review

The Commission shall review EMAS in the light of the experience gained during its operation and international developments by 11 January 2015. It shall take into account the reports transmitted to the European Parliament and to the Council in accordance with Article 47.

Article 51

Repeal and transitional provisions

1.   The following legal acts shall be repealed:

(a)

Regulation (EC) No 761/2001;

(b)

Commission Decision 2001/681/EC of 7 September 2001 on guidance for the implementation of Regulation (EC) No 761/2001 of the European Parliament and of the Council allowing voluntary participation by organisations in a Community Eco-management and audit scheme (EMAS) (13);

(c)

Commission Decision 2006/193/EC of 1 March 2006 laying down rules, under Regulation (EC) No 761/2001 of the European Parliament and of the Council, on the use of the EMAS logo in the exceptional cases of transport packaging and tertiary packaging (14).

2.   By way of derogation from paragraph 1:

(a)

national Accreditation Bodies and Competent Bodies set up pursuant to Regulation (EC) No 761/2001 shall continue their activities. Member States shall modify the procedures followed by Accreditation Bodies and Competent Bodies in accordance with this Regulation. Member States shall ensure that the systems implementing the modified procedures are fully operational by11 January 2011;

(b)

organisations registered in accordance with Regulation (EC) No 761/2001 shall remain on the EMAS register. At the time of the next verification of an organisation the environmental verifier shall check its compliance with the new requirements of this Regulation. If the next verification is to be carried out before 11 July 2010, the date of the next verification may be extended by six months in agreement with the environmental verifier and the Competent Bodies;

(c)

environmental verifiers accredited in accordance with Regulation (EC) No 761/2001 may continue to perform their activities in accordance with the requirements established by this Regulation.

3.   References to Regulation (EC) No 761/2001 shall be construed as references to this Regulation and be read in accordance with the correlation table set out in Annex VIII.

Article 52

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 25 November 2009.

For the European Parliament

The President

J. BUZEK

For the Council

The President

Å. TORSTENSSON


(1)  Opinion of 25 February 2009 (not yet published in the Official Journal).

(2)  OJ C 120, 28.5.2009, p. 56.

(3)  Opinion of the European Parliament of 2 April 2009 (not yet published in the Official Journal) and Council Decision of 26 October 2009.

(4)  OJ L 242, 10.9.2002, p. 1.

(5)  OJ L 114, 24.4.2001, p. 1.

(6)  OJ L 218, 13.8.2008, p. 30.

(7)  OJ L 247, 17.9.2001, p. 1.

(8)  OJ L 184, 23.7.2003, p. 19.

(9)  OJ L 184, 17.7.1999, p. 23.

(10)  OJ L 124, 20.5.2003, p. 36.

(11)  Regulation (EC) No 1893/2006 of the European Parliament and of the Council of 20 December 2006 establishing the statistical classification of economic activities NACE Revision 2 (OJ L 393, 30.12.2006, p. 1).

(12)  OJ L 149, 11.6.2005, p. 22.

(13)  OJ L 247, 17.9.2001, p. 24.

(14)  OJ L 70, 9.3.2006, p. 63.


ANNEX I

ENVIRONMENTAL REVIEW

The environmental review shall cover the following areas:

1.

Identification of the applicable legal requirements relating to the environment.

In addition to the establishment of a list of applicable legal requirements, the organisation shall also indicate how evidence that it is complying with the different requirements can be provided.

2.

Identification of all direct and indirect environmental aspects with a significant impact on the environment, qualified and quantified as appropriate and compiling a register of those identified as significant;

An organisation shall consider the following issues in assessing the significance of an environmental aspect:

(i)

potential to cause environmental harm;

(ii)

fragility of the local, regional or global environment;

(iii)

size, number, frequency and reversibility of the aspect or impact;

(iv)

existence and requirements of relevant environmental legislation;

(v)

importance to the stakeholders and employees of the organisation.

(a)

Direct environmental aspects

Direct environmental aspects are associated with activities, products and services of the organisation itself over which it has direct management control.

All organisations have to consider the direct aspects of their operations.

Direct environmental aspects relate to, but are not limited to:

(i)

legal requirements and permit limits;

(ii)

emissions to air;

(iii)

releases to water;

(iv)

production, recycling, reuse, transportation and disposal of solid and other wastes, particularly hazardous wastes;

(v)

use and contamination of land;

(vi)

use of natural resources and raw materials (including energy);

(vii)

use of additives and auxiliaries as well as semi-manufactured goods;

(viii)

local issues (noise, vibration, odour, dust, visual appearance, etc.);

(ix)

transport issues (both for goods and services);

(x)

risks of environmental accidents and impacts arising, or likely to arise, as consequences of incidents, accidents and potential emergency situations;

(xi)

effects on biodiversity.

(b)

Indirect environmental aspects

Indirect environmental aspects can result from the interaction of an organisation with third parties which can to a reasonable degree be influenced by the organisation seeking EMAS-registration.

For non-industrial organisations, such as local authorities or financial institutions, it is essential that they also consider the environmental aspects associated with their core business. An inventory limited to the environmental aspects of an organisation's site and facilities is insufficient.

These include, but are not limited to:

(i)

product life cycle related issues (design, development, packaging, transportation, use and waste recovery/disposal);

(ii)

capital investments, granting loans and insurance services;

(iii)

new markets;

(iv)

choice and composition of services (e.g. transport or the catering trade);

(v)

administrative and planning decisions;

(vi)

product range compositions;

(vii)

the environmental performance and practices of contractors, subcontractors and suppliers.

Organisations must be able to demonstrate that the significant environmental aspects associated with their procurement procedures have been identified and that significant environmental impacts associated with these aspects are addressed within the management system. The organisation should endeavour to ensure that the suppliers and those acting on the organisation's behalf comply with the organisation's environmental policy within the remit of the activities carried out for the contract.

In the case of these indirect environmental aspects, an organisation shall consider how much influence it can have over these aspects, and what measures can be taken to reduce the environmental impact.

3.

Description of the criteria for assessing the significance of the environmental impact

An organisation shall define the criteria for assessing the significance of the environmental aspects of its activities, products and services, to determine which have a significant environmental impact.

The criteria developed by an organisation shall take into account Community legislation and shall be comprehensive, capable of independent checking, reproducible and made publicly available.

Considerations in establishing the criteria for assessing the significance of an organisation's environmental aspects may include, but are not limited to:

(a)

information about the condition of the environment to identify activities, products and services of the organisation that may have an environmental impact;

(b)

the organisation's existing data on material and energy inputs, discharges, wastes and emissions in terms of risk;

(c)

views of interested parties;

(d)

environmental activities of the organisation that are regulated;

(e)

procurement activities;

(f)

design, development, manufacturing, distribution, servicing, use, re-use, recycling and disposal of the organisation's products;

(g)

those activities of the organisation with the most significant environmental costs, and environmental benefits.

In assessing the significance of the environmental impacts of the organisation's activities the organisation shall think not only of normal operating conditions but also of start-up and shutdown conditions and of reasonably foreseeable emergency conditions. Account shall be taken of past, present and planned activities.

4.

Examination of all existing environmental management practices and procedures.

5.

Evaluation of feedback from the investigation of previous incidents.


ANNEX II

Environmental management system requirements and additional issues to be addressed by organisations implementing EMAS

The environmental management system requirements under EMAS are those laid down in Section 4 of the EN ISO 14001:2004 standard. These requirements are reproduced in the left column of the table below, which constitutes Part A of this Annex.

In addition, registered organisations are required to address a number of additional issues that have a direct link to a number of elements of Section 4 of the EN ISO 14001:2004 standard. These additional requirements are listed in the right column below, which constitutes Part B of this Annex.

PART A

environmental management systems requirements under EN ISO 14001:2004

PART B

additional issues to be addressed by organisations implementing EMAS

Organisations participating in the eco-management and audit scheme (EMAS) shall implement the requirements of EN ISO 14001:2004, which are described in Section 4 of the European Standard (1) and are fully reproduced below:

 

A.

Environmental management system requirements

 

A.1.

General requirements

 

The organisation shall establish, document, implement, maintain and continually improve an environmental management system in accordance with the requirements of this International Standard and determine how it will fulfill these requirements.

 

The organisation shall define and document the scope of its environmental management system.

 

A.2.

Environmental policy

 

Top management shall define the organisation's environmental policy and ensure that, within the defined scope of its environmental management system, it:

 

(a)

is appropriate to the nature, scale and environmental impacts of its activities, products and services;

 

(b)

includes a commitment to continual improvement and prevention of pollution;

 

(c)

includes a commitment to comply with applicable legal requirements and with other requirements to which the organisation subscribes which relate to its environmental aspects;

 

(d)

provides the framework for setting and reviewing environmental objectives and targets;

 

(e)

is documented, implemented and maintained;

 

(f)

is communicated to all persons working for or on behalf of the organisation; and

 

(g)

is available to the public.

 

A.3.

Planning

 

A.3.1.

Environmental aspects

 

The organisation shall establish, implement and maintain a procedure(s):

 

(a)

to identify the environmental aspects of its activities, products and services within the defined scope of the environmental management system that it can control and those that it can influence taking into account planned or new developments, or new or modified activities, products and services; and

 

(b)

to determine those aspects that have or can have significant impact(s) on the environment (i.e. significant environmental aspects).

 

The organisation shall document this information and keep it up to date.

 

The organisation shall ensure that the significant environmental aspects are taken into account in establishing, implementing and maintaining its environmental management system.

 

 

B.1.

Environmental review

 

Organisations shall carry out an initial environmental review as set out in Annex I in order to identify and evaluate their environmental aspects and identify applicable legal requirements relating to the environment.

 

Organisations outside the Community shall also make reference to the legal requirements relating to the environment applicable to similar organisations in the Member States where they intend to submit an application.

A.3.2.

Legal and other requirements

 

The organisation shall establish, implement and maintain a procedure(s):

 

(a)

to identify and have access to the applicable legal requirements and other requirements to which the organisation subscribes related to its environmental aspects; and

 

(b)

to determine how these requirements apply to its environmental aspects.

 

The organisation shall ensure that these applicable legal requirements and other requirements to which the organisation subscribes are taken into account in establishing, implementing and maintaining its environmental management system.

 

 

B.2.

Legal compliance

 

Organisations wishing to register with EMAS shall be able to demonstrate that they:

 

(1)

have identified, and know the implications to the organisation of all applicable legal requirements relating to the environment, identified during the environmental review according to Annex I.

 

(2)

provide for legal compliance with environmental legislation, including permits and permit limits; and

 

(3)

have procedures in place that enable the organisation to meet these requirements on an ongoing basis.

A.3.3.

Objectives, targets and programme(s)

 

The organisation shall establish, implement and maintain documented environmental objectives and targets, at relevant functions and levels within the organisation.

 

The objectives and targets shall be measurable, where practicable, and consistent with the environmental policy, including the commitments to prevention of pollution, to compliance with applicable legal requirements and with other requirements to which the organisation subscribes, and to continual improvement.

 

When establishing and reviewing its objectives and targets, an organisation shall take into account the legal requirements and other requirements to which the organisation subscribes, and its significant environmental aspects. It shall also consider its technological options, its financial, operational and business requirements, and the views of interested parties.

 

The organisation shall establish, implement and maintain a programme(s) for achieving its objectives and targets. Programme(s) shall include:

 

(a)

designation of responsibility for achieving objectives and targets at relevant functions and levels of the organisation; and

 

(b)

the means and time-frame by which they are to be achieved.

 

 

B.3.

Environmental performance

 

(1)

Organisations shall be able to demonstrate that the management system and the audit procedures address the actual environmental performance of the organisation with respect to the direct and indirect aspects identified in the environmental review under Annex I.

 

(2)

The environmental performance of the organisation against its objectives and targets shall be evaluated as part of the management review process. The organisation shall also commit itself to the continual improvement of its environmental performance. In doing so, the organisation may base its action on local, regional and national environmental programmes.

 

(3)

The means to achieve the objectives and targets cannot be environmental objectives. If the organisation comprises one or more sites, each of the sites to which EMAS applies shall comply with all the requirements of EMAS including the continual improvement of environmental performance as defined in Article 2(2).

A.4.

Implementation and operation

 

A.4.1.

Resources, roles, responsibility and authority

 

Management shall ensure the availability of resources essential to establish, implement, maintain and improve the environmental management system. Resources include human resources and specialised skills, organisational infrastructure, technology and financial resources.

 

Roles, responsibilities and authorities shall be defined, documented and communicated in order to facilitate effective environmental management.

 

The organisation's top management shall appoint a specific management representative(s) who, irrespective of other responsibilities, shall have defined roles, responsibilities and authority for:

 

(a)

ensuring that an environmental management system is established, implemented and maintained in accordance with the requirements of this International Standard;

 

(b)

reporting to top management on the performance of the environmental management system for review, including recommendations for improvement.

 

A.4.2.

Competence, training and awareness

B.4.

Employee involvement

 

(1)

The organisation should acknowledge that active employee involvement is a driving force and a prerequisite for continuous and successful environmental improvements as well as being a key resource in the improvement of environmental performance as well as the right method to anchor the environmental management and audit system in the organisation in a successful way.

 

(2)

The term ‘employee participation’ includes both participation of, and information to the individual employee and his representatives. Therefore, there should be an employee participation scheme at all levels. The organisation should acknowledge that commitment, responsiveness and active support from the side of the management is a prerequisite for the success of those processes. In this context the necessity of feedback from the management to the employees must be stressed.

The organisation shall ensure that any person(s) performing tasks for it or on its behalf that have the potential to cause a significant environmental impact(s) identified by the organisation is (are) competent on the basis of appropriate education, training or experience, and shall retain associated records.

 

The organisation shall identify training needs associated with its environmental aspects and its environmental management system. It shall provide training or take other action to meet these needs, and shall retain associated records.

 

The organisation shall establish, implement and maintain a procedure(s) to make persons working for it or on its behalf aware of:

 

(a)

the importance of conformity with the environmental policy and procedures and with the requirements of the environmental management system;

 

(b)

the significant environmental aspects and related actual or potential impacts associated with their work, and the environmental benefits of improved personal performance;

 

(c)

their roles and responsibilities in achieving conformity with the requirements of the environmental management system; and

 

(d)

the potential consequences of departure from specified procedures.

 

 

(3)

In addition to the these requirements, employees shall be involved in the process aimed at continually improving the organisation's environmental performance through:

 

(a)

the initial environmental review, the analysis of the status quo and in collecting and verifying information,

 

(b)

the establishment and implementation of an environmental management and audit system improving environmental performance,

 

(c)

environmental committees to gather information and to ensure the participation of environmental officer/management representatives and employees and their representatives,

 

(d)

joint working groups for the environmental action programme and environmental auditing,

 

(e)

the elaboration of the environmental statements.

 

(4)

Appropriate forms of participation such as the suggestion-book system or project-based group works or environmental committees should be used for this purpose. Organisations shall take note of Commission guidance on best practice in this field. Where they so request, any employee representatives shall also be involved.

A.4.3.

Communication

 

With regard to its environmental aspects and environmental management system, the organisation shall establish, implement and maintain a procedure(s) for:

 

(a)

internal communication among the various levels and functions of the organisation;

 

(b)

receiving, documenting and responding to relevant communication from external interested parties.

 

The organisation shall decide whether to communicate externally about its significant environmental aspects, and shall document its decision. If the decision is to communicate, the organisation shall establish and implement a method(s) for this external communication.

 

 

B.5.

Communication

 

(1)

Organisations shall be able to demonstrate an open dialogue with the public and other interested parties including local communities and customers with regard to the environmental impact of their activities, products and services in order to identify the public's and other interested parties' concerns.

 

(2)

Openness, transparency and periodic provision of environmental information are key factors in differentiating EMAS from other schemes. Those factors are also important for the organisation in building confidence with interested parties.

 

(3)

EMAS provides flexibility to allow organisations to target relevant information to specific audiences while ensuring that all information is available to those who require it.

A.4.4.

Documentation

 

The environmental management system documentation shall include:

 

(a)

the environmental policy, objectives and targets;

 

(b)

description of the scope of the environmental management system;

 

(c)

description of the main elements of the environmental management system and their interaction, and reference to related documents;

 

(d)

documents, including records, required by this International Standard; and

 

(e)

documents, including records, determined by the organisation to be necessary to ensure the effective planning, operation and control of processes that relate to its significant environmental aspects.

 

A.4.5.

Control of documents

 

Documents required by the environmental management system and by this International Standard shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements given in point A.5.4.

 

The organisation shall establish, implement and maintain a procedure(s) to:

 

(a)

approve documents for adequacy prior to issue;

 

(b)

review and update as necessary and re-approve documents,

 

(c)

ensure that changes and the current revision status of documents are identified;

 

(d)

ensure that relevant versions of applicable documents are available at points of use;

 

(e)

ensure that documents remain legible and readily identifiable;

 

(f)

ensure that documents of external origin determined by the organisation to be necessary for the planning and operation of the environmental management system are identified and their distribution controlled; and

 

(g)

prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose.

 

A.4.6.

Operational control

 

The organisation shall identify and plan those operations that are associated with the identified significant environmental aspects consistent with its environmental policy, objectives and targets, in order to ensure that they are carried out under specified conditions, by:

 

(a)

establishing, implementing and maintaining a documented procedure(s) to control situations where their absence could lead to deviation from the environmental policy, objectives and targets; and

 

(b)

stipulating the operating criteria in the procedure(s); and

 

(c)

establishing, implementing and maintaining procedures related to the identified significant environmental aspects of goods and services used by the organisation and communicating applicable procedures and requirements to suppliers, including contractors.

 

A.4.7.

Emergency preparedness and response

 

The organisation shall establish, implement and maintain a procedure(s) to identify potential emergency situations and potential accidents that can have an impact(s) on the environment and how it will respond to them.

 

The organisation shall respond to actual emergency situations and accidents and prevent or mitigate associated adverse environmental impacts.

 

The organisation shall periodically review and, where necessary, revise its emergency preparedness and response procedures, in particular, after the occurrence of accidents or emergency situations.

 

The organisation shall also periodically test such procedures where practicable.

 

A.5.

Checking

 

A.5.1.

Monitoring and measurement

 

The organisation shall establish, implement and maintain a procedure(s) to monitor and measure, on a regular basis, the key characteristics of its operations that can have a significant environmental impact. The procedure(s) shall include the documenting of information to monitor performance, applicable operational controls and conformity with the organisation's environmental objectives and targets.

 

The organisation shall ensure that calibrated or verified monitoring and measurement equipment is used and maintained and shall retain associated records.

 

A.5.2.

Evaluation of compliance

 

A.5.2.1.

Consistent with its commitment to compliance, the organisation shall establish, implement and maintain a procedure(s) for periodically evaluating compliance with applicable legal requirements.

 

The organisation shall keep records of the results of the periodic evaluations.

 

A.5.2.2.

The organisation shall evaluate compliance with other requirements to which it subscribes. The organisation may wish to combine this evaluation with the evaluation of legal compliance referred to in A.5.2.1 or to establish a separate procedure(s).

 

The organisation shall keep records of the results of the periodic evaluations.

 

A.5.3.

Non-conformity, corrective action and preventive action

 

The organisation shall establish, implement and maintain a procedure(s) for dealing with actual and potential non-conformity(ies) and for taking corrective action and preventive action. The procedure(s) shall define requirements for:

 

(a)

identifying and correcting non-conformity(ies) and taking action(s) to mitigate their environmental impacts;

 

(b)

investigating non-conformity(ies), determining their cause(s) and taking actions in order to avoid their recurrence;

 

(c)

evaluating the need for action(s) to prevent non-conformity(ies) and implementing appropriate actions designed to avoid their occurrence;

 

(d)

recording the results of corrective action(s) and preventive action(s) taken; and

 

(e)

reviewing the effectiveness of corrective action(s) and preventive action(s) taken. Actions taken shall be appropriate to the magnitude of the problems and the environmental impacts encountered.

 

The organisation shall ensure that any necessary changes are made to environmental management system documentation.

 

A.5.4.

Control of records

 

The organisation shall establish and maintain records as necessary to demonstrate conformity to the requirements of its environmental management system and of this International Standard, and the results achieved.

 

The organisation shall establish, implement and maintain a procedure(s) for the identification, storage, protection, retrieval, retention and disposal of records.

 

Records shall be and remain legible, identifiable and traceable.

 

A.5.5.

Internal audit

 

The organisation shall ensure that internal audits of the environmental management system are conducted at planned intervals to:

 

(a)

determine whether the environmental management system:

 

conforms to planned arrangements for environmental management including the requirements of this International Standard, and

 

has been properly implemented and is maintained; and

 

(b)

provide information on the results of audits to management.

 

Audit programme(s) shall be planned, established, implemented and maintained by the organisation, taking into consideration the environmental importance of the operation(s) concerned and the results of previous audits.

 

Audit procedure(s) shall be established, implemented and maintained that address:

 

the responsibilities and requirements for planning and conducting audits, reporting results and retaining associated records,

 

the determination of audit criteria, scope, frequency and methods.

 

Selection of auditors and conduct of audits shall ensure objectivity and the impartiality of the audit process.

 

A.6.

Management review

 

Top management shall review the organisation's environmental management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. Reviews shall include assessing opportunities for improvement and the need for changes to the environmental management system, including the environmental policy and environmental objectives and targets.

 

Records of the management reviews shall be retained.

 

Input to management reviews shall include:

 

(a)

results of internal audits and evaluations of compliance with legal requirements and with other requirements to which the organisation subscribes;

 

(b)

communication(s) from external interested parties, including complaints;

 

(c)

the environmental performance of the organisation;

 

(d)

the extent to which objectives and targets have been met;

 

(e)

status of corrective and preventive actions;

 

(f)

follow-up actions from previous management reviews;

 

(g)

changing circumstances, including developments in legal and other requirements related to its environmental aspects; and

 

(h)

recommendations for improvement.

 

The outputs from management reviews shall include any decisions and actions related to possible changes to environmental policy, objectives, targets and other elements of the environmental management system, consistent with the commitment to continual improvement.

 

List of national standard bodies

BE: IBN/BIN (Institut Belge de Normalisation/Belgisch Instituut voor Normalisatie)

CZ: ČNI (Český normalizační institut)

DK: DS (Dansk Standard)

DE: DIN (Deutsches Institut für Normung e.V.)

EE: EVS (Eesti Standardikeskus)

EL: ELOT (Ελληνικός Οργανισμός Τυποποίησης)

ES: AENOR (Asociacion Espanola de Normalizacion y Certificacion)

FR: AFNOR (Association Française de Normalisation)

IE: NSAI (National Standards Authority of Ireland)

IT: UNI (Ente Nazionale Italiano di Unificazione)

CY: Κυπριακός Οργανισμός Προώθησης Ποιότητας

LV: LVS (Latvijas Standarts)

LT: LST (Lietuvos standartizacijos departamentas)

LU: SEE (Service de l’Energie de l’Etat) (Luxembourg)

HU: MSZT (Magyar Szabványügyi Testület)

MT: MSA (Awtorità Maltija dwar l-Istandards/Malta Standards Authority)

NL: NEN (Nederlands Normalisatie-Instituut)

AT: ON (Österreichisches Normungsinstitut)

PL: PKN (Polski Komitet Normalizacyjny)

PT: IPQ (Instituto Português da Qualidade)

SI: SIST (Slovenski inštitut za standardizacijo)

SK: SÚTN (Slovenský ústav technickej normalizácie)

FI: SFS (Suomen Standardisoimisliitto r.y)

SE: SIS (Swedish Standards Institute)

UK: BSI (British Standards Institution).

 

 

Complementary list of national standard bodies

 

National standard bodies in Member States not covered by EN ISO 14001:2004:

 

BG: BDS (Български институт за стандартизация);

 

RO: ASRO (Asociaţia de Standardizare din România).

 

National standard bodies in Member States, where a national standard body listed in EN ISO 14001:2004 has been replaced:

 

CZ: ÚNMZ (Ústav pro technickou normalizaci, metrologii a státní zkušebnictví).


(1)  The use of the text reproduced in this Annex is made with the permission of the European Committee for Standardisation (CEN). The full text can be purchased from the national standard bodies, the list of which is given in this Annex. Any reproduction of this Annex for commercial reasons is not permitted.


ANNEX III

INTERNAL ENVIRONMENTAL AUDIT

A.   Audit programme and audit frequency

1.   Audit programme

The audit programme shall guarantee that the management of the organisation is provided with the information it needs to review the organisation's environmental performance and the effectiveness of the environmental management system, and be able to demonstrate that they are under control.

2.   Objectives of the audit programme

The objectives shall include, in particular, assessing the management systems in place, and determining conformity with the organisation's policy and programme, which shall include compliance with relevant environmental regulatory requirements.

3.   Scope of the audit programme

The overall scope of the individual audits, or of each stage of an audit cycle where appropriate, shall be clearly defined and shall explicitly specify the:

(a)

subject areas covered;

(b)

activities to be audited;

(c)

environmental criteria to be considered;

(d)

period covered by the audit.

Environmental audit includes assessment of the factual data necessary to evaluate environmental performance.

4.   Audit frequency

The audit or audit cycle which covers all activities of the organisation shall be completed, as appropriate, at intervals of no longer than three years or four years if the derogation provided for in Article 7 applies. The frequency with which any activity is audited will vary depending on the:

(a)

nature, scale and complexity of the activities;

(b)

significance of associated environmental impacts;

(c)

importance and urgency of the problems detected by previous audits;

(d)

history of environmental problems.

More complex activities with a more significant environmental impact shall be audited more frequently.

The organisation shall carry out audits at least on an annual basis, as this will help to demonstrate to the organisation's management and the environmental verifier that it is in control of its significant environmental aspects.

The organisation shall carry out audits regarding:

(a)

the environmental performance of the organisation; and

(b)

the organisation's compliance with applicable legal obligations relating to the environment.

B.   Audit activities

Audit activities shall include discussions with personnel, inspection of operating conditions and equipment and reviewing of records, written procedures and other relevant documentation, with the objective of evaluating the environmental performance of the activity being audited to determine whether it meets the applicable standards, regulations or environmental objectives and targets set and whether the system in place to manage environmental responsibilities is effective and appropriate, inter alia, spot-checking of compliance with these criteria should be used to determine the effectiveness of the entire management system.

The following steps, in particular, shall be included in the audit process:

(a)

understanding of the management systems;

(b)

assessing strengths and weaknesses of the management systems;

(c)

gathering relevant evidence;

(d)

evaluating audit findings;

(e)

preparing audit conclusions;

(f)

reporting audit findings and conclusions.

C.   Reporting audit findings and conclusions

The fundamental objectives of a written audit report are:

(a)

to document the scope of the audit;

(b)

to provide the management with information on the state of compliance with the organisations’ environmental policy and the environmental progress of the organisation;

(c)

to provide the management with information on the effectiveness and reliability of the arrangements for monitoring environmental impacts of the organisation;

(d)

to demonstrate the need for corrective action, where appropriate.


ANNEX IV

ENVIRONMENTAL REPORTING

A.   Introduction

Environmental information shall be presented in a clear and coherent manner in electronic form or in printed form.

B.   Environmental statement

The environmental statement shall contain at least the elements and shall meet the minimum requirements as set out below:

(a)

a clear and unambiguous description of the organisation registering under EMAS and a summary of its activities, products and services and its relationship to any parent organisations as appropriate;

(b)

the environmental policy and a brief description of the environmental management system of the organisation;

(c)

a description of all the significant direct and indirect environmental aspects which result in significant environmental impacts of the organisation and an explanation of the nature of the impacts as related to these aspects (Annex I.2);

(d)

a description of the environmental objectives and targets in relation to the significant environmental aspects and impacts;

(e)

a summary of the data available on the performance of the organisation against its environmental objectives and targets with respect to its significant environmental impacts. Reporting shall be on the core indicators and on other relevant existing environmental performance indicators as set out in Section C;

(f)

other factors regarding environmental performance including performance against legal provisions with respect to their significant environmental impacts;

(g)

a reference to the applicable legal requirements relating to the environment;

(h)

the name and accreditation or licence number of the environmental verifier and the date of validation.

The updated environmental statement shall contain at least the elements and shall meet the minimum requirements as set out in points (e) to (h).

C.   Core indicators and other relevant existing environmental performance indicators

1.   Introduction

Organisations shall report, both in the environmental statement and the updated environmental statement, on the core indicators insofar as these relate to the direct environmental aspects of the organisation and other relevant existing environmental performance indicators as set out below.

The reporting shall provide data on actual input/impact. If disclosure would adversely affect the confidentiality of commercial or industrial information of the organisation where such confidentiality is provided for by national or Community law to protect a legitimate economic interest, the organisation may be permitted to index this information in its reporting, e.g. by establishing a base line year (with the index number 100) from which the development of the actual input/impact would appear.

The indicators shall:

(a)

give an accurate appraisal of the organisation's environmental performance;

(b)

be understandable and unambiguous;

(c)

allow for a year on year comparison to assess the development of the environmental performance of the organisation;

(d)

allow for comparison with sector, national or regional benchmarks as appropriate;

(e)

allow for comparison with regulatory requirements as appropriate.

2.   Core indicators

(a)

Core indicators shall apply to all types of organisations. They focus on performance in the following key environmental areas:

(i)

Energy efficiency;

(ii)

Material efficiency;

(iii)

Water;

(iv)

Waste;

(v)

Biodiversity; and

(vi)

Emissions.

Where an organisation concludes that one or more core indicators are not relevant to its significant direct environmental aspects, that organisation may not report on those core indicators. The organisation shall provide justification to that effect with reference to its environmental review.

(b)

Each core indicator is composed of:

(i)

a figure A indicating the total annual input/impact in the given field;

(ii)

a figure B indicating the overall annual output of the organisation; and

(iii)

a figure R indicating the ratio A/B.

Each organisation shall report on all 3 elements for each indicator.

(c)

The indication of the total annual input/impact in the given field, figure A, shall be reported as follows:

(i)

on Energy efficiency

concerning the ‘total direct energy use’, the total annual energy consumption, expressed in MWh or GJ,

concerning the ‘total renewable energy use’, the percentage of total annual consumption of energy (electricity and heat) produced by the organisation from renewable energy sources,

(ii)

on Material efficiency

concerning the ‘annual mass-flow of different materials used’ (excluding energy carriers and water), expressed in tonnes,

(iii)

on Water

concerning the ‘total annual water consumption’, expressed in m3,

(iv)

on Waste

concerning the ‘total annual generation of waste’, broken down by type, expressed in tonnes,

concerning the ‘total annual generation of hazardous waste’ expressed in kilograms or tonnes,

(v)

on Biodiversity

concerning the ‘use of land’, expressed in m2 of built-up area,

(vi)

on Emissions

concerning the ‘total annual emission of greenhouse gases’, including at least emissions of CO2, CH4, N2O, HFCs, PFCs and SF6, expressed in tonnes of CO2 equivalent,

concerning the ‘total annual air emission’, including at least emissions of SO2, NOx and PM, expressed in kilograms or tonnes,

In addition to the indicators defined above, an organisation may use also other indicators to express the total annual input/impact in the given field;

(d)

The indication of the overall annual output of the organisation, figure B, is the same for all fields, but is adapted to the different types of organisations, depending on their type of activity, and shall be reported as follows:

(i)

for organisations working in the production sector (industry), it shall indicate the total annual gross value-added expressed in million euro (EUR Mio) or total annual physical output expressed in tonnes or, in the case of small organisations the total annual turnover or number of employees;

(ii)

for organisations in the non-production sectors (administration/services), it shall relate to the size of the organisation expressed in number of employees.

In addition to the indicators defined above, an organisation may use also other indicators to express its overall annual output.

3.   Other relevant environmental performance indicators

Each organisation shall also report annually on its performance relating to the more specific environmental aspects as identified in its environmental statement and, where available, take account of sectoral reference documents as referred to in Article 46.

D.   Public availability

The organisation shall be able to demonstrate to the environmental verifier that anybody interested in the organisation's environmental performance can easily and freely be given access to the information required above under points B and C.

The organisation shall ensure that this information is available in (one of) the official language(s) of the Member State, in which the organisation is registered, and if applicable in (one of) the official language(s) of those Member States, in which sites covered by the corporate registration are located.

E.   Local accountability

Organisations registering under EMAS may wish to produce one corporate environmental statement, covering a number of different geographic locations.

As the intention of EMAS is to ensure local accountability, organisations shall ensure that the significant environmental impacts of each site are clearly identified and reported within the corporate environmental statement.


ANNEX V

EMAS LOGO

Image

1.   The logo may be used in any of the 23 languages provided the following wording is used:

Bulgarian

:

‘Проверено управление по околна среда’

Czech

:

‘Ověřený systém environmentálního řízení’

Danish

:

‘Verificeret miljøledelse’

Dutch

:

‘Geverifieerd milieuzorgsysteem’

English

:

‘Verified environmental management’

Estonian

:

‘Tõendatud keskkonnajuhtimine’

Finnish

:

‘Todennettu ympäristöasioiden hallinta’

French

:

‘Management environnemental vérifié’

German

:

‘Geprüftes Umweltmanagement’

Greek

:

‘επιθεωρημένη περιβαλλοντική διαχείριση’

Hungarian

:

‘Hitelesített környezetvédelmi vezetési rendszer’

Italian

:

‘Gestione ambientale verificata’

Irish

:

‘Bainistíocht comhshaoil fíoraithe’

Latvian

:

‘Verificēta vides pārvaldība’

Lithuanian

:

‘Įvertinta aplinkosaugos vadyba’

Maltese

:

‘Immaniggjar Ambjentali Verifikat’

Polish

:

‘Zweryfikowany system zarządzania środowiskowego’

Portuguese

:

‘Gestão ambiental verificada’

Romanian

:

‘Management de mediu verificat’

Slovak:

:

‘Overené environmentálne manažérstvo’

Slovenian

:

‘Preverjen sistem ravnanja z okoljem’

Spanish

:

‘Gestión medioambiental verificada’

Swedish

:

‘Verifierat miljöledningssystem’

2.   The logo shall be used either:

in three colours (Pantone No 355 Green; Pantone No 109 Yellow; Pantone No 286 Blue),

in black,

in white, or,

in a grey scale,


ANNEX VI

INFORMATION REQUIREMENTS FOR REGISTRATION

(information to be provided when applicable)

1.

ORGANISATION

 

Name

Address

Town

Postal Code

Country/land/region/Autonomous Community

Contact person

Telephone

FAX

E-mail

Website

Public access to the environmental statement or the updated environmental statement

 

(a)

printed form

(b)

electronic form

Registration number

Registration date

Suspension date of registration

Deletion date of registration

Date of the next environmental statement

Date of the next updated environmental statement

Request for derogation pursuant to Article 7

YES – NO

NACE Code of activities

Number of employees

Turnover or annual balance sheet

2.

SITE

 

Name

Address

Postal Code

Town

Country land/region/Autonomous Community

Contact person

Telephone

FAX

E-mail

Website

Public access to the environmental statement or the updated environmental statement

 

(a)

printed form

(b)

electronic form

Registration number

Date of registration

Suspension date of registration

Deletion date of registration

Date of the next environmental statement

Date of the next updated environmental statement

Request for derogation pursuant to Article 7

YES – NO

NACE Code of activities

Number of Employees

Turnover/or annual balance sheet

3.

ENVIRONMENTAL VERIFIER

 

Name of environmental verifier

Address

Postal Code

Town

Country/land/region/Autonomous Community

Telephone

FAX

E-mail

Registration number of accreditation or licence

Scope of accreditation or licence (NACE Codes)

Accreditation or Licensing Body

Done at … on …/…/20

Signature of the representative of the organisation


ANNEX VII

ENVIRONMENTAL VERIFIER'S DECLARATION ON VERIFICATION AND VALIDATION ACTIVITIES

… (name).

with EMAS environmental verifier registration number …

accredited or licensed for the scope … (NACE Code)

declares to have verified whether the site(s) or the whole organisation as indicated in the environmental statement/updated environmental statement (1) of the organisation … (name)

with registration number (if available) …

meet all requirements of Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS).

By signing this declaration, I declare that:

the verification and validation has been carried out in full compliance with the requirements of Regulation (EC) No 1221/2009,

the outcome of the verification and validation confirms that there is no evidence of non-compliance with applicable legal requirements relating to the environment,

the data and information of the environmental statement/the updated environmental statement (1) of the organisation/site (1) reflect a reliable, credible and correct image of all the organisations/sites (1) activities, within the scope mentioned in the environmental statement.

This document is not equivalent to EMAS registration. EMAS registration can only be granted by a Competent Body under Regulation (EC) No 1221/2009. This document shall not be used as a stand-alone piece of public communication.

Done at … on …/…/20….

Signature


(1)  cross when non-applicable.


ANNEX VIII

CORRELATION TABLE

Regulation (EC) No 761/2001

this Regulation

Article 1(1)

Article 1

Article 1(2)(a)

Article 1(2)(b)

Article 1(2)(c)

Article 1(2)(d)

Article 2(a)

Article 2(1)

Article 2(b)

Article 2(c)

Article 2(2)

Article 2(d)

Article 2(e)

Article 2(9)

Article 2(f)

Article 2(4)

Article 2(g)

Article 2(8)

Article 2(h)

Article 2(10)

Article 2(i)

Article 2(11)

Article 2(j)

Article 2(12)

Article 2(k)

Article 2(13)

Article 2(l)

Article 2(16)

Article 2(l)(i)

Article 2(l)(ii)

Article 2(m)

Article 2(n)

Article 2(17)

Article 2(o)

Article 2(18)

Article 2(p)

Article 2(q)

Article 2(20)

Article 2(r)

Article 2(s) first subparagraph

Article 2(21)

Article 2(s) second subparagraph

Article 2(t)

Article 2(22)

Article 2(u)

Article 3(1)

Article 3(2)(a) first subparagraph

Article 4(1)(a) and (b)

Article 3(2)(a) second subparagraph

Article 4(3)

Article 3(2)(b)

Article 4(1)(c)

Article 3(2)(c)

Article 4(1)(d)

Article 3(2)(d)

Article 4(5)

Article 3(2)(e)

Article 5(2) first subparagraph; Article 6(3)

Article 3(3)(a)

Article 6(1)(a)

Article 3(3)(b) first sentence

Article 6(1)(b) and (c)

Article 3(3)(b) second sentence

Article 7(1)

Article 4(1)

Article 4(2)

Article 51(2)

Article 4(3)

Article 4(4)

Article 4(5) first sentence

Article 25(10) first subparagraph

Article 4(5) second sentence

Article 25(10) second subparagraph, second sentence

Article 4(6)

Article 41

Article 4(7)

Article 4(8) first subparagraph

Article 30(1)

Article 4(8) second subparagraph

Article 30(3) and (5)

Article 4(8) third subparagraph, first and second sentence

Article 31(1)

Article 4(8) third subparagraph, last sentence

Article 31(2)

Article 5(1)

Article 11(1) first subparagraph

Article 5(2)

Article 11(3)

Article 5(3) first sentence

Article 12(1)

Article 5(3) second sentence, first indent

Article 12(1)(a)

Article 5(3) second sentence, second indent

Article 12(1)(b)

Article 5(4)

Article 11(1) second and third subparagraph

Article 5(5) first sentence

Article 16(1)

Article 5(5) second sentence

Article 16(3) first sentence

Article 5(5) third sentence

Article 17(1)

Article 5(5) fourth sentence

Article 16(3) second subparagraph and Article 16(4) second subparagraph

Article 6(1)

Article 13(1)

Article 6(1), first indent

Article 13(2)(a) and Article 5(2)(a)

Article 6(1), second indent

Article 13(2)(a) and Article 5(2)(c)

Article 6(1), third indent

Article 13(2)(f) and Article 5(2)(d)

Article 6(1), fourth indent

Article 13(2)(c)

Article 6(1), second subparagraph

Article 13(2) first sentence

Article 6(2)

Article 15(3)

Article 6(3), first indent

Article 15(3)(a)

Article 6(3), second indent

Article 15(3)(b)

Article 6(3), third indent

Article 6(3), last sentence

Article 15(8)

Article 6(4), first paragraph

Article 15(2)

Article 6(4), second subparagraph

Article 15(4)

Article 6(5), first sentence

Article 15(6)

Article 6(5), second sentence

Article 15(8) and (9)

Article 6(6)

Article 15(10)

Article 7(1)

Article 28(8)

Article 7(2), first sentence

Article 12(2)

Article 7(2), second sentence

Article 12(3)

Article 7(3)

Article 42(2)(a)

Article 8(1), first sentence

Article 10(1)

Article 8(1), second sentence

Article 10(2)

Article 8(2)

Article 8(3) first subparagraph

Article 10(4)

Article 8(3) second subparagraph

Article 9(1) introductory sentence

Article 4(3)

Article 9(1)(a)

Article 45(4)

Article 9(1)(b)

Article 45(4)

Article 9(1) second subparagraph

Article 45(5)

Article 9(2)

Article 10(1)

Article 10(2), first subparagraph

Article 38(1) and (2)

Article 10(2), second subparagraph, first sentence

Article 41

Article 10(2), second subparagraph, second sentence

Article 47

Article 11(1), first subparagraph

Article 36

Article 11(1), first indent

Article 36(a)

Article 11(1), second indent

Article 36(c)

Article 11(1), third indent

Article 36(b)

Article 11(1), second subparagraph, first sentence

Article 37(1)

Article 11(1), second subparagraph, second sentence

Article 11(1), second subparagraph, third sentence

Article 37(2)

Article 11(1), second subparagraph, fourth sentence

Article 37(3)

Article 11(2)

Article 43(2)

Article 11(3), first sentence

Article 41(2)

Article 11(3), second sentence

Article 47

Article 12(1)(a)

Article 12(1)(b)

Article 35(1)

Article 12(1) second subparagraph

Article 12(2)

Article 41(2)

Article 12(3)

Article 13

Article 40(1)

Article 14(1)

Article 49(1)

Article 14(2)

Article 14(3)

Article 15(1)

Article 50

Article 15(2)

Article 48

Article 15(3)

Article 16(1)

Article 39(1)

Article 16(2)

Article 42(2)

Article 17(1)

Article 17(2), (3) and (4)

Article 51(2)

Article 17(5)

Article 18

Article 52


22.12.2009   

EN

Official Journal of the European Union

L 342/46


REGULATION (EC) No 1222/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 25 November 2009

on the labelling of tyres with respect to fuel efficiency and other essential parameters

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

(1)

Sustainable mobility is a major challenge facing the Community in the light of climate change and the need to support European competitiveness, as emphasised in the Commission Communication of 8 July 2008 entitled ‘Greening Transport’.

(2)

The Commission Communication of 19 October 2006 entitled ‘Action Plan for Energy Efficiency – Realising the Potential’ highlighted the potential for reducing the total energy consumption by 20 % by 2020 by means of a list of targeted actions including the labelling of tyres.

(3)

The Commission Communication of 7 February 2007 entitled ‘Results of the review of the Community strategy to reduce CO2 emissions from passenger cars and light-commercial vehicles’ highlighted the potential for reducing CO2 emissions by means of complementary measures for car components with the highest impact on fuel consumption, such as tyres.

(4)

Tyres, mainly because of their rolling resistance, account for 20 % to 30 % of the fuel consumption of vehicles. A reduction of the rolling resistance of tyres may therefore contribute significantly to the energy efficiency of road transport and thus to the reduction of emissions.

(5)

Tyres are characterised by a number of parameters which are interrelated. Improving one parameter such as rolling resistance may have an adverse impact on other parameters such as wet grip, while improving wet grip may have an adverse impact on external rolling noise. Tyre manufacturers should be encouraged to optimise all parameters beyond the standards already achieved.

(6)

Fuel-efficient tyres are cost-effective since fuel savings more than compensate for the increased purchase price of tyres stemming from higher production costs.

(7)

Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (3) sets out minimum requirements for the rolling resistance of tyres. Technological developments make it possible to significantly decrease energy losses due to tyre rolling resistance beyond those minimum requirements. To reduce the environmental impact of road transport, it is therefore appropriate to lay down provisions to encourage end-users to purchase more fuel-efficient tyres by providing harmonised information on that parameter.

(8)

Traffic noise is a significant nuisance and has a harmful effect on health. Regulation (EC) No 661/2009 sets out minimum requirements for the external rolling noise of tyres. Technological developments make it possible to significantly reduce external rolling noise beyond those minimum requirements. To reduce traffic noise, it is therefore appropriate to lay down provisions to encourage end-users to purchase tyres with low external rolling noise by providing harmonised information on that parameter.

(9)

The provision of harmonised information on external rolling noise would also facilitate the implementation of measures against traffic noise and contribute to increased awareness of the effect of tyres on traffic noise within the framework of Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise (4).

(10)

Regulation (EC) No 661/2009 sets out minimum requirements for the wet grip performance of tyres. Technological developments make it possible to significantly improve wet grip beyond those minimum requirements, and thus to reduce wet braking distances. To improve road safety, it is therefore appropriate to lay down provisions to encourage end-users to purchase tyres with high wet grip performance by providing harmonised information about that parameter.

(11)

The provision of information on wet grip may not reflect the primary performance of tyres specifically designed for snow and ice conditions. Taking into account the fact that harmonised testing methods are not yet available in respect of such tyres, it is appropriate to provide for the possibility of adapting their grip grading at a later stage.

(12)

The provision of information on tyre parameters in the form of a standard label is likely to influence purchasing decisions by end-users in favour of safer, quieter and more fuel-efficient tyres. This, in turn, is likely to encourage tyre manufacturers to optimise those tyre parameters, which would pave the way for more sustainable consumption and production.

(13)

A multiplicity of rules concerning the labelling of tyres across Member States would create barriers to intra-Community trade and increase the administrative burden and testing costs for tyre manufacturers.

(14)

Replacement tyres account for 78 % of the tyre market. It is therefore appropriate to inform the end-user about the parameters of replacement tyres as well as tyres fitted on new vehicles.

(15)

The need for greater information on tyre fuel efficiency and other parameters is relevant for consumers, as well as fleet managers and transport undertakings, which cannot easily compare the parameters of different tyre brands in the absence of a labelling and harmonised testing regime. It is therefore appropriate to include C1, C2 and C3 tyres within the scope of this Regulation.

(16)

The energy label which ranks products on a scale from ‘A’ to ‘G’, as applied to household appliances pursuant to Council Directive 92/75/EEC of 22 September 1992 on the indication by labelling and standard product information of the consumption of energy and other resources by household appliances (5), is well known by consumers and has proven to be successful in promoting more efficient appliances. The same design should be used for the labelling of tyre fuel efficiency.

(17)

The display of a label on tyres at the point of sale, as well as in technical promotional material, should ensure that distributors as well as potential end-users receive harmonised information on tyre fuel efficiency, wet grip performance and external rolling noise at the time and place of the purchasing decision.

(18)

Some end-users choose tyres before arriving at the point of sale, or purchase tyres by mail order. To ensure that those end-users can also make an informed choice on the basis of harmonised information on tyre fuel efficiency, wet grip performance and external rolling noise, labels should be displayed in all technical promotional material, including where such material is made available on the Internet. Technical promotional material does not include advertisements in billboards, newspapers, magazines, radio broadcasting, television and similar online formats.

(19)

Potential end-users should be provided with information explaining each component of the label and its relevance. This information should be provided in technical promotional material, for instance on suppliers’ websites.

(20)

Information should be provided in accordance with harmonised testing methods that should be reliable, accurate and reproducible, in order to enable end-users to compare different tyres and so as to limit testing costs for manufacturers.

(21)

In order to reduce greenhouse gas emissions and increase the safety of road transport, Member States may put in place incentives in favour of fuel-efficient, safer and low noise tyres. It is appropriate that minimum fuel efficiency and wet grip classes be determined below which such incentives may not be granted in order to avoid fragmentation of the internal market. Such incentives may constitute State aid. This Regulation should be without prejudice to the outcome of any future State aid procedure which may be undertaken in accordance with Articles 87 and 88 of the Treaty with respect to such incentives and should not cover taxation and fiscal matters.

(22)

Compliance with the provisions on labelling by suppliers and distributors is essential in order to achieve the aims of those provisions and to ensure a level playing field within the Community. Member States should therefore monitor such compliance through market surveillance and regular ex-post controls, in particular in line with Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (6).

(23)

Member States should refrain, when implementing the relevant provisions of this Regulation, from implementing measures that impose unjustified, bureaucratic and unwieldy obligations on small and medium-sized enterprises.

(24)

Tyre suppliers and distributors should be encouraged to comply with the provisions of this Regulation before 2012 to speed up the recognition of the label and the realisation of its benefits.

(25)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7).

(26)

In particular, the Commission should be empowered to introduce requirements with respect to wet grip grading of C2 and C3 tyres, to adapt the grip grading of tyres specifically designed for snow and ice conditions and to adapt the Annexes, including the testing methods and related allowances, to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(27)

A review of this Regulation should be undertaken to determine end-users’ understanding of the label and the ability of this Regulation to achieve market transformation,

HAVE ADOPTED THIS REGULATION:

Article 1

Aim and subject matter

1.   The aim of this Regulation is to increase the safety, and the economic and environmental efficiency of road transport by promoting fuel-efficient and safe tyres with low noise levels.

2.   This Regulation establishes a framework for the provision of harmonised information on tyre parameters through labelling, allowing end-users to make an informed choice when purchasing tyres.

Article 2

Scope

1.   This Regulation shall apply to C1, C2 and C3 tyres.

2.   This Regulation shall not apply to:

(a)

re-treaded tyres;

(b)

off-road professional tyres;

(c)

tyres designed to be fitted only to vehicles registered for the first time before 1 October 1990;

(d)

T-type temporary-use spare tyres;

(e)

tyres whose speed rating is less than 80 km/h;

(f)

tyres whose nominal rim diameter does not exceed 254 mm or is 635 mm or more;

(g)

tyres fitted with additional devices to improve traction properties, such as studded tyres;

(h)

tyres designed only to be fitted on vehicles intended exclusively for racing.

Article 3

Definitions

For the purpose of this Regulation:

1.

‘C1, C2 and C3 tyres’ means the tyre classes defined in Article 8 of Regulation (EC) No 661/2009;

2.

‘T-type temporary-use spare tyre’ means a temporary-use spare tyre designed for use at inflation pressures higher than those established for standard and reinforced tyres;

3.

‘point of sale’ means a location where tyres are displayed or stored and offered for sale to end-users, including car show rooms in relation to tyres offered for sale to end-users which are not fitted on the vehicles;

4.

‘technical promotional material’ means technical manuals, brochures, leaflets and catalogues (whether these appear in printed, electronic or online form), as well as websites, the purpose of which is to market tyres to end-users or distributors and that describe the specific technical parameters of a tyre;

5.

‘technical documentation’ means information relating to tyres, including the manufacturer and brand of the tyre; description of the tyre type or the grouping of tyres determined for the declaration of the fuel efficiency class, wet grip class and external rolling noise class and measured value; test reports and testing accuracy;

6.

‘manufacturer’ means any natural or legal person who manufactures a product, or has a product designed or manufactured and markets that product under his name or trademark;

7.

‘importer’ means any natural or legal person established within the Community who places a product from a third country on the Community market;

8.

‘authorised representative’ means any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;

9.

‘supplier’ means the manufacturer or its authorised representative in the Community or the importer;

10.

‘distributor’ means any natural or legal person in the supply chain, other than the supplier or the importer, who makes a tyre available on the market;

11.

‘making available on the market’ means any supply of a product for distribution or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;

12.

‘end-user’ means a consumer, as well as a fleet manager or road transport undertaking, that buys or is expected to buy a tyre;

13.

‘essential parameter’ means a tyre parameter such as rolling resistance, wet grip or external rolling noise that has a notable impact on the environment, road safety or health during use.

Article 4

Responsibilities of tyre suppliers

1.   Suppliers shall ensure that C1 and C2 tyres, which are delivered to distributors or end-users, are:

(a)

equipped with a sticker on the tyre tread displaying a label indicating the fuel efficiency class as set out in Annex I, Part A, the external rolling noise class and measured value as set out in Annex I, Part C and, where applicable, the wet grip class as set out in Annex I, Part B,

or

(b)

for each batch of one or more identical tyres delivered, accompanied by a label in printed format indicating the fuel efficiency class as set out in Annex I, Part A, the external rolling noise class and measured value as set out in Annex I, Part C and, where applicable, the wet grip class as set out in Annex I, Part B.

2.   The format of the sticker and the label referred to in paragraph 1 shall be as prescribed in Annex II.

3.   Suppliers shall state the fuel efficiency class, the external rolling noise class and measured value and, where applicable, the wet grip class, of C1, C2 and C3 tyres in technical promotional material, including on their websites, as set out in Annex I, in the order specified in Annex III.

4.   Suppliers shall make technical documentation available to the authorities of Member States on request, for a period ending five years after the last tyre of a given tyre type has been made available on the market. The technical documentation shall be sufficiently detailed as to allow the authorities to verify the accuracy of information provided on the label with regard to fuel efficiency, wet grip and external rolling noise.

Article 5

Responsibilities of tyre distributors

1.   Distributors shall ensure that:

(a)

tyres, at the point of sale, bear the sticker provided by suppliers in accordance with Article 4(1)(a) in a clearly visible position,

or

(b)

before the sale of the tyre, the label referred to in Article 4(1)(b) is shown to the end-user and is clearly displayed in the immediate proximity of the tyre at the point of sale.

2.   Where tyres offered for sale are not visible to the end-user, distributors shall provide end-users with information on the fuel efficiency class, wet grip class and external rolling noise class and measured value of those tyres.

3.   For C1, C2 and C3 tyres, distributors shall state the fuel efficiency class, the external rolling noise measured value and, where applicable, the wet grip class, as set out in Annex I, on or with the bills delivered to end-users when they purchase tyres.

Article 6

Responsibilities of vehicle suppliers and vehicle distributors

Where end users are offered a choice at the point of sale between different tyres to be fitted on a new vehicle which they are intending to acquire, vehicle suppliers and distributors shall, before the sale, provide them with information, for each of the tyres offered, on the fuel efficiency class, the external rolling noise class and measured value, and, where applicable, the wet grip class of C1, C2 and C3 tyres, as set out in Annex I and in the order specified in Annex III. That information shall be included at least in the technical promotional material.

Article 7

Harmonised testing methods

The information to be provided under Articles 4, 5 and 6 on the fuel efficiency class, the external rolling noise class and measured value, and the wet grip class of tyres shall be obtained by applying the harmonised testing methods referred to in Annex I.

Article 8

Verification procedure

Member States shall assess the conformity of the declared fuel efficiency and wet grip classes, within the meaning of Annex I, Parts A and B, and the declared external rolling noise class and measured value within the meaning of Annex I, Part C, in accordance with the procedure set out in Annex IV.

Article 9

Internal market

1.   Where the requirements of this Regulation are complied with, Member States shall neither prohibit nor restrict the making available on the market of the tyres referred to in Article 2 on grounds of product information.

2.   Unless they have evidence to the contrary, Member States shall consider that labels and product information comply with this Regulation. They may require suppliers to provide technical documentation, in accordance with Article 4(4), in order to assess the accuracy of the declared values and classes.

Article 10

Incentives

Member States shall not provide incentives with regard to tyres below class C with respect to either fuel efficiency or wet grip within the meaning of Annex I, Parts A and B respectively. Taxation and fiscal measures do not constitute incentives for the purpose of this Regulation.

Article 11

Amendments and adaptations to technical progress

The following measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(2):

(a)

introduction of information requirements with respect to wet grip grading of C2 and C3 tyres, provided that suitable harmonised testing methods are available;

(b)

adaptation, where relevant, of grip grading to the technical specificities of tyres primarily designed to perform better in ice and/or snow conditions than a normal tyre with regard to their ability to initiate, maintain, or stop vehicle motion;

(c)

adaptation of Annexes I to IV to technical progress.

Article 12

Enforcement

In accordance with Regulation (EC) No 765/2008 Member States shall ensure that the authorities responsible for market surveillance verify compliance with Articles 4, 5 and 6 of this Regulation.

Article 13

Committee procedure

1.   The Commission shall be assisted by a committee.

2.   Where reference is made to this paragraph, Articles 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 14

Review

1.   The Commission shall assess the need to review this Regulation, taking into account, inter alia:

(a)

the effectiveness of the label in terms of end-user awareness, in particular whether the provisions of Article 4(1)(b) are as effective as those of Article 4(1)(a) in contributing to the objectives of this Regulation;

(b)

whether the labelling scheme should be extended to include retreaded tyres;

(c)

whether new tyre parameters, such as mileage, should be introduced;

(d)

the information on tyre parameters provided by vehicle suppliers and distributors to end-users.

2.   The Commission shall present the result of this assessment to the European Parliament and the Council no later than 1 March 2016, and, if appropriate, submit proposals to the European Parliament and to the Council.

Article 15

Transitional provision

Articles 4 and 5 shall not apply to tyres produced before 1 July 2012.

Article 16

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall apply from 1 November 2012.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 25 November 2009.

For the European Parliament

The President

J. BUZEK

For the Council

The President

Å. TORSTENSSON


(1)  OJ C 228, 22.9.2009, p. 81.

(2)  Opinion of the European Parliament of 22 April 2009 (not yet published in the Official Journal), Council Common Position of 20 November 2009 (not yet published in the Official Journal) and Position of the European Parliament of 24 November 2009(not yet published in the Official Journal).

(3)  OJ L 200, 31.7.2009, p. 1.

(4)  OJ L 189, 18.7.2002, p. 12.

(5)  OJ L 297, 13.10.1992, p. 16.

(6)  OJ L 218, 13.8.2008, p. 30.

(7)  OJ L 184, 17.7.1999, p. 23.


ANNEX I

GRADING OF TYRE PARAMETERS

Part A: Fuel efficiency classes

The fuel efficiency class must be determined on the basis of the rolling resistance coefficient (RRC) according to the ‘A’ to ‘G’ scale specified below and measured in accordance with UNECE Regulation No 117 and its subsequent amendments.

If a tyre type is approved for more than one tyre class (e.g. C1 and C2), the grading scale used to determine the fuel efficiency class of this tyre type should be that which is applicable to the highest tyre class (e.g. C2, not C1).

C1 tyres

C2 tyres

C3 tyres

RRC in kg/t

Energy efficiency class

RRC in kg/t

Energy efficiency class

RRC in kg/t

Energy efficiency class

RRC ≤ 6,5

A

RRC ≤ 5,5

A

RRC ≤ 4,0

A

6,6 ≤ RRC ≤ 7,7

B

5,6 ≤ RRC ≤ 6,7

B

4,1 ≤ RRC ≤ 5,0

B

7,8 ≤ RRC ≤ 9,0

C

6,8 ≤ RRC ≤ 8,0

C

5,1 ≤ RRC ≤ 6,0

C

Empty

D

Empty

D

6,1 ≤ RRC ≤ 7,0

D

9,1 ≤ RRC ≤ 10,5

E

8,1 ≤ RRC ≤ 9,2

E

7,1 ≤ RRC ≤ 8,0

E

10,6 ≤ RRC ≤ 12,0

F

9,3 ≤ RRC ≤ 10,5

F

RRC ≥ 8,1

F

RRC ≥ 12,1

G

RRC ≥ 10,6

G

Empty

G

Part B: Wet grip classes

The wet grip class of C1 tyres must be determined on the basis of the wet grip index (G) according to the ‘A’ to ‘G’ scale specified below and measured in accordance with UNECE Regulation No 117 and its subsequent amendments.

G

Wet grip class

1,55 ≤ G

A

1,40 ≤ G ≤ 1,54

B

1,25 ≤ G ≤ 1,39

C

Empty

D

1,10 ≤ G ≤ 1,24

E

G ≤ 1,09

F

Empty

G

Part C: External rolling noise classes and measured value

The external rolling noise measured value (N) must be declared in decibels and calculated in accordance with UNECE Regulation No 117 and its subsequent amendments.

The external rolling noise class must be determined on the basis of the limit values (LV) set out in Part C of Annex II of Regulation (EC) No 661/2009 as follows.

N in dB

External rolling noise class

NLV – 3

Image

LV – 3 < NLV

Image

N > LV

Image


ANNEX II

FORMAT OF THE LABEL

1.   Label design

1.1.   The label referred to in Articles 4(1) and 5(1) must be in accordance with the illustration below:

Image

1.2.   The following provides specifications for the label:

Image

1.3.   The label must be at least 75 mm wide and 110 mm high. Where the label is printed in a larger format, its content must nevertheless remain proportionate to the specifications above.

The label must conform to the following requirements:

(a)

Colours are CMYK – cyan, magenta, yellow and black – and are given following this example: 00-70-X-00: 0 % cyan, 70 % magenta, 100 % yellow, 0 % black;

(b)

The numbers listed below refer to the legends indicated in point 1.2:

Image

Fuel efficiency

Pictogram as supplied: width: 19,5 mm, height: 18,5 mm – Frame for pictogram: stroke: 3,5 pt, width: 26 mm, height: 23 mm – Frame for grading: stroke: 1 pt – Frame end: stroke: 3,5 pt, width: 36 mm – Colour: X-10-00-05;

Image

Wet grip

Pictogram as supplied: width: 19 mm, height: 19 mm – Frame for pictogram: stroke: 3,5 pt, width: 26 mm, height: 23 mm – Frame for grading: stroke: 1 pt – Frame end: stroke: 3,5 pt, width: 26 mm – Colour: X-10-00-05;

Image

External rolling noise

Pictogram as supplied: width: 14 mm, height: 15 mm – Frame for pictogram: stroke: 3,5 pt, width: 26 mm, height: 24 mm – Frame for value: stroke: 1 pt – Frame end: stroke: 3,5 pt, height: 24 mm – Colour: X-10-00-05;

Image

Label border: stroke: 1,5 pt – Colour: X-10-00-05;

Image

‘A’ to ‘G’ scale

Arrows: height: 4,75 mm, gap: 0,75 mm, black stroke: 0,5 pt – colours:

A: X-00-X-00;

B: 70-00-X-00;

C: 30-00-X-00

D: 00-00-X-00;

E: 00-30-X-00

F: 00-70-X-00;

G: 00-X-X-00.

Text: Helvetica Bold 12 pt, 100 % white, black outline: 0,5 pt;

Image

Grading

Arrow: width: 16 mm, height: 10 mm, 100 % black;

Text: Helvetica Bold 27 pt, 100 % white;

Image

Lines in scale: stroke: 0,5 pt, dashed line interval: 5,5 mm, 100 % black;

Image

Scale text: Helvetica Bold 11 pt, 100 % black;

Image

External rolling noise measured value

Arrow: width: 25,25 mm, height: 10 mm, 100 % black;

Text: Helvetica Bold 20 pt, 100 % white;

Unit text: Helvetica Bold 13 pt, 100 % white;

Image

EU logo: width: 9 mm, height: 6 mm;

Image

Regulation reference: Helvetica Regular 7,5 pt, 100 % black;

Tyre class reference: Helvetica Bold 7,5 pt, 100 % black;

Image

External rolling noise class as supplied in part C of Annex I: width: 8,25 mm, height: 15,5 mm – 100 % black

(c)

The background must be white.

1.5.   The tyre class (C1 or C2) must be indicated on the label in the format prescribed in the illustration in point 1.2.

2.   Sticker

2.1.   The sticker referred to in Articles 4(1) and 5(1) consists of two parts: (i) a label printed in the format described in point 1 of this Annex and (ii) a brand space printed in accordance with the specifications described in point 2.2 of this Annex.

2.2.   Brand space: Suppliers must add their trade name or trade mark, the tyre line, tyre dimension, load index, speed rating and other technical specifications on the sticker along with the label, in any colour, format and design, provided that this does not detract from or disrupt the message on the label defined in point 1 of this Annex. The total surface of the sticker shall not exceed 250 cm2 and the total height of the sticker shall not exceed 220 mm.


ANNEX III

Information provided in technical promotional material

1.   Information on tyres must be provided in the order specified as follows:

(i)

the fuel efficiency class (letter ‘A’ to ‘G’);

(ii)

the wet grip class (letter ‘A’ to ‘G’);

(iii)

the external rolling noise class and measured value (dB).

2.   The information provided in point 1 must meet the following requirements:

(i)

be easy to read;

(ii)

be easy to understand;

(iii)

if different grading is available for a given tyre type depending on dimension or other parameters, the range between the least and best performing tyre is stated.

3.   Suppliers must also make the following available on their websites:

(i)

a link to the relevant Commission webpage dedicated to this Regulation;

(ii)

an explanation of the pictograms printed on the label;

(iii)

a statement highlighting the fact that actual fuel savings and road safety depend heavily on the behaviour of drivers, and in particular the following:

eco-driving can significantly reduce fuel consumption,

tyre pressure should be regularly checked to optimise wet grip and fuel efficiency performance,

stopping distances should always be strictly respected,


ANNEX IV

Verification procedure

The conformity of the declared fuel efficiency and wet grip classes as well as the declared external rolling noise class and measured value must be assessed for each tyre type or each grouping of tyres as determined by the supplier, according to one of the following procedures:

(a)

(i)

a single tyre is tested first. If the measured value meets the declared class or external rolling noise measured value, the test is passed;

and

(ii)

if the measured value does not meet the declared class or external rolling noise measured value, three more tyres are tested. The average measurement value stemming from the four tyres tested are used to assess conformity with the declared information;

or

(b)

where the labelled classes or values are derived from type approval test results obtained in accordance with Directive 2001/43/EC, Regulation (EC) No 661/2009, or UNECE Regulation No 117 and its subsequent amendments, Member States may make use of the tyre conformity of production data from these type approvals.

Assessment of conformity of production data must take into account allowances as specified in section 8 of UNECE Regulation No 117 and its subsequent amendments.


22.12.2009   

EN

Official Journal of the European Union

L 342/59


REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 30 November 2009

on cosmetic products

(recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

(1)

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (3) has been significantly amended on several occasions. Since further amendments are to be made, in this particular case it should be recast as one single text in the interests of clarity.

(2)

A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for diverging transposition by Member States. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Community.

(3)

This Regulation aims at simplifying procedures and streamlining terminology, thereby reducing administrative burden and ambiguities. Moreover, it strengthens certain elements of the regulatory framework for cosmetics, such as in-market control, with a view to ensuring a high level of protection of human health.

(4)

This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health.

(5)

The environmental concerns that substances used in cosmetic products may raise are considered through the application of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (4), which enables the assessment of environmental safety in a cross-sectoral manner.

(6)

This Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products. The delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use.

(7)

The assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, taking into account all characteristics of the product. Cosmetic products may include creams, emulsions, lotions, gels and oils for the skin, face masks, tinted bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, toilet waters and eau de Cologne, bath and shower preparations (salts, foams, oils, gels), depilatories, deodorants and anti-perspirants, hair colorants, products for waving, straightening and fixing hair, hair-setting products, hair-cleansing products (lotions, powders, shampoos), hair-conditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines), shaving products (creams, foams, lotions), make-up and products removing make-up, products intended for application to the lips, products for care of the teeth and the mouth, products for nail care and make-up, products for external intimate hygiene, sunbathing products, products for tanning without sun, skin-whitening products and anti-wrinkle products.

(8)

The Commission should define the categories of cosmetic products which are relevant for the application of this Regulation.

(9)

Cosmetic products should be safe under normal or reasonably foreseeable conditions of use. In particular, a risk-benefit reasoning should not justify a risk to human health.

(10)

The presentation of a cosmetic product and in particular its form, odour, colour, appearance, packaging, labelling, volume or size should not endanger health and safety of consumers due to confusion with foodstuffs, in accordance with Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers (5).

(11)

In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community.

(12)

Ensuring traceability of a cosmetic product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators.

(13)

It is necessary to determine under which conditions a distributor is to be considered as the responsible person.

(14)

All legal or natural persons in the wholesale trade as well as retailers selling directly to the consumer are covered by reference to the distributor. The obligations of the distributor should therefore be adapted to the respective role and part of the activity of each of these operators.

(15)

The European cosmetics sector is one of the industrial activities affected by counterfeiting, which may increase risks to human health. Member States should pay particular attention to the implementation of horizontal Community legislation and measures regarding counterfeit products in the field of cosmetic products, for example Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights (6) and Directive 2004/48/EC of the European parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (7). In-market controls represent a powerful means of identifying products that do not comply with the requirements of this Regulation.

(16)

To ensure their safety, cosmetic products placed on the market should be produced according to good manufacturing practice.

(17)

For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located.

(18)

In order to be comparable and of high quality, the results of the non-clinical safety studies carried out for the purposes of assessing the safety of a cosmetic product should comply with the relevant Community legislation.

(19)

It should be made clear which information is to be made available to the competent authorities. That information should include all the necessary particulars relating to identity, quality, safety for human health and the effects claimed for the cosmetic product. In particular, this product information should include a cosmetic product safety report documenting that a safety assessment has been conducted.

(20)

To ensure the uniform application and control of the restrictions for substances, sampling and analysis should be carried out in a reproducible and standardised manner.

(21)

The term ‘mixture’ as defined in this Regulation should have the same meaning as the term ‘preparation’ previously used in Community legislation.

(22)

For reasons of effective market surveillance, the competent authorities should be notified of certain information about the cosmetic product placed on the market.

(23)

In order to allow for rapid and appropriate medical treatment in the event of difficulties, the necessary information about the product formulation should be submitted to poison control centres and assimilated entities, where such centres have been established by Member States to that end.

(24)

In order to keep administrative burdens to a minimum, the notified information for competent authorities, poison control centres and assimilated entities should be submitted centrally for the Community by way of an electronic interface.

(25)

In order to ensure a smooth transition to the new electronic interface, economic operators should be allowed to notify the information required in accordance with this Regulation before its date of application.

(26)

The general principle of the responsibility of the manufacturer or importer for the safety of the product should be supported by restrictions of some substances in Annexes II and III. Moreover, substances which are intended to be used as colorants, preservatives and UV-filters should be listed in the Annexes IV, V and VI respectively in order to be allowed for these uses.

(27)

To avoid ambiguities, it should be clarified that the list of allowed colorants contained in Annex IV includes only substances which colour through absorption and reflection and not substances which colour through photoluminescence, interference, or chemical reaction.

(28)

To address safety concerns raised, Annex IV, which is currently restricted to skin colorants, should also include hair colorants once the risk assessment of these substances by the Scientific Committee for Consumer Safety (SCCS) set up by Commission Decision 2008/721/EC of 5 September 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment (8) has been finalised. To this end, the Commission should have the possibility to include hair colorants in the scope of that Annex by the comitology procedure.

(29)

The use of nanomaterials in cosmetic products may increase with the further development of technology. In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level. The Community should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly.

(30)

At present, there is inadequate information on the risks associated with nanomaterials. In order to better assess their safety the SCCS should provide guidance in cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials.

(31)

The Commission should regularly review the provisions on nanomaterials in the light of scientific progress.

(32)

Given the hazardous properties of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A, 1B and 2, pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (9), their use in cosmetic products should be prohibited. However, as a hazardous property of a substance does not necessarily always entail a risk, there should be a possibility to allow the use of substances classified as CMR 2 substances where, in view of exposure and concentration, they have been found safe for use in cosmetic products by the SCCS and are regulated by the Commission in the Annexes to this Regulation. With regard to substances which are classified as CMR 1A or 1B substances, there should be a possibility, in the exceptional case that these substances comply with food safety requirements, inter alia as a result of their naturally occurring in food, and that no suitable alternative substances exist, to use such substances in cosmetic products on the condition that such use has been found safe by the SCCS. Where such conditions are met, the Commission should amend the relevant Annexes to this Regulation within 15 months of classification of substances as CMR 1A or 1B substances under Regulation (EC) No 1272/2008. Such substances should be continuously reviewed by the SCCS.

(33)

A safety assessment of substances, particularly those classified as CMR 1A or 1B substances, should consider the overall exposure to such substances stemming from all sources. At the same time, for those involved in producing safety assessments, it is essential that there be a harmonised approach to the development and use of such overall exposure estimates. In consequence, the Commission, in close cooperation with the SCCS, the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA) and other relevant stakeholders, should, as a matter of urgency, carry out a review and develop guidance regarding the production and use of overall exposure estimates for these substances.

(34)

The assessment by the SCCS of the use of substances classified as CMR 1A and 1B in cosmetic products should also take into account the exposure to those substances of vulnerable population groups, such as children under three years of age, elderly people, pregnant and breast-feeding women and persons with compromised immune responses.

(35)

The SCCS should give opinions where appropriate on the safety of use of nanomaterials in cosmetic products. These opinions should be based on full information being made available by the responsible person.

(36)

Action by the Commission and Member States relating to the protection of human health should be based on the precautionary principle.

(37)

In order to ensure product safety, prohibited substances should be acceptable at trace levels only if they are technologically inevitable with correct manufacturing processes and provided that the product is safe.

(38)

The Protocol on protection and welfare of animals annexed to the Treaty provides that the Community and the Member States are to pay full regard to the welfare requirements of animals in the implementation of Community policies, in particular with regard to the internal market.

(39)

Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (10) established common rules for the use of animals for experimental purposes within the Community and laid down the conditions under which such experiments must be carried out in the territory of the Member States. In particular, Article 7 of that Directive requires that animal experiments be replaced by alternative methods, where such methods exist and are scientifically satisfactory.

(40)

The safety of cosmetic products and their ingredients may be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, where such methods offer an equivalent level of protection to consumers.

(41)

The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain. Provisions prohibiting animal testing of finished cosmetic products should therefore be laid down. The application, in particular by small and medium-sized enterprises, of both test methods and assessment procedures for relevant available data, including the use of read-across and weight-of-evidence approaches, which do not involve the use of animals for assessing the safety of finished cosmetic products could be facilitated by Commission guidelines.

(42)

It will gradually become possible to ensure the safety of ingredients used in cosmetic products by using non-animal alternative methods validated at Community level, or approved as being scientifically validated, by the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the Organisation for Economic Cooperation and Development (OECD). After consulting the SCCS as regards the applicability of the validated alternative methods to the field of cosmetic products, the Commission should immediately publish the validated or approved methods recognised as being applicable to such ingredients. In order to achieve the highest possible degree of animal protection, a deadline should be set for the introduction of a definitive prohibition.

(43)

The Commission established timetables of deadlines up to 11 March 2009 for prohibiting the marketing of cosmetic products, the final formulation, ingredients or combinations of ingredients which have been tested on animals, and for prohibiting each test currently carried out using animals. In view, however, of tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, it is appropriate for the final deadline for prohibiting the marketing of cosmetic products for which those tests are used to be 11 March 2013. On the basis of annual reports, the Commission should be authorised to adapt the timetables within the abovementioned maximum time limit.

(44)

Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods. It is essential, for this purpose, that the Community continue and increase its efforts and take the measures necessary for the promotion of research and the development of new non-animal alternative methods, in particular within its Framework Programmes for research.

(45)

The recognition by third countries of alternative methods developed in the Community should be encouraged. In order to achieve this objective, the Commission and the Member States should take all appropriate steps to facilitate acceptance of such methods by the OECD. The Commission should also endeavour, within the framework of European Community cooperation agreements, to obtain recognition of the results of safety tests carried out in the Community using alternative methods so as to ensure that the export of cosmetic products for which such methods have been used is not hindered and to prevent or avoid third countries requiring the repetition of such tests using animals.

(46)

Transparency is needed regarding the ingredients used in cosmetic products. Such transparency should be achieved by indication of the ingredients used in a cosmetic product on its packaging. Where for practical reasons it is impossible to indicate the ingredients on the packaging, such information should be enclosed so that the consumer has access to this information.

(47)

A glossary of common ingredient names should be compiled by the Commission to ensure uniform labelling and to facilitate identification of cosmetics ingredients. This glossary should not be intended to constitute a limitative list of substances used in cosmetic products.

(48)

In order to inform consumers, cosmetic products should bear precise and easily understandable indications concerning their durability for use. Given that consumers should be informed of the date until which the cosmetic product will continue to fulfil its initial function and remain safe, it is important to know the date of minimum durability, i.e. the date by which it is best to use the product. Where the minimum durability is more than 30 months, the consumer should be informed of the period of time after opening that the cosmetic product may be used without any harm to the consumer. However, this requirement should not apply where the concept of the durability after opening is not relevant, that is to say for single-use products, products not at risk of deterioration or products which do not open.

(49)

A number of substances have been identified by the SCCS as likely to cause allergic reactions and it will be necessary to restrict their use and/or impose certain conditions concerning them. In order to ensure that consumers are adequately informed, the presence of these substances should be mentioned in the list of ingredients and consumers’ attention should be drawn to the presence of these ingredients. This information should improve the diagnosis of contact allergies among consumers and should enable them to avoid the use of cosmetic products which they do not tolerate. For substances which are likely to cause allergy to a significant part of the population, other restrictive measures such as a ban or a restriction of concentration should be considered.

(50)

In the safety assessment of a cosmetic product it should be possible to take into account results of risk assessments that have been carried out in other relevant areas. The use of such data should be duly substantiated and justified.

(51)

The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products. In particular Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (11) is applicable. Furthermore, the Commission, in cooperation with Member States, should define common criteria in relation to specific claims for cosmetic products.

(52)

It should be possible to claim on a cosmetic product that no animal testing was carried out in relation to its development. The Commission, in consultation with the Member States, has developed guidelines to ensure that common criteria are applied in the use of claims and that an aligned understanding of the claims is reached, and in particular that such claims do not mislead the consumer. In developing such guidelines, the Commission has also taken into account the views of the many small and medium-sized enterprises which make up the majority of the ‘non-animal testing’ producers, relevant non-governmental organisations, and the need for consumers to be able to make practical distinctions between products on the basis of animal testing criteria.

(53)

In addition to the labelled information, consumers should be given the possibility to request certain product-related information from the responsible person in order to make informed product choices.

(54)

Effective market surveillance is necessary in order to ensure that the provisions of this Regulation are respected. To this end, serious undesirable effects should be notified and competent authorities should have a possibility to request from the responsible person a list of cosmetic products containing substances which have raised serious doubts in terms of safety.

(55)

This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the notification by health professionals or consumers of serious undesirable effects to the competent authorities of Member States.

(56)

This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the establishment of economic operators in the area of cosmetic products.

(57)

In case of non-compliance with this Regulation, a clear and efficient procedure for the withdrawal and recall of products may be necessary. This procedure should, where possible, build upon existing Community rules for unsafe goods.

(58)

In order to address cosmetic products which, despite complying with the provisions of this Regulation, might endanger human health, a safeguard procedure should be introduced.

(59)

The Commission should provide indications for the uniform interpretation and application of the concept of serious risks in order to facilitate the consistent implementation of this Regulation.

(60)

In order to comply with principles of good administrative practices, any decision by a competent authority in the framework of market surveillance should be duly substantiated.

(61)

In order to ensure effective in-market control, a high degree of administrative cooperation amongst the competent authorities is necessary. This concerns in particular mutual assistance in the verification of product information files located in another Member State.

(62)

The Commission should be assisted by the SCCS, an independent risk assessment body.

(63)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12).

(64)

In particular, power should be conferred on the Commission to adapt the Annexes to this Regulation to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(65)

When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of certain measures relating to CMRs, nanomaterials and potential risks to human health.

(66)

Member States should lay down provisions on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.

(67)

Economic operators as well as Member States and the Commission need sufficient time to adapt to the changes introduced by this Regulation. Therefore it is appropriate to provide for a sufficient transitional period for that adaptation. However, in order to ensure a smooth transition, economic operators should be allowed to place on the market cosmetic products which comply with this Regulation before the expiry of that transitional period.

(68)

In order to enhance the safety of cosmetic products and strengthen the market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, the product information file and notification, even if similar obligations have already been fulfilled under Directive 76/768/EEC.

(69)

Directive 76/768/EEC should be repealed. However, in order to ensure appropriate medical treatment in the event of difficulties and to ensure market surveillance, the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC concerning cosmetic products should be kept by the competent authorities for a certain period of time and the information kept by the responsible person should remain available for the same period of time.

(70)

This Regulation should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex IX.

(71)

Since the objective of this Regulation, namely the achievement of the internal market and a high level of protection of human health through the compliance of cosmetic products with the requirements laid down in this Regulation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SCOPE, DEFINITIONS

Article 1

Scope and objective

This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.

Article 2

Definitions

1.   For the purposes of this Regulation, the following definitions shall apply:

(a)

‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

(b)

‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

(c)

‘mixture’ means a mixture or solution composed of two or more substances;

(d)

‘manufacturer’ means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark;

(e)

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market;

(f)

‘end user’ means either a consumer or professional using the cosmetic product;

(g)

‘making available on the market’ means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;

(h)

‘placing on the market’ means the first making available of a cosmetic product on the Community market;

(i)

‘importer’ means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market;

(j)

‘harmonised standard’ means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services (13) on the basis of a request made by the Commission in accordance with Article 6 of that Directive;

(k)

‘nanomaterial’ means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm;

(l)

‘preservatives’ means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product;

(m)

‘colorants’ means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of visible light; in addition, precursors of oxidative hair colorants shall be deemed colorants;

(n)

‘UV-filters’ means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation;

(o)

‘undesirable effect’ means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product;

(p)

‘serious undesirable effect’ means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death;

(q)

‘withdrawal’ means any measure aimed at preventing the making available on the market of a cosmetic product in the supply chain;

(r)

‘recall’ means any measure aimed at achieving the return of a cosmetic product that has already been made available to the end user;

(s)

‘frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. The Commission shall provide indications for the establishment of the frame formulation and adapt them regularly to technical and scientific progress.

2.   For the purposes of point (a) of paragraph 1, a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product.

3.   In view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt point (k) of paragraph 1 to technical and scientific progress and to definitions subsequently agreed at international level. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

CHAPTER II

SAFETY, RESPONSIBILITY, FREE MOVEMENT

Article 3

Safety

A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following:

(a)

presentation including conformity with Directive 87/357/EEC;

(b)

labelling;

(c)

instructions for use and disposal;

(d)

any other indication or information provided by the responsible person defined in Article 4.

The provision of warnings shall not exempt persons defined in Articles 2 and 4 from compliance with the other requirements laid down in this Regulation.

Article 4

Responsible person

1.   Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market.

2.   For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.

3.   For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person.

The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.

4.   Where, for a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.

5.   For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market.

The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing.

6.   The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.

The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of this Regulation may be affected.

Article 5

Obligations of responsible persons

1.   Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2) and (5), as well as Articles 20, 21, 23 and 24.

2.   Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.

Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the product information file is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures taken.

3.   Responsible persons shall cooperate with these authorities, at the request of the latter, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, responsible persons shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of specific aspects of the product, in a language which can be easily understood by that authority.

Article 6

Obligations of distributors

1.   In the context of their activities, when making a cosmetic product available on the market, distributors shall act with due care in relation to applicable requirements.

2.   Before making a cosmetic product available on the market distributors shall verify that:

the labelling information provided for in Article 19(1)(a), (e) and (g) and Article 19(3) and (4) is present,

the language requirements provided for in Article 19(5) are fulfilled,

the date of minimum durability specified, where applicable under Article 19(1), has not passed.

3.   Where distributors consider or have reason to believe that:

a cosmetic product is not in conformity with the requirements laid down in this Regulation, they shall not make the product available on the market until it has been brought into conformity with the applicable requirements,

a cosmetic product which they have made available on the market is not in conformity with this Regulation, they shall make sure that the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate, are taken.

Furthermore, where the cosmetic product presents a risk to human health, distributors shall immediately inform the responsible person and the competent national authorities of the Member States in which they made the product available, giving details, in particular, of the non-compliance and of the corrective measures taken.

4.   Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in this Regulation.

5.   Distributors shall cooperate with competent authorities, at the request of the latter, on any action to eliminate the risks posed by products which they have made available on the market. In particular, distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product with the requirements listed under paragraph 2, in a language which can be easily understood by that authority.

Article 7

Identification within the supply chain

At the request of a competent authority:

responsible persons shall identify the distributors to whom they supply the cosmetic product,

the distributor shall identify the distributor or the responsible person from whom, and the distributors to whom, the cosmetic product was supplied.

This obligation shall apply for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor.

Article 8

Good manufacturing practice

1.   The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1.

2.   Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.

Article 9

Free movement

Member States shall not, for reasons related to the requirements laid down in this Regulation, refuse, prohibit or restrict the making available on the market of cosmetic products which comply with the requirements of this Regulation.

CHAPTER III

SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION

Article 10

Safety assessment

1.   In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.

The responsible person shall ensure that:

(a)

the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;

(b)

an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources;

(c)

the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.

The first subparagraph shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.

The Commission, in close cooperation with all stakeholders, shall adopt appropriate guidelines to enable undertakings, in particular small and medium-sized enterprises, to comply with the requirements laid down in Annex I. Those guidelines shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).

2.   The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.

3.   Non-clinical safety studies referred to in the safety assessment according to paragraph 1 and carried out after 30 June 1988 for the purpose of assessing the safety of a cosmetic product shall comply with Community legislation on the principles of good laboratory practice, as applicable at the time of performance of the study, or with other international standards recognised as being equivalent by the Commission or the ECHA.

Article 11

Product information file

1.   When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

2.   The product information file shall contain the following information and data which shall be updated as necessary:

(a)

a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;

(b)

the cosmetic product safety report referred to in Article 10(1);

(c)

a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;

(d)

where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;

(e)

data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.

3.   The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.

The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State.

4.   The requirements provided in paragraphs 1 to 3 of this Article shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.

Article 12

Sampling and analysis

1.   Sampling and analysis of cosmetic products shall be performed in a reliable and reproducible manner.

2.   In the absence of any applicable Community legislation, reliability and reproducibility shall be presumed if the method used is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.

Article 13

Notification

1.   Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission:

(a)

the category of cosmetic product and its name or names, enabling its specific identification;

(b)

the name and address of the responsible person where the product information file is made readily accessible;

(c)

the country of origin in the case of import;

(d)

the Member State in which the cosmetic product is to be placed on the market;

(e)

the contact details of a physical person to contact in the case of necessity;

(f)

the presence of substances in the form of nanomaterials and:

(i)

their identification including the chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI to this Regulation;

(ii)

the reasonably foreseeable exposure conditions;

(g)

the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008;

(h)

the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.

The first subparagraph shall also apply to cosmetic products notified under Directive 76/768/EEC.

2.   When the cosmetic product is placed on the market, the responsible person shall notify to the Commission the original labelling, and, where reasonably legible, a photograph of the corresponding packaging.

3.   As from 11 July 2013, a distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, shall submit, by electronic means, the following information to the Commission:

(a)

the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification;

(b)

the Member State in which the cosmetic product is made available;

(c)

his name and address;

(d)

the name and address of the responsible person where the product information file is made readily accessible..

4.   Where a cosmetic product has been placed on the market before 11 July 2013 but is no longer placed on the market as from that date, and a distributor introduces that product in a Member State after that date, that distributor shall communicate the following to the responsible person:

(a)

the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification;

(b)

the Member State in which the cosmetic product is made available;

(c)

his name and address.

On the basis of that communication, the responsible person shall submit to the Commission, by electronic means, the information referred to in paragraph 1 of this Article, where notifications according to Article 7(3) and Article 7a (4) of Directive 76/768/EEC have not been carried out in the Member State in which the cosmetic product is made available.

5.   The Commission shall, without delay, make the information referred to in points (a) to (g) of paragraph 1, and in paragraphs 2 and 3 available electronically to all competent authorities.

That information may be used by competent authorities only for the purposes of market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.

6.   The Commission shall, without delay, make the information referred to in paragraphs 1, 2 and 3 available electronically to poison centres or similar bodies, where such centres or bodies have been established by Member States.

That information may be used by those bodies only for the purposes of medical treatment.

7.   Where any of the information set out in paragraphs 1, 3 and 4 changes, the responsible person or the distributor shall provide an update without delay.

8.   The Commission may, taking into account technical and scientific progress and specific needs related to market surveillance, amend paragraphs 1 to 7 by adding requirements.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

CHAPTER IV

RESTRICTIONS FOR CERTAIN SUBSTANCES

Article 14

Restrictions for substances listed in the Annexes

1.   Without prejudice to Article 3, cosmetic products shall not contain any of the following:

(a)

prohibited substances

prohibited substances listed in Annex II;

(b)

restricted substances

restricted substances which are not used in accordance with the restrictions laid down in Annex III;

(c)

colorants

(i)

colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that Annex, except for hair colouring products referred to in paragraph 2;

(ii)

without prejudice to points (b), (d)(i) and (e)(i), substances which are listed in Annex IV but which are not intended to be used as colorants, and which are not used in accordance with the conditions laid down in that Annex;

(d)

preservatives

(i)

preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that Annex;

(ii)

without prejudice to points (b), (c)(i) and (e)(i), substances listed in Annex V but which are not intended to be used as preservatives, and which are not used in accordance with the conditions laid down in that Annex;

(e)

UV-filters

(i)

UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that Annex;

(ii)

without prejudice to points (b), (c)(i) and (d)(i), substances listed in Annex VI but which are not intended to be used as UV-filters and which are not used in accordance with the conditions laid down in that Annex.

2.   Subject to a decision of the Commission to extend the scope of Annex IV to hair colouring products, such products shall not contain colorants intended to colour the hair, other than those listed in Annex IV and colorants intended to colour the hair which are listed there but not used in accordance with the conditions laid down in that Annex.

The decision of the Commission referred to in the first subparagraph, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

Article 15

Substances classified as CMR substances

1.   The use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation.

2.   The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.

However, such substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008, all of the following conditions are fulfilled:

(a)

they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (14);

(b)

there are no suitable alternative substances available, as documented in an analysis of alternatives;

(c)

the application is made for a particular use of the product category with a known exposure; and

(d)

they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.

Specific labelling in order to avoid misuse of the cosmetic product shall be provided in accordance with Article 3 of this Regulation, taking into account possible risks linked to the presence of hazardous substances and the routes of exposure.

In order to implement this paragraph, the Commission shall amend the Annexes to this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation within 15 months of the inclusion of the substances concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4) of this Regulation.

The Commission shall mandate the SCCS to re-evaluate those substances as soon as safety concerns arise, and at the latest five years after their inclusion in Annexes III to VI to this Regulation, and at least every subsequent five years.

3.   By 11 January 2012, the Commission shall ensure that appropriate guidance is developed with the aim of enabling a harmonised approach to the development and use of overall exposure estimates in assessing the safe use of CMR substances. This guidance shall be developed in consultation with the SCCS, the ECHA, the EFSA and other relevant stakeholders, drawing, as appropriate, on relevant best practice.

4.   When Community or internationally agreed criteria for identifying substances with endocrine-disrupting properties are available, or at the latest on 11 January 2015, the Commission shall review this Regulation with regard to substances with endocrine-disrupting properties.

Article 16

Nanomaterials

1.   For every cosmetic product that contains nanomaterials, a high level of protection of human health shall be ensured.

2.   The provisions of this Article do not apply to nanomaterials used as colorants, UV-filters or preservatives regulated under Article 14, unless expressly specified.

3.   In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person by electronic means six months prior to being placed on the market, except where they have already been placed on the market by the same responsible person before 11 January 2013.

In the latter case, cosmetic products containing nanomaterials placed on the market shall be notified to the Commission by the responsible person between 11 January 2013 and 11 July 2013 by electronic means, in addition to the notification in Article 13.

The first and the second subparagraphs shall not apply to cosmetic products containing nanomaterials that are in conformity with the requirements set out in Annex III.

The information notified to the Commission shall contain at least the following:

(a)

the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI;

(b)

the specification of the nanomaterial including size of particles, physical and chemical properties;

(c)

an estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year;

(d)

the toxicological profile of the nanomaterial;

(e)

the safety data of the nanomaterial relating to the category of cosmetic product, as used in such products;

(f)

the reasonably foreseeable exposure conditions.

The responsible person may designate another legal or natural person by written mandate for the notification of nanomaterials and shall inform the Commission thereof.

The Commission shall provide a reference number for the submission of the toxicological profile, which may substitute the information to be notified under point (d).

4.   In the event that the Commission has concerns regarding the safety of a nanomaterial, the Commission shall, without delay, request the SCCS to give its opinion on the safety of such nanomaterial for use in the relevant categories of cosmetic products and on the reasonably foreseeable exposure conditions. The Commission shall make this information public. The SCCS shall deliver its opinion within six months of the Commission's request. Where the SCCS finds that any necessary data is lacking, the Commission shall request the responsible person to provide such data within an explicitly stated reasonable time, which shall not be extended. The SCCS shall deliver its final opinion within six months of submission of additional data. The opinion of the SCCS shall be made publicly available.

5.   The Commission may, at any time, invoke the procedure in paragraph 4 where it has any safety concerns, for example due to new information supplied by a third party.

6.   Taking into account the opinion of the SCCS, and where there is a potential risk to human health, including when there is insufficient data, the Commission may amend Annexes II and III.

7.   The Commission may, taking into account technical and scientific progress, amend paragraph 3 by adding requirements.

8.   The measures, referred to in paragraphs 6 and 7, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

9.   On imperative grounds of urgency the Commission may use the procedure referred to in Article 32(4).

10.   The following information shall be made available by the Commission:

(a)

By 11 January 2014, the Commission shall make available a catalogue of all nanomaterials used in cosmetic products placed on the market, including those used as colorants, UV-filters and preservatives in a separate section, indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions. This catalogue shall be regularly updated thereafter and be made publicly available.

(b)

The Commission shall submit to the European Parliament and the Council an annual status report, which will give information on developments in the use of nanomaterials in cosmetic products within the Community, including those used as colorants, UV-filters and preservatives in a separate section. The first report shall be presented by 11 July 2014 The report update shall summarise, in particular, the new nanomaterials in new categories of cosmetic products, the number of notifications, the progress made in developing nano-specific assessment methods and safety assessment guides, and information on international cooperation programmes.

11.   The Commission shall regularly review the provisions of this Regulation concerning nanomaterials in the light of scientific progress and shall, where necessary, propose suitable amendments to those provisions.

The first review shall be undertaken by 11 July 2018.

Article 17

Traces of prohibited substances

The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.

CHAPTER V

ANIMAL TESTING

Article 18

Animal testing

1.   Without prejudice to the general obligations deriving from Article 3, the following shall be prohibited:

(a)

the placing on the market of cosmetic products where the final formulation, in order to meet the requirements of this Regulation, has been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;

(b)

the placing on the market of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Regulation, have been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;

(c)

the performance within the Community of animal testing of finished cosmetic products in order to meet the requirements of this Regulation;

(d)

the performance within the Community of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Regulation, after the date on which such tests are required to be replaced by one or more validated alternative methods listed in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (15) or in Annex VIII to this Regulation.

2.   The Commission, after consulting the SCCS and the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the OECD, has established timetables for the implementation of the provisions under points (a), (b) and (d) of paragraph 1, including deadlines for the phasing-out of the various tests. The timetables were made available to the public on 1 October 2004 and sent to the European Parliament and the Council. The period for implementation was limited to 11 March 2009 in relation to points (a), (b) and (d) of paragraph 1.

In relation to the tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration, the period for implementation of paragraph 1(a) and (b) shall be limited to 11 March 2013.

The Commission shall study possible technical difficulties in complying with the ban in relation to tests, in particular those concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration. Information about the provisional and final results of these studies forms part of the yearly reports presented pursuant to Article 35.

On the basis of these annual reports, the timetables established as referred to in the first subparagraph, could be adapted up to 11 March 2009 in relation to the first subparagraph and may be adapted up to 11 March 2013 in relation to the second subparagraph and after consultation of the entities referred to in the first subparagraph.

The Commission shall study progress and compliance with the deadlines as well as possible technical difficulties in complying with the ban. Information about the provisional and final results of the Commission studies forms part of the yearly reports presented pursuant to Article 35. If these studies conclude, at the latest two years prior to the end of the maximum period referred to in the second subparagraph, that for technical reasons one or more tests referred to in that subparagraph will not be developed and validated before the expiry of the period referred to therein it shall inform the European Parliament and the Council and shall put forward a legislative proposal in accordance with Article 251 of the Treaty.

In exceptional circumstances, where serious concerns arise as regards the safety of an existing cosmetic ingredient, a Member State may request the Commission to grant a derogation from paragraph 1. The request shall contain an evaluation of the situation and indicate the measures necessary. On this basis, the Commission may, after consulting the SCCS and by means of a reasoned decision, authorise the derogation. That authorisation shall lay down the conditions associated with this derogation in terms of specific objectives, duration and reporting of the results.

A derogation shall be granted only where:

(a)

the ingredient is in wide use and cannot be replaced by another ingredient capable of performing a similar function;

(b)

the specific human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research protocol proposed as the basis for the evaluation.

The decision on the authorisation, the conditions associated with it and the final result achieved shall be part of the annual report presented by the Commission in accordance with Article 35.

The measures referred to in the sixth subparagraph, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

3.   For the purposes of this Article and Article 20:

(a)

‘finished cosmetic product’ means the cosmetic product in its final formulation, as placed on the market and made available to the end user, or its prototype;

(b)

‘prototype’ means a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed.

CHAPTER VI

CONSUMER INFORMATION

Article 19

Labelling

1.   Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering:

(a)

the name or registered name and the address of the responsible person. Such information may be abbreviated in so far as the abbreviation makes it possible to identify that person and his address. If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted. The country of origin shall be specified for imported cosmetic products;

(b)

the nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than five grams or five millilitres, free samples and single-application packs; for pre-packages normally sold as a number of items, for which details of weight or volume are not significant, the content need not be given provided the number of items appears on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually;

(c)

the date until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function and, in particular, will remain in conformity with Article 3 (‘date of minimum durability’).

The date itself or details of where it appears on the packaging shall be preceded by the symbol shown in point 3 of Annex VII or the words: ‘best used before the end of’.

The date of minimum durability shall be clearly expressed and shall consist of either the month and year or the day, month and year, in that order. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.

Indication of the date of minimum durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product is safe and can be used without any harm to the consumer. This information shall be indicated, except where the concept of durability after opening is not relevant, by the symbol shown in point 2 of Annex VII followed by the period (in months and/or years);

(d)

particular precautions to be observed in use, and at least those listed in Annexes III to VI and any special precautionary information on cosmetic products for professional use;

(e)

the batch number of manufacture or the reference for identifying the cosmetic product. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging;

(f)

the function of the cosmetic product, unless it is clear from its presentation;

(g)

a list of ingredients. This information may be indicated on the packaging alone. The list shall be preceded by the term ‘ingredients’.

For the purpose of this Article, an ingredient means any substance or mixture intentionally used in the cosmetic product during the process of manufacturing. The following shall not, however, be regarded as ingredients:

(i)

impurities in the raw materials used;

(ii)

subsidiary technical materials used in the mixture but not present in the final product.

Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’. Moreover, the presence of substances, the mention of which is required under the column ‘Other’ in Annex III, shall be indicated in the list of ingredients in addition to the terms parfum or aroma.

The list of ingredients shall be established in descending order of weight of the ingredients at the time they are added to the cosmetic product. Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.

All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.

Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients. For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added. The CI (Colour Index) nomenclature shall be used, where applicable.

2.   Where it is impossible for practical reasons to label the information mentioned in points (d) and (g) of paragraph 1 as provided, the following applies:

the information shall be mentioned on an enclosed or attached leaflet, label, tape, tag or card;

unless impracticable, this information shall be referred to by abbreviated information or the symbol given in point 1 of Annex VII, which must appear on the container or packaging for the information referred in point (d) of paragraph 1 and on packaging for the information referred in point (g) of paragraph 1.

3.   In the case of soap, bath balls and other small products where it is impossible for practical reasons for the information referred to in point (g) of paragraph 1 to appear on a label, tag, tape or card or in an enclosed leaflet, this information shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.

4.   For cosmetic products that are not pre-packaged, are packaged at the point of sale at the purchaser's request, or are pre-packaged for immediate sale, Member States shall adopt detailed rules for indication of the information referred to in paragraph 1.

5.   The language of the information mentioned in points (b), (c), (d) and (f) of paragraph 1 and in paragraphs (2), (3) and (4) shall be determined by the law of the Member States in which the product is made available to the end user.

6.   The information mentioned in point (g) of paragraph 1 shall be expressed by using the common ingredient name set out in the glossary provided for in Article 33. In the absence of a common ingredient name, a term as contained in a generally accepted nomenclature shall be used.

Article 20

Product claims

1.   In the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.

2.   The Commission shall, in cooperation with Member States, establish an action plan regarding claims used and fix priorities for determining common criteria justifying the use of a claim.

After consulting the SCCS or other relevant authorities, the Commission shall adopt a list of common criteria for claims which may be used in respect of cosmetic products, in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation, taking into account the provisions of Directive 2005/29/EC.

By 11 July 2016, the Commission shall submit to the European Parliament and the Council a report regarding the use of claims on the basis of the common criteria adopted under the second subparagraph. If the report concludes that claims used in respect of cosmetic products are not in conformity with the common criteria, the Commission shall take appropriate measures to ensure compliance in cooperation with the Member States.

3.   The responsible person may refer, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the cosmetic product, to the fact that no animal tests have been carried out only if the manufacturer and his suppliers have not carried out or commissioned any animal tests on the finished cosmetic product, or its prototype, or any of the ingredients contained in it, or used any ingredients that have been tested on animals by others for the purpose of developing new cosmetic products.

Article 21

Access to information for the public

Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, the responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product are made easily accessible to the public by any appropriate means.

The quantitative information regarding composition of the cosmetic product required to be made publicly accessible shall be limited to hazardous substances in accordance with Article 3 of Regulation (EC) No 1272/2008.

CHAPTER VII

MARKET SURVEILLANCE

Article 22

In-market control

Member States shall monitor compliance with this Regulation via in-market controls of the cosmetic products made available on the market. They shall perform appropriate checks of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples.

Member States shall also monitor compliance with the principles of good manufacturing practices.

Member States shall entrust to market surveillance authorities the necessary powers, resources and knowledge in order for those authorities to properly perform their tasks.

Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission and be made available to the public, by way of electronic communication and, where appropriate, by other means.

Article 23

Communication of serious undesirable effects

1.   In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred:

(a)

all serious undesirable effects which are known to him or which may reasonably be expected to be known to him;

(b)

the name of the cosmetic product concerned, enabling its specific identification;

(c)

the corrective measures taken by him, if any.

2.   Where the responsible person reports serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member States.

3.   Where distributors report serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member States and to the responsible person.

4.   Where end users or health professionals report serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information on the cosmetic product concerned to the competent authorities of the other Member States and to the responsible person.

5.   Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.

Article 24

Information on substances

In the event of serious doubt regarding the safety of any substance contained in cosmetic products, the competent authority of a Member State in which a product containing such a substance is made available on the market may by reasoned request require the responsible person to submit a list of all cosmetic products for which he is responsible and which contain this substance. The list shall indicate the concentration of this substance in the cosmetic products.

Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.

CHAPTER VIII

NON-COMPLIANCE, SAFEGUARD CLAUSE

Article 25

Non-compliance by the responsible person

1.   Without prejudice to paragraph 4, competent authorities shall require the responsible person to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or its recall, within an expressly mentioned time limit, commensurate with the nature of the risk, where there is non-compliance with any of the following:

(a)

the good manufacturing practice referred to in Article 8;

(b)

the safety assessment referred to in Article 10;

(c)

the requirements for the product information file referred to in Article 11;

(d)

the provisions on sampling and analysis referred to in Article 12;

(e)

the notification requirements referred to in Articles 13 and 16;

(f)

the restrictions for substances referred to in Articles 14, 15 and 17;

(g)

the animal testing requirements referred to in Article 18;

(h)

the labelling requirements referred to in Article 19(1), (2), (5) and (6);

(i)

the requirements related to product claims set out in Article 20;

(j)

the access to information for the public referred to in Article 21;

(k)

the communication of serious undesirable effects referred to in Article 23;

(l)

the information requirements on substances referred to in Article 24.

2.   Where applicable, a competent authority shall inform the competent authority of the Member State in which the responsible person is established of the measures which it has required the responsible person to take.

3.   The responsible person shall ensure that the measures referred to in paragraph 1 are taken in respect of all the products concerned which are made available on the market throughout the Community.

4.   In the case of serious risks to human health, where the competent authority considers that the non-compliance is not limited to the territory of the Member State in which the cosmetic product is made available on the market, it shall inform the Commission and the competent authorities of the other Member States of the measures which it has required the responsible person to take.

5.   The competent authority shall take all appropriate measures to prohibit or restrict the making available on the market of the cosmetic product or to withdraw the product from the market or to recall it in the following cases:

(a)

where an immediate action is necessary in the event of serious risk to human health; or

(b)

where the responsible person does not take all appropriate measures within the time limit referred to in paragraph 1.

In the event of serious risks to human health, that competent authority shall inform the Commission and the competent authorities of the other Member States, without delay, of the measures taken.

6.   In the absence of a serious risk to human health, in the event that the responsible person does not take all appropriate measures, the competent authority shall without delay inform the competent authority of the Member State in which the responsible person is established of the measures taken.

7.   For the purposes of paragraphs 4 and 5 of this Article, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (16) shall be used.

Article 12(2), (3) and (4) of Directive 2001/95/EC and Article 23 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (17) shall also apply.

Article 26

Non-compliance by distributors

Competent authorities shall require distributors to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or its recall, within a given reasonable time limit, commensurate with the nature of the risk, where there is non-compliance with obligations laid down in Article 6.

Article 27

Safeguard clause

1.   In the case of products meeting the requirements listed in Article 25(1), where a competent authority ascertains, or has reasonable grounds for concern, that a cosmetic product or products made available on the market present or could present a serious risk to human health, it shall take all appropriate provisional measures in order to ensure that the product or products concerned are withdrawn, recalled or their availability is otherwise restricted.

2.   The competent authority shall immediately communicate to the Commission and the competent authorities of the other Member States the measures taken and any supporting data.

For the purposes of the first subparagraph, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC shall be used.

Article 12(2), (3) and (4) of Directive 2001/95/EC shall apply.

3.   The Commission shall determine, as soon as possible, whether the provisional measures referred to in paragraph 1 are justified or not. For that purpose it shall, whenever possible, consult the interested parties, the Member States and the SCCS.

4.   Where the provisional measures are justified, Article 31(1) shall apply.

5.   Where the provisional measures are not justified the Commission shall inform the Member States thereof and the competent authority concerned shall repeal the provisional measures in question.

Article 28

Good administrative practices

1.   Any decision taken pursuant to Articles 25 and 27 shall state the exact grounds on which it is based. It shall be notified by the competent authority without delay to the responsible person, who shall at the same time be informed of the remedies available to him under the law of the Member State concerned and of the time limits to which remedies are subject.

2.   Except in the case where immediate action is necessary for reasons of serious risk to human health, the responsible person shall have the opportunity to put forward his viewpoint before any decision is taken.

3.   Where applicable, the provisions mentioned in paragraphs 1 and 2 shall apply with regard to the distributor for any decisions taken pursuant to Articles 26 and 27.

CHAPTER IX

ADMINISTRATIVE COOPERATION

Article 29

Cooperation between competent authorities

1.   The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure the proper application and due enforcement of this Regulation and shall transmit to each other all information necessary with a view to applying this Regulation uniformly.

2.   The Commission shall provide for the organisation of an exchange of experience between the competent authorities in order to coordinate the uniform application of this Regulation.

3.   Cooperation may be part of initiatives developed at international level.

Article 30

Cooperation regarding verification of product information files

The competent authority of any Member State where the cosmetic product is made available may request the competent authority of the Member State where the product information file is made readily accessible to verify whether the product information file satisfies the requirements referred to in Article 11(2) and whether the information set out therein provides evidence of the safety of the cosmetic product.

The requesting competent authority shall provide a motivation for the request.

Upon that request, the competent authority requested shall, without undue delay and taking into account the degree of urgency, carry out the verification and shall inform the requesting competent authority of its findings.

CHAPTER X

IMPLEMENTING MEASURES, FINAL PROVISIONS

Article 31

Amendment of the Annexes

1.   Where there is a potential risk to human health, arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis, the Commission may, after consulting the SCCS, amend Annexes II to VI accordingly.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4).

2.   The Commission may, after consulting the SCCS, amend Annexes III to VI and VIII for the purposes of adapting them to technical and scientific progress.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

3.   Where it appears necessary, in order to ensure the safety of cosmetic products placed on the market, the Commission may, after consulting the SCCS, amend Annex I.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

Article 32

Committee procedure

1.   The Commission shall be assisted by the Standing Committee on Cosmetic Products.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply having regard to the provisions of Article 8 thereof.

Article 33

Glossary of common ingredient names

The Commission shall compile and update a glossary of common ingredient names. To this end, the Commission shall take account of internationally recognised nomenclatures including the International Nomenclature of Cosmetic Ingredients (INCI). That glossary shall not constitute a list of the substances authorised for use in cosmetic products.

The common ingredient name shall be applied for the purpose of labelling cosmetic products placed on the market at the latest twelve months after publication of the glossary in the Official Journal of the European Union.

Article 34

Competent authorities, poison control centres or assimilated entities

1.   Member States shall designate their national competent authorities.

2.   Member States shall communicate the details of authorities referred to in paragraph 1 and of the poison centres and similar bodies referred to in Article 13(6) to the Commission. They shall communicate an update of these details as necessary.

3.   The Commission shall compile and update a list of the authorities and bodies referred to in paragraph 2 and make it available to the public.

Article 35

Annual report on animal testing

Every year the Commission shall present a report to the European Parliament and the Council on:

(1)

progress made in the development, validation and legal acceptance of alternative methods. The report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Directive 86/609/EEC. The Commission shall in particular ensure the development, validation and legal acceptance of alternative test methods which do not use live animals;

(2)

progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by third countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries;

(3)

the manner in which the specific needs of small and medium-sized enterprises have been taken into account.

Article 36

Formal objection against harmonised standards

1.   When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements set out in the relevant provisions of this Regulation, the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, giving its arguments. The Committee shall deliver its opinion without delay.

2.   In the light of the Committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.

3.   The Commission shall inform the Member States and the European standardisation body concerned. It shall, if necessary, request the revision of the harmonised standards concerned.

Article 37

Penalties

Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 11 July 2013 and shall notify it without delay of any subsequent amendment affecting them.

Article 38

Repeal

Directive 76/768/EEC is repealed with effect from 11 July 2013, with the exception of Article 4b which is repealed with effect from 1 December 2010.

References to the repealed Directive shall be understood as references to this Regulation.

This Regulation shall be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex IX.

However, the competent authorities shall continue to keep available the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC and responsible persons shall continue to keep readily accessible the information collected pursuant to Article 7a of that Directive until 11 July 2020.

Article 39

Transitional provisions

By way of derogation from Directive 76/768/EEC, cosmetic products which comply with this Regulation may be placed on the market before 11 July 2013.

As from 11 January 2012, by way of derogation from Directive 76/768/EEC, notification carried out in accordance with Article 13 of this Regulation shall be considered to comply with Article 7(3) and Article 7a(4) of that Directive.

Article 40

Entry into force and date of application

1.   This Regulation shall enter into force on the [twentieth day after its publication in the Official Journal of the European Union

2.   It shall apply from 11 July 2013, with the exception of:

Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and

Article 16(3) second subparagraph, which shall apply from 11 January 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 November 2009.

For the European Parliament

The President

J. BUZEK

For the Council

The President

B. ASK


(1)  OJ C 27, 3.2.2009, p. 34.

(2)  Opinion of the European Parliament of 24 March 2009 (not yet published in the Official Journal) and Council Decision of 20 November 2009.

(3)  OJ L 262, 27.9.1976, p. 169.

(4)  OJ L 396, 30.12.2006, p. 1.

(5)  OJ L 192, 11.7.1987, p. 49.

(6)  OJ L 196, 2.8.2003, p. 7.

(7)  OJ L 157, 30.4.2004, p. 45.

(8)  OJ L 241, 10.9.2008, p. 21.

(9)  OJ L 353, 31.12.2008, p. 1.

(10)  OJ L 358, 18.12.1986, p. 1.

(11)  OJ L 149, 11.6.2005, p. 22.

(12)  OJ L 184, 17.7.1999, p. 23.

(13)  OJ L 204, 21.7.1998, p. 37.

(14)  OJ L 31, 1.2.2002, p. 1.

(15)  OJ L 142, 31.5.2008, p. 1.

(16)  OJ L 11, 15.1.2002, p. 4.

(17)  OJ L 218, 13.8.2008, p. 30.


ANNEX I

COSMETIC PRODUCT SAFETY REPORT

The cosmetic product safety report shall, as a minimum, contain the following:

PART A –   Cosmetic product safety information

1.   Quantitative and qualitative composition of the cosmetic product

The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. In the case of perfume and aromatic compositions, description of the name and code number of the composition and the identity of the supplier.

2.   Physical/chemical characteristics and stability of the cosmetic product

The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product.

The stability of the cosmetics product under reasonably foreseeable storage conditions.

3.   Microbiological quality

The microbiological specifications of the substance or mixture and the cosmetic product. Particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing compromised immune responses.

Results of preservation challenge test.

4.   Impurities, traces, information about the packaging material

The purity of the substances and mixtures.

In the case of traces of prohibited substances, evidence for their technical unavoidability.

The relevant characteristics of packaging material, in particular purity and stability.

5.   Normal and reasonably foreseeable use

The normal and reasonably foreseeable use of the product. The reasoning shall be justified in particular in the light of warnings and other explanations in the product labelling.

6.   Exposure to the cosmetic product

Data on the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to

1)

The site(s) of application;

2)

The surface area(s) of application;

3)

The amount of product applied;

4)

The duration and frequency of use;

5)

The normal and reasonably foreseeable exposure route(s);

6)

The targeted (or exposed) population(s). Potential exposure of a specific population shall also be taken into account.

The calculation of the exposure shall also take into consideration the toxicological effects to be considered (e.g. exposure might need to be calculated per unit area of skin or per unit of body weight). The possibility of secondary exposure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalation of sprays, non-intended ingestion of lip products, etc.).

Particular consideration shall be given to any possible impacts on exposure due to particle sizes.

7.   Exposure to the substances

Data on the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6.

8.   Toxicological profile of the substances

Without prejudice to Article 18, the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made.

All significant toxicological routes of absorption shall be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL) shall be calculated. The absence of these considerations shall be duly justified.

Particular consideration shall be given to any possible impacts on the toxicological profile due to

particle sizes, including nanomaterials,

impurities of the substances and raw material used, and

interaction of substances.

Any read-across shall be duly substantiated and justified.

The source of information shall be clearly identified.

9.   Undesirable effects and serious undesirable effects

All available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products. This includes statistical data.

10.   Information on the cosmetic product

Other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas.

PART B –   Cosmetic product safety assessment

1.   Assessment conclusion

Statement on the safety of the cosmetic product in relation to Article 3.

2.   Labelled warnings and instructions of use

Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d).

3.   Reasoning

Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2. This explanation shall be based on the descriptions set out under Part A. Where relevant, margins of safety shall be assessed and discussed.

There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.

Possible interactions of the substances contained in the cosmetic product shall be assessed.

The consideration and non-consideration of the different toxicological profiles shall be duly justified.

Impacts of the stability on the safety of the cosmetic product shall be duly considered.

4.   Assessor's credentials and approval of part B

Name and address of the safety assessor.

Proof of qualification of safety assessor.

Date and signature of safety assessor.


Preamble to Annexes II to VI

(1)

For the purposes of the Annexes II to VI:

(a)

‘Rinse-off product’ means a cosmetic product which is intended to be removed after application on the skin, the hair or the mucous membranes;

(b)

‘Leave-on product’ means a cosmetic product which is intended to stay in prolonged contact with the skin, the hair or the mucous membranes;

(c)

‘Hair product’ means a cosmetic product which is intended to be applied on the hair of head or face, except eye lashes;

(d)

‘Skin product’ means a cosmetic product which is intended to be applied on the skin;

(e)

‘Lip product’ means a cosmetic product which is intended to be applied on the lips;

(f)

‘Face product’ means a cosmetic product which is intended to be applied on the skin of the face;

(g)

‘Nail product’ means a cosmetic product which is intended to be applied on nails;

(h)

‘Oral product’ means a cosmetic product which is intended to be applied on teeth or the mucous membranes of the oral cavity;

(i)

‘Product applied on mucous membranes’ means a cosmetic product which is intended to be applied on the mucous membranes

of the oral cavity,

on the rim of the eyes,

or of the external genital organs;

(j)

‘Eye product’ means a cosmetic product which is intended to be applied in the vicinity of the eyes;

(k)

‘Professional use’ means the application and use of cosmetic products by persons in the exercise of their professional activity.

(2)

In order to facilitate substance identification, the following descriptors are used:

The Non-proprietary Names (INN) for pharmaceutical products, WHO, Geneva, August 1975;

The Chemical Abstracts Service numbers (CAS);

The EC number which correspond to either the European Inventory of Existing Commercial chemical Substances (EINECS) numbers or the European List of Notified Chemical Substances (ELINCS) numbers or the registration number given under Regulation (EC) No 1907/2006;

The XAN which is the name approved by specific country (X), e.g. USAN which correspond to the United State approved name;

The name in the glossary of common ingredient names referred to in Article 33 of this Regulation.

(3)

Substances listed in Annexes III to VI do not cover nanomaterials, except where specifically mentioned.


ANNEX II

LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

a

b

c

d

1

N-(5-Chlorobenzoxazol-2-yl)acetamide

35783-57-4

 

2

(2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its salts

51-84-3

200-128-9

3

Deanol aceglumate (INN)

3342-61-8

222-085-5

4

Spironolactone (INN)

52-01-7

200-133-6

5

[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid (Tiratricol (INN)) and its salts

51-24-1

200-086-1

6

Methotrexate (INN)

59-05-2

200-413-8

7

Aminocaproic acid (INN) and its salts

60-32-2

200-469-3

8

Cinchophen (INN), its salts, derivatives and salts of these derivatives

132-60-5

205-067-1

9

Thyropropic acid (INN) and its salts

51-26-3

 

10

Trichloroacetic acid

76-03-9

200-927-2

11

Aconitum napellus L. (leaves, roots and galenical preparations)

84603-50-9

283-252-6

12

Aconitine (principal alkaloid of Aconitum napellus L.) and its salts

302-27-2

206-121-7

13

Adonis vernalis L. and its preparations

84649-73-0

283-458-6

14

Epinephrine (INN)

51-43-4

200-098-7

15

Rauwolfia serpentina L., alkaloids and their salts

90106-13-1

290-234-1

16

Alkyne alcohols, their esters, ethers and salts

 

 

17

Isoprenaline (INN)

7683-59-2

231-687-7

18

Allyl isothiocyanate

57-06-7

200-309-2

19

Alloclamide (INN) and its salts

5486-77-1

 

20

Nalorphine (INN), its salts and ethers

62-67-9

200-546-1

21

Sympathicomimetic amines acting on the central nervous system: any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe

300-62-9

206-096-2

22

Aniline, its salts and its halogenated and sulphonated derivatives

62-53-3

200-539-3

23

Betoxycaine (INN) and its salts

3818-62-0

 

24

Zoxazolamine (INN)

61-80-3

200-519-4

25

Procainamide (INN), its salts and derivatives

51-06-9

200-078-8

26

Benzidine

92-87-5

202-199-1

27

Tuaminoheptane (INN), its isomers and salts

123-82-0

204-655-5

28

Octodrine (INN) and its salts

543-82-8

208-851-1

29

2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts

530-34-7

 

30

1,3-Dimethylpentylamine and its salts

105-41-9

203-296-1

31

4-Aminosalicylic acid and its salts

65-49-6

200-613-5

32

Toluidines, their isomers, salts and halogenated and sulphonated derivatives

26915-12-8

248-105-2

33

Xylidines, their isomers, salts and halogenated and sulphonated derivatives

1300-73-8

215-091-4

34

Imperatorin (9-(3-methylbut-2-enyloxy)furo[3,2-g]chromen-7-one)

482-44-0

207-581-1

35

Ammi majus L. and its galenical preparations

90320-46-0

291-072-4

36

2,3-Dichloro-2-methylbutane

507-45-9

 

37

Substances with androgenic effect

 

 

38

Anthracene oil

120-12-7

204-371-1

39

Antibiotics

 

 

40

Antimony and its compounds

7440-36-0

231-146-5

41

Apocynum cannabinum L. and its preparations

84603-51-0

283-253-1

42

Apomorphine ((R) 5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol) and its salts

58-00-4

200-360-0

43

Arsenic and its compounds

7440-38-2

231-148-6

44

Atropa belladonna L. and its preparations

8007-93-0

232-365-9

45

Atropine, its salts and derivatives

51-55-8

200-104-8

46

Barium salts, with the exception of barium sulphide under the conditions laid down in Annex III, and of barium sulfate, lakes, salts and pigments prepared from colouring agents when listed in Annex IV

 

 

47

Benzene

71-43-2

200-753-7

48

Benzimidazol-2(3H)-one

615-16-7

210-412-4

49

Benzazepines and benzodiazepines

12794-10-4

 

50

1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts

644-26-8

211-411-1

51

2,2,6-Trimethyl-4-piperidyl benzoate (eucaine) and its salts

500-34-5

 

52

Isocarboxazid (INN)

59-63-2

200-438-4

53

Bendroflumethiazide (INN) and its derivatives

73-48-3

200-800-1

54

Beryllium and its compounds

7440-41-7

231-150-7

55

Bromine, elemental

7726-95-6

231-778-1

56

Bretylium tosilate (INN)

61-75-6

200-516-8

57

Carbromal (INN)

77-65-6

201-046-6

58

Bromisoval (INN)

496-67-3

207-825-7

59

Brompheniramine (INN) and its salts

86-22-6

201-657-8

60

Benzilonium bromide (INN)

1050-48-2

213-885-5

61

Tetrylammonium bromide (INN)

71-91-0

200-769-4

62

Brucine

357-57-3

206-614-7

63

Tetracaine (INN) and its salts

94-24-6

202-316-6

64

Mofebutazone (INN)

2210-63-1

218-641-1

65

Tolbutamide (INN)

64-77-7

200-594-3

66

Carbutamide (INN)

339-43-5

206-424-4

67

Phenylbutazone (INN)

50-33-9

200-029-0

68

Cadmium and its compounds

7440-43-9

231-152-8

69

Cantharides, Cantharis vesicatoria

92457-17-5

296-298-7

70

Cantharidine

56-25-7

200-263-3

71

Phenprobamate (INN)

673-31-4

211-606-1

72

Nitroderivatives of carbazole

 

 

73

Carbon disulphide

75-15-0

200-843-6

74

Catalase

9001-05-2

232-577-1

75

Cephaeline and its salts

483-17-0

207-591-6

76

Chenopodium ambrosioides L. (essential oil)

8006-99-3

 

77

2,2,2-Trichloroethane-1,1-diol

302-17-0

206-117-5

78

Chlorine

7782-50-5

231-959-5

79

Chlorpropamide (INN)

94-20-2

202-314-5

80

Moved or deleted

 

 

81

4-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride)

5909-04-6

 

82

Chlorzoxazone (INN)

95-25-0

202-403-9

83

2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)

535-89-7

208-622-6

84

Chlorprothixene (INN) and its salts

113-59-7

204-032-8

85

Clofenamide (INN)

671-95-4

211-588-5

86

N,N-bis(2-chloroethyl)methylamine N-oxide and its salts

126-85-2

 

87

Chlormethine (INN) and its salts

51-75-2

200-120-5

88

Cyclophosphamide (INN) and its salts

50-18-0

200-015-4

89

Mannomustine (INN) and its salts

576-68-1

209-404-3

90

Butanilicaine (INN) and its salts

3785-21-5

 

91

Chlormezanone (INN)

80-77-3

201-307-4

92

Triparanol (INN)

78-41-1

201-115-0

93

2-[2(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione (chlorophacinone-ISO)

3691-35-8

223-003-0

94

Chlorphenoxamine (INN)

77-38-3

 

95

Phenaglycodol (INN)

79-93-6

201-235-3

96

Chloroethane

75-00-3

200-830-5

97

Chromium; chromic acid and its salts

7440-47-3

231-157-5

98

Claviceps purpurea Tul., its alkaloids and galenical preparations

84775-56-4

283-885-8

99

Conium maculatum L. (fruit, powder, galenical preparations)

85116-75-2

285-527-6

100

Glycyclamide (INN)

664-95-9

211-557-6

101

Cobalt benzenesulphonate

23384-69-2

 

102

Colchicine, its salts and derivatives

64-86-8

200-598-5

103

Colchicoside and its derivatives

477-29-2

207-513-0

104

Colchicum autumnale L. and its galenical preparations

84696-03-7

283-623-2

105

Convallatoxin

508-75-8

208-086-3

106

Anamirta cocculus L. (fruit)

 

 

107

Croton tiglium L. (oil)

8001-28-3

 

108

1-Butyl-3-(N-crotonoylsulphanilyl)urea

52964-42-8

 

109

Curare and curarine

8063-06-7/22260-42-0

232-511-1/244-880-6

110

Synthetic curarizants

 

 

111

Hydrogen cyanide and its salts

74-90-8

200-821-6

112

Feclemine (INN); 2-(alpha-Cyclohexylbenzyl)-N,N,N',N'-tetraethyl-1,3-propanediamine

3590-16-7

 

113

Cyclomenol (INN) and its salts

5591-47-9

227-002-6

114

Sodium hexacyclonate (INN)

7009-49-6

 

115

Hexapropymate (INN)

358-52-1

206-618-9

116

Moved or deleted

 

 

117

O,O'-Diacetyl-N-allyl-N-normorphine

2748-74-5

 

118

Pipazetate (INN) and its salts

2167-85-3

218-508-8

119

5-(α,β-Dibromophenethyl)-5-methylhydantoin

511-75-1

208-133-8

120

N,N'-Pentamethylenebis(trimethylammonium) salts, e. g. pentamethonium bromide (INN)

541-20-8

208-771-7

121

N,N'-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e. g. azamethonium bromide (INN)

306-53-6

206-186-1

122

Cyclarbamate (INN)

5779-54-4

227-302-7

123

Clofenotane (INN); DDT (ISO)

50-29-3

200-024-3

124

N,N'-Hexamethylenebis(trimethylammonium) salts, e. g. hexamethonium bromide (INN)

55-97-0

200-249-7

125

Dichloroethanes (ethylene chlorides) e.g. 1,2-Dichloroethane

107-06-2

203-458-1

126

Dichloroethylenes (acetylene chlorides) e.g. Vinylidene chloride (1,1-Dichloroethylene)

75-35-4

200-864-0

127

Lysergide (INN) (LSD) and its salts

50-37-3

200-033-2

128

2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts

3572-52-9

222-686-2

129

Cinchocaine (INN) and its salts

85-79-0

201-632-1

130

3-Diethylaminopropyl cinnamate

538-66-9

 

131

O,O'-Diethyl-O-4-nitrophenyl phosphorothioate (Parathion - ISO)

56-38-2

200-271-7

132

[Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts, e. g. ambenonium chloride (INN)

115-79-7

204-107-5

133

Methyprylon (INN) and its salts

125-64-4

204-745-4

134

Digitaline and all heterosides of Digitalis purpurea L.

752-61-4

212-036-6

135

7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline (xanthinol)

2530-97-4

 

136

Dioxethedrin (INN) and its salts

497-75-6

207-849-8

137

Piprocurarium iodide (INN)

3562-55-8

222-627-0

138

Propyphenazone (INN)

479-92-5

207-539-2

139

Tetrabenazine (INN) and its salts

58-46-8

200-383-6

140

Captodiame (INN)

486-17-9

207-629-1

141

Mefeclorazine (INN) and its salts

1243-33-0

 

142

Dimethylamine

124-40-3

204-697-4

143

1,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine, alypine) and its salts

963-07-5

213-512-6

144

Methapyrilene (INN) and its salts

91-80-5

202-099-8

145

Metamfepramone (INN) and its salts

15351-09-4

239-384-1

146

Amitriptyline (INN) and its salts

50-48-6

200-041-6

147

Metformin (INN) and its salts

657-24-9

211-517-8

148

Isosorbide dinitrate (INN)

87-33-2

201-740-9

149

Malononitrile

109-77-3

203-703-2

150

Succinonitrile

110-61-2

203-783-9

151

Dinitrophenol isomers

51-28-5/329-71-5/573-56-8/25550-58-7

200-087-7/206-348-1/209-357-9/247-096-2

152

Inproquone (INN)

436-40-8

 

153

Dimevamide (INN) and its salts

60-46-8

200-479-8

154

Diphenylpyraline (INN) and its salts

147-20-6

205-686-7

155

Sulfinpyrazone (INN)

57-96-5

200-357-4

156

N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethyl-ammonium salts, e. g. isopropamide iodide (INN)

71-81-8

200-766-8

157

Benactyzine (INN)

302-40-9

206-123-8

158

Benzatropine (INN) and its salts

86-13-5

 

159

Cyclizine (INN) and its salts

82-92-8

201-445-5

160

5,5-Diphenyl-4-imidazolidone (Doxenitoin (INN))

3254-93-1

221-851-6

161

Probenecid (INN)

57-66-9

200-344-3

162

Disulfiram (INN); thiram (INN)

97-77-8/137-26-8

202-607-8/205-286-2

163

Emetine, its salts and derivatives

483-18-1

207-592-1

164

Ephedrine and its salts

299-42-3

206-080-5

165

Oxanamide (INN) and its derivatives

126-93-2

 

166

Eserine or physostigmine and its salts

57-47-6

200-332-8

167

Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Annex VI

 

 

168

Choline salts and their esters, e. g. choline chloride (INN)

67-48-1

200-655-4

169

Caramiphen (INN) and its salts

77-22-5

201-013-6

170

Diethyl 4-nitrophenyl phosphate (Paraoxon - ISO)

311-45-5

206-221-0

171

Metethoheptazine (INN) and its salts

509-84-2

 

172

Oxpheneridine (INN) and its salts

546-32-7

 

173

Ethoheptazine (INN) and its salts

77-15-6

201-007-3

174

Metheptazine (INN) and its salts

469-78-3

 

175

Methylphenidate (INN) and its salts

113-45-1

204-028-6

176

Doxylamine (INN) and its salts

469-21-6

207-414-2

177

Tolboxane (INN)

2430-46-8

 

178

4-Benzyloxyphenol and 4-ethoxyphenol

103-16-2/622-62-8

203-083-3/210-748-1

179

Parethoxycaine (INN) and its salts

94-23-5

205-246-4

180

Fenozolone (INN)

15302-16-6

239-339-6

181

Glutethimide (INN) and its salts

77-21-4

201-012-0

182

Ethylene oxide

75-21-8

200-849-9

183

Bemegride (INN) and its salts

64-65-3

200-588-0

184

Valnoctamide (INN)

4171-13-5

224-033-7

185

Haloperidol (INN)

52-86-8

200-155-6

186

Paramethasone (INN)

53-33-8

200-169-2

187

Fluanisone (INN)

1480-19-9

216-038-8

188

Trifluperidol (INN)

749-13-3

 

189

Fluoresone (INN)

2924-67-6

220-889-0

190

Fluorouracil (INN)

51-21-8

200-085-6

191

Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III

7664-39-3

231-634-8

192

Furfuryltrimethylammonium salts, e. g. furtrethonium iodide (INN)

541-64-0

208-789-5

193

Galantamine (INN)

357-70-0

 

194

Progestogens

 

 

195

1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)

58-89-9

200-401-2

196

(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8-dimethano-naphthalene (endrin-ISO)

72-20-8

200-775-7

197

Hexachloroethane

67-72-1

200-666-4

198

(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene (isodrin-ISO)

465-73-6

207-366-2

199

Hydrastine, hydrastinine and their salts

118-08-1/6592-85-4

204-233-0/229-533-9

200

Hydrazides and their salts e.g. Isoniazid (INN)

54-85-3

200-214-6

201

Hydrazine, its derivatives and their salts

302-01-2

206-114-9

202

Octamoxin (INN) and its salts

4684-87-1

 

203

Warfarin (INN) and its salts

81-81-2

201-377-6

204

Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid

548-00-5

208-940-5

205

Methocarbamol (INN)

532-03-6

208-524-3

206

Propatylnitrate (INN)

2921-92-8

220-866-5

207

4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin

 

 

208

Fenadiazole (INN)

1008-65-7

 

209

Nitroxoline (INN) and its salts

4008-48-4

223-662-4

210

Hyoscyamine, its salts and derivatives

101-31-5

202-933-0

211

Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)

84603-65-6

283-265-7

212

Pemoline (INN) and its salts

2152-34-3

218-438-8

213

Iodine

7553-56-2

231-442-4

214

Decamethylenebis(trimethylammonium) salts, e. g. decamethonium bromide (INN)

541-22-0

208-772-2

215

Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)

8012-96-2

232-385-8

216

(2-Isopropylpent4-enoyl)urea (apronalide)