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Document 02010R0066-20171114
Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (Text with EEA relevance)
Consolidated text: Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (Text with EEA relevance)
Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (Text with EEA relevance)
02010R0066 — EN — 14.11.2017 — 002.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
REGULATION (EC) No 66/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2009 on the EU Ecolabel (OJ L 027 30.1.2010, p. 1) |
Amended by:
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Official Journal |
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No |
page |
date |
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L 219 |
26 |
15.8.2013 |
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L 275 |
9 |
25.10.2017 |
Corrected by:
REGULATION (EC) No 66/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 25 November 2009
on the EU Ecolabel
(Text with EEA relevance)
Article 1
Subject matter
This Regulation lays down rules for the establishment and application of the voluntary EU Ecolabel scheme.
Article 2
Scope
Article 3
Definitions
For the purposes of this Regulation, the following definitions shall apply:
‘product group’ means a set of products that serve similar purposes and are similar in terms of use, or have similar functional properties, and are similar in terms of consumer perception;
‘operator’ means any producer, manufacturer, importer, service provider, wholesaler or retailer;
‘environmental impact’ means any change to the environment resulting wholly or partially from a product during its life cycle;
‘environmental performance’ means the result of a manufacturer's management of those characteristics of a product that cause environmental impact;
‘verification’ means a procedure to certify that a product complies with specified EU Ecolabel criteria.
Article 4
Competent bodies
Article 5
European Union Ecolabelling Board
Article 6
General requirements for EU Ecolabel criteria
EU Ecolabel criteria shall be determined on a scientific basis considering the whole life cycle of products. In determining such criteria, the following shall be considered:
the most significant environmental impacts, in particular the impact on climate change, the impact on nature and biodiversity, energy and resource consumption, generation of waste, emissions to all environmental media, pollution through physical effects and use and release of hazardous substances;
the substitution of hazardous substances by safer substances, as such or via the use of alternative materials or designs, wherever it is technically feasible;
the potential to reduce environmental impacts due to durability and reusability of products;
the net environmental balance between the environmental benefits and burdens, including health and safety aspects, at the various life stages of the products;
where appropriate, social and ethical aspects, e.g. by making reference to related international conventions and agreements such as relevant ILO standards and codes of conduct;
criteria established for other environmental labels, particularly officially recognised, nationally or regionally, EN ISO 14024 type I environmental labels, where they exist for that product group so as to enhance synergies;
as far as possible the principle of reducing animal testing.
Before developing EU Ecolabel criteria for food and feed products, 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 ( 3 ), the Commission shall undertake a study, by 31 December 2011 at the latest, exploring the feasibility of establishing reliable criteria covering environmental performance during the whole life cycle of such products, including the products of fishing and aquaculture. The study should pay particular attention to the impact of any EU Ecolabel criteria on food and feed products, as well as unprocessed agricultural products that lie within the scope of Regulation (EC) No 834/2007. The study should consider the option that only those products certified as organic would be eligible for award of the EU Ecolabel, to avoid confusion for consumers.
The Commission shall decide, taking into account the outcome of the study and the opinion of the EUEB, for which group of food and feed, if any, the development of EU Ecolabel criteria is feasible, in accordance with the regulatory procedure with scrutiny referred to in Article 16(2).
Article 7
Development and revision of EU Ecolabel criteria
Following consultation of the EUEB, the Commission, Member States, competent bodies and other stakeholders may initiate and lead the development or revision of EU Ecolabel criteria. Where such other stakeholders are put in charge of leading the development of criteria, they must demonstrate expertise in the product area, as well as the ability to lead the process with neutrality and in line with the aims of this Regulation. In this regard, consortiums consisting of more than one interest group shall be favoured.
The party which initiates and leads the development or revision of EU Ecolabel criteria shall, in accordance with the procedure set out in Part A of Annex I, produce the following documents:
a preliminary report;
a proposal for draft criteria;
a technical report in support of the proposal for draft criteria;
a final report;
a manual for potential users of the EU Ecolabel and competent bodies;
a manual for authorities awarding public contracts.
Those documents shall be submitted to the Commission and to the EUEB.
Where criteria have already been developed under another ecolabel scheme complying with the requirements of EN ISO 14024 type I environmental labels for a product group for which no EU Ecolabel criteria have been established, any Member State in which the other ecolabel scheme is recognised may, after consulting the Commission and the EUEB, propose those criteria for development under the EU Ecolabel scheme.
In such cases, the shortened criteria development procedure laid down in Part B of Annex I may apply provided that the proposed criteria have been developed in line with Part A of Annex I. Either the Commission or the Member State which, according to the first subparagraph, has proposed the shortened criteria development procedure shall lead that procedure.
Article 8
Establishment of EU Ecolabel criteria
The Commission shall, no later than nine months after consulting the EUEB, adopt measures to establish specific EU Ecolabel criteria for each product group. These measures shall be published in the Official Journal of the European Union.
In its final proposal, the Commission shall take into account the comments of the EUEB and shall clearly highlight, document and provide explanations for the reasoning behind any changes in its final proposal compared to the proposal for draft criteria following the consultation of the EUEB.
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 16(2).
In the measures referred to in paragraph 2 the Commission shall:
establish requirements for assessing the compliance of specific products with EU Ecolabel criteria (‘assessment requirements’);
specify, for each product group, three key environmental characteristics that may be displayed in the optional label with text box described in Annex II;
specify, for each product group, the relevant period of validity of the criteria and of the assessment requirements;
specify the degree of product variability allowed during the period of validity referred to in point (c).
Article 9
Award of the EU Ecolabel and terms and conditions of its use
Any operator who wishes to use the EU Ecolabel shall apply to the competent bodies referred to in Article 4 in accordance with the following rules:
where a product originates in a single Member State, the application shall be presented to a competent body of that Member State;
where a product originates in the same form in several Member States, the application may be presented to a competent body in one of those Member States;
where a product originates outside the Community, the application shall be presented to a competent body in any of the Member States in which the product is to be or has been placed on the market.
The EU Ecolabel shall have the form depicted in Annex II.
The EU Ecolabel may only be used in connection with products complying with the EU Ecolabel criteria applicable to the products concerned and for which the EU Ecolabel has been awarded.
Applications shall specify the full contact details of the operator, as well as the product group in question and shall contain a full description of the product as well as all other information requested by the competent body.
Applications shall include all relevant documentation, as specified in the relevant Commission measure establishing EU Ecolabel criteria for the product group in question.
Within two months of receipt of an application, the competent body concerned shall check whether the documentation is complete and shall notify the operator. The competent body may reject the application if the operator fails to complete the documentation within six months after such notification.
Provided that the documentation is complete and the competent body has verified that the product complies with the EU Ecolabel criteria and assessment requirements published according to Article 8, the competent body shall assign a registration number to the product.
Operators shall meet the costs of testing and assessment of conformity with EU Ecolabel criteria. Operators may be charged for travel and accommodation costs where an on-site verification is needed outside the Member State in which the competent body is based.
Article 10
Market surveillance and control of the use of the EU Ecolabel
The competent body shall, in respect of products to which it has awarded the EU Ecolabel, verify that the product complies with the EU Ecolabel criteria and assessment requirements published under Article 8, on a regular basis. The competent body shall, as appropriate, also undertake such verifications upon complaint. These verifications may take the form of random spot-checks.
The competent body which has awarded the EU Ecolabel to the product shall inform the user of the EU Ecolabel of any complaints made concerning the product bearing the EU Ecolabel, and may request the user to reply to those complaints. The competent body may withhold the identity of the complainant from the user.
The user of the EU Ecolabel shall, upon request by the competent body which has awarded the EU Ecolabel to the product, grant access to the premises on which the product concerned is produced.
The request may be made at any reasonable time and without notice.
Where, after giving the user of the EU Ecolabel the opportunity to submit observations, any competent body which finds that a product bearing the EU Ecolabel does not comply with the relevant product group criteria or that the EU Ecolabel is not used in accordance with Article 9, it shall either prohibit the use of the EU Ecolabel on that product, or, in the event that the EU Ecolabel has been awarded by another competent body, it shall inform that competent body. The user of the EU Ecolabel shall not be entitled to repayment of the fees referred to in Article 9(4), either in whole or in part.
The competent body shall without delay inform all other competent bodies and the Commission of that prohibition.
The competent body which has awarded the EU Ecolabel to the product shall not disclose, or use for any purpose unconnected with the award for use of the EU Ecolabel, information to which it has gained access in the course of assessing the compliance by a user of the EU Ecolabel with the rules on use of the EU Ecolabel set out in Article 9.
It shall take all reasonable steps to secure the protection of the documents provided to it against falsification and misappropriation.
Article 11
Ecolabelling schemes in the Member States
Article 12
Promotion of the EU Ecolabel
Member States and the Commission shall, in cooperation with the EUEB, agree on a specific action plan to promote the use of the EU Ecolabel by:
awareness-raising actions and information and public education campaigns for consumers, producers, manufacturers, wholesalers, service providers, public purchasers, traders, retailers and the general public,
encouraging the uptake of the scheme, especially for SMEs,
thus supporting the development of the scheme.
Article 13
Exchange of information and experiences
Article 14
Report
By 19 February 2015, the Commission shall submit to the European Parliament and the Council a report on the implementation of the EU Ecolabel scheme. The report shall also identify elements for a possible review of the scheme.
Article 15
Amendment of Annexes
The Commission may amend the Annexes, including modifying the maximum fees provided for in Annex III taking into account the need for fees to cover the costs of running the scheme.
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 16(2).
Article 16
Committee procedure
Article 17
Penalties
Member States shall lay down the rules on penalties applicable to infringements 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 without delay and shall notify it without delay of any subsequent amendment affecting them.
Article 18
Repeal
Regulation (EC) No 1980/2000 is hereby repealed.
Article 19
Transitional provisions
Regulation (EC) No 1980/2000 shall continue to apply to contracts concluded under Article 9 thereof until the date of expiry specified in those contracts, except for its provisions concerning fees.
Article 9(4) of and Annex III to this Regulation shall apply to such contracts.
Article 20
Entry into force
This Regulation shall enter into force on the twentieth 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.
ANNEX I
PROCEDURE FOR THE DEVELOPMENT AND REVISION OF EU ECOLABEL CRITERIA
A. Standard procedure
The following documents must be drawn up:
1. Preliminary report
The preliminary report must contain the following elements:
The preliminary report shall be made available on the Commission's dedicated EU Ecolabel website for comment and reference during the development of the criteria.
Where criteria are to be developed for food and feed product groups, the preliminary report must, with reference to the study undertaken according to Article 6(5), demonstrate the following:
2. Proposal for draft criteria and associated technical report
Following the publication of the preliminary report, a proposal for draft criteria and a technical report in support of the proposal shall be established.
The draft criteria shall comply with the following requirements:
The proposal for draft criteria shall be written in a way that is easily accessible to those wishing to use them. It shall provide justification for each criterion and explain the environmental benefits related to each criterion. It shall highlight the criteria corresponding to the key environmental characteristics.
The technical report shall include at least the following elements:
The proposal for draft criteria and the technical report shall be made available for public consultation on the Commission's dedicated EU Ecolabel website for comment. The party leading the product group development shall distribute the proposal and the report to all interested parties.
At least two open working group meetings shall be held on the draft criteria, to which all interested parties, such as competent bodies, industry (including SMEs), trade unions, retailers, importers, environmental and consumer organisations, shall be invited. The Commission shall also participate in those meetings.
The proposal for draft criteria and the technical report shall be made available at least one month before the first working group meeting. Any subsequent proposal for draft criteria shall be made available at least one month before subsequent meetings. The reasoning behind any changes to the criteria in subsequent drafts shall be fully explained and documented with reference to discussions in the open working groups meetings and comments received in public consultation.
Responses shall be given to all comments received during the criteria development process, indicating whether they are accepted or rejected and why.
3. Final report and draft criteria
The final report shall contain the following elements:
Clear responses to all comments and proposals, indicating whether they are accepted or rejected and why. European Union and non-European Union interested parties shall be treated on an equal footing.
It shall also include the following elements:
Any observations received on the final report shall be taken into consideration, and information on the follow-up to the comments shall be provided on request.
4. Manual for potential users of the EU Ecolabel and competent bodies
A manual shall be established in order to assist potential users of the EU Ecolabel and competent bodies in assessing the compliance of products with the criteria.
5. Manual for authorities awarding public contracts
A manual providing guidance for the use of EU Ecolabel criteria to authorities awarding public contracts shall be established.
The Commission will provide templates translated into all official Community languages for the manual for potential users and competent bodies and for the manual for authorities awarding public contracts.
B. Shortened procedure where criteria have been developed by other EN ISO 14024 type I ecolabelling schemes
A single report shall be submitted to the Commission. This report shall include a section demonstrating that the technical and consultation requirements set out in Part A have been met, along with a proposal for draft criteria, a manual for potential users of the EU Ecolabel and competent bodies, and a manual for authorities awarding public contracts.
If the Commission is satisfied that the report and criteria meet the requirements set out in Part A, the report and the proposal for draft criteria shall be made available for public consultation on the Commission's dedicated EU Ecolabel website for a period of two months for comment.
Responses shall be given to all comments received during the public consultation period, indicating whether each comment is accepted or rejected and why.
Subject to any changes made during the public consultation period, and if no Member State requests an open working group meeting, the Commission may adopt the criteria pursuant to Article 8.
Upon request from any Member State, an open working group meeting shall be held on the draft criteria, in which all interested parties, such as competent bodies, industry (including SMEs), trade unions, retailers, importers, environmental and consumer organisations, shall participate. The Commission shall also participate in that meeting.
Subject to any changes made during the public consultation period or during the working group meeting, the Commission may adopt the criteria pursuant to Article 8.
C. Shortened procedure for non-substantial revision of the criteria
The Commission shall produce a report containing the following:
The report and the proposal for draft criteria shall be made available for public consultation on the Commission's dedicated EU Ecolabel website for a period of two months for comment.
Responses shall be given to all comments received during the public consultation period, indicating whether each comment is accepted or rejected and why.
Subject to any changes made during the public consultation period, and if no Member State requests an open working group meeting, the Commission may adopt the criteria pursuant to Article 8.
Upon request from any Member State, an open working group meeting shall be held on the draft revised criteria, in which all interested parties, such as competent bodies, industry (including SMEs), trade unions, retailers, importers, environmental and consumer organisations, shall participate. The Commission shall also participate in that meeting.
Subject to any changes made during the public consultation period or during the working group meeting, the Commission may adopt the criteria pursuant to Article 8.
ANNEX II
Form of the EU Ecolabel
The EU Ecolabel shall take the following form:
The European Commission will provide further instructions on the design and use of the EU Ecolabel Logo after consulting the EUEB in a separate guidance document.
ANNEX III
1. Application fee
The competent body to which an application is made shall charge a fee for processing the application. This fee shall be no lower than EUR 200 and no higher than EUR 2 000 .
In the case of small and medium enterprises ( 6 ) and operators in developing countries, the maximum application fee shall be no higher than EUR 600.
In the case of micro-enterprises ( 7 ) the maximum application fee shall be EUR 350.
The application fee shall be reduced by 30 % for applicants registered under the EU eco-management and audit scheme (EMAS) or by 15 % certified under the standard ISO 14001. Reductions are not cumulative. Where both systems are met, only the higher reduction shall apply.
The reduction is subject to the condition that the applicant explicitly commits to ensuring full compliance of its ecolabelled products with the relevant EU Ecolabel criteria throughout the period of validity of the contract and that this commitment is appropriately incorporated into its environmental policy and detailed environmental objectives.
Competent bodies may charge a fee for modification or extension of a licence. The fee for this shall not be higher than the application fee and the above reductions shall also apply.
The application fee does not cover the cost of testing and verification by third parties and any on-site inspections that may be required by a third party or competent body. Applicants will meet the cost of such testing, verifications and inspections themselves.
2. Annual fee
The competent body may require each applicant who has been awarded an EU Ecolabel to pay an annual fee. This can be a flat fee or a fee based on the annual value of sales within the Union of the product awarded the EU Ecolabel.
The period covered by the fee will begin from the date of the award of the EU Ecolabel to the applicant.
Where the fee is calculated as a percentage of the annual sales value it shall not be more than 0,15 % of that value. The fee shall be based on ex-factory prices where the product that has been awarded the EU Ecolabel is a good. The fee shall be based on delivery price where it is related to services.
The maximum annual fee shall be EUR 25 000 per product group per applicant.
In the case of SMEs, micro-enterprises or applicants from developing countries, the annual fee shall be reduced by at least 25 %.
The annual fee does not cover the cost of testing, verification and any on-site inspections that may be required. Applicants will cover the cost of such testing, verification and inspections themselves.
3. Inspection fee
The competent body may charge an inspection fee.
ANNEX IV
STANDARD CONTRACT COVERING THE TERMS OF USE OF THE EU ECOLABEL
PREAMBLE
The competent body(full title) hereinafter called ‘the competent body’,
registered at(full address), which for the purposes of the signature of this contract is represented by(name of person responsible),(full name of holder), in his capacity as producer, manufacturer, importer, service provider, wholesaler or retailer whose official registered address is(full address), hereafter called ‘the holder’, represented by(name of person responsible), have agreed the following with regard to the use of the EU Ecolabel, pursuant to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel ( 8 ), hereinafter ‘the EU Ecolabel Regulation’:
1. USE OF THE EU ECOLABEL
1.1. |
The competent body grants the holder the right to use the EU Ecolabel for his products as described in the annexed product specifications, which conform to the relevant product group criteria in force for the periodadopted by the Commission of the European Communities on(date), published in the Official Journal of the European Union of(full reference), and annexed to this contract. |
1.2. |
The EU Ecolabel shall be used only in the forms stipulated in Annex II to the EU Ecolabel Regulation. |
1.3. |
The holder shall ensure that the product to be labelled complies throughout the duration of this contract with all the terms of use and provisions set out in Article 9 of the EU Ecolabel Regulation, at all times. No new application will be required for modifications in the characteristics of the products which do not affect compliance with the criteria. The holder shall however inform the competent body of such modifications by registered letter. The competent body may carry out appropriate verifications. |
1.4. |
The contract may be extended to a wider range of products than those initially foreseen, subject to agreement by the competent body, and subject to the condition that they belong to the same product group and that they also comply with its criteria. The competent body may verify that these conditions are met. The Annex detailing the product specifications shall be modified accordingly. |
1.5. |
The holder shall not advertise or make any statement or use any label or logo in a way which is false or misleading or which results in confusion with, or calls into question the integrity of, the EU Ecolabel. |
1.6. |
The holder shall be responsible under this contract for the manner in which the EU Ecolabel is used in relation to his product, especially in the context of advertising. |
1.7. |
The competent body, including its agents authorised for such purpose, may undertake all necessary investigations to monitor the ongoing compliance by the holder with both the product group criteria and the terms of use and provisions of this contract in accordance with the rules laid down in Article 10 of the EU Ecolabel Regulation. |
2. SUSPENSION AND WITHDRAWAL
2.1. |
In the event that the holder becomes aware that he is failing to meet the terms of use or provisions contained in Article 1 of this contract, the holder shall notify the competent body and refrain from using the EU Ecolabel until those terms for use or provisions have been fulfilled and the competent body has been notified thereof. |
2.2. |
Where the competent body considers that the holder has contravened any of the terms of use or provisions of this contract, the competent body shall be entitled to suspend or withdraw its authorisation to the holder to use the EU Ecolabel, and to take such measures as are necessary to prevent the holder from using it further, including such measures as are provided for in Articles 10 and 17 of the EU Ecolabel Regulation. |
3. LIMITATION OF LIABILITY AND INDEMNITY
3.1. |
The holder shall not include the EU Ecolabel as part of any guarantee or warranty in relation to the product referred to in Article 1.1 of this contract. |
3.2. |
The competent body, including its authorised agents, shall not be liable for any loss or damage sustained by the holder arising out of the award and/or use of the EU Ecolabel. |
3.3. |
The competent body, including its authorised agents, shall not be liable for any loss or damage sustained by a third party and arising out of the award and/or use, including advertising, of the EU Ecolabel. |
3.4. |
The holder shall indemnify and keep indemnified the competent body and its authorised agents against any loss, damage or liability sustained by the competent body, or its authorised agents, as a result of a breach of this contract by the holder or as a result of reliance by the competent body on information or documentation provided by the holder, including any claims by a third party. |
4. FEES
4.1. |
The amount of application fee and annual fee shall be defined in accordance with Annex III of the EU Ecolabel Regulation. |
4.2. |
Use of the EU Ecolabel is conditional upon all relevant fees having been paid in due time. |
5. CONTRACT DURATION AND APPLICABLE LAW
5.1. |
Except as provided for in Article 5.2, 5.3 and 5.4, this contract shall run from the date on which it is signed until (…) or until expiry of the product group criteria, whichever is sooner. |
5.2. |
Where the holder has contravened any of the terms of use or provisions of this contract within the meaning of Article 2.2, the competent body shall be entitled to treat this as a breach of contract entitling the competent body, in addition to the provisions in Article 2.2, to terminate the contract, by registered letter to the holder, at an earlier date than that set out in Article 5.1, within (a time period to be determined by the competent body). |
5.3. |
The holder may terminate the contract by giving the competent body three months' notice by registered letter. |
5.4. |
If the product group criteria as stated in Article 1.1 are extended without amendments for any period, and if no written notice of termination from the competent body has been given at least three months before the expiry of the product group criteria and of this contract, the competent body shall inform the holder at least three months in advance that the contract shall be automatically renewed for as long as the product group criteria remain in force. |
5.5. |
After the termination of this contract the holder may not use the EU Ecolabel in relation to the product specified in Article 1.1 and in the Annex to this contract, either as labelling or for advertising purposes. The EU Ecolabel may nevertheless, for a period of six months after the termination, be displayed on stock held by the holder or others and manufactured before the termination. This latter provision shall not apply if the contract has been terminated for the reasons set out in Article 5.2. |
5.6. |
Any dispute between the competent body and the holder or any claim by one party against the other based on this contract which has not been settled by amicable agreement between the contracting parties, shall be subject to the applicable law determined in accordance with Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) ( 9 ) and Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II ( 10 )). The following Annexes shall form part of this contract:
—
a copy of Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel, in (the relevant Community language(s)),
—
product specifications, which shall at least include details of the names, and/or the manufacturer's internal reference numbers, the manufacturing sites, and the related EU Ecolabel registration number or numbers,
—
a copy of Commission Decision (… on product group criteria),
|
Done at date
…
(Competent body)
Designated person
…
(Legally binding signature)
…
(Holder)
Designated person
…
(Legally binding signature)
ANNEX V
REQUIREMENTS RELATING TO COMPETENT BODIES
1. |
A competent body shall be independent of the organisation or the product it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be designated as a competent body. |
2. |
A competent body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the competent body or the use of such products for personal purposes. A competent body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgment or integrity in relation to conformity assessment activities for which they are designated. This shall in particular apply to consultancy services. Competent bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities. |
3. |
Competent bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities. |
4. |
A competent body shall be capable of carrying out all the conformity assessment tasks assigned to it by this Regulation, whether those tasks are carried out by the competent body itself or on its behalf and under its responsibility. At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been designated, a competent body shall have at its disposal the necessary:
(a)
technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
(b)
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a competent body and other activities;
(c)
procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process. It shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. |
5. |
The personnel responsible for carrying out conformity assessment activities shall have the following:
(a)
sound knowledge covering all the conformity assessment activities in relation to which the competent body has been designated;
(b)
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out. |
6. |
The impartiality of the competent bodies, of their top level management and of the assessment personnel shall be guaranteed. The remuneration of the top-level management and assessment personnel of a competent body shall not depend on the number of assessments carried out or on the results of those assessments. |
7. |
Competent bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the working group of competent bodies referred to in Article 13 of this Regulation and apply as general guidance the administrative decisions and documents produced as a result of the work of that group. |
( 1 ) OJ L 311, 28.11.2001, p. 67.
( 2 ) OJ L 311, 28.11.2001, p. 1.
( 3 ) OJ L 31, 1.2.2002, p. 1.
( 4 ) OJ L 353, 31.12.2008, p. 1.
( 5 ) OJ L 396, 30.12.2006, p. 1.
( 6 ) Small and medium enterprises as defined by Commission Recommendation 2003/361/EC (OJ L 124, 20.5.2003, p. 36).
( 7 ) Micro-enterprises as defined by Recommendation 2003/361/EC.
( 8 ) OJ L 27, 30.1.2010, p. 1.
( 9 ) OJ L 177, 4.7.2008, p. 6.
( 10 ) OJ L 199, 31.7.2007, p. 40.