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Document 31998L0008
Biocides (until 1 September 2013)
This summary has been archived and will not be updated. See 'Safe insect repellents, disinfectants and other industrial chemicals (biocides) in the EU' for an updated information about the subject.
Biocides (until 1 September 2013)
The European Union is establishing a regulatory framework for the placing of biocidal products on the market, with a view to ensuring a high level of protection for man and the environment and the proper functioning of the common market.
ACT
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market [See amending act(s)].
SUMMARY
Scope
The Directive concerns:
The Directive applies to biocidal products, i.e. non-agricultural pesticides as defined in Article 2 of the Directive. An exhaustive list of the products covered by this Directive is annexed below.
The Directive does not apply to products falling within the scope of the following legislative acts:
Obligations of the Member States
Member States must ensure the authorisation, classification, labelling, packaging and proper use of the biocidal products in line with this Directive. Proper use includes measures necessary to keep the use of biocidal products to a minimum as well as an obligation to ensure that their use in the workplace is in compliance with the directives on health and safety protection for workers. Member States must appoint one or more competent authorities responsible for complying with the obligations imposed on them under this Directive, including granting authorisations and receiving information relating to biocidal products so as to be able to meet any medical demand.
Each quarter Member States must inform the other Member States and the Commission of any biocidal products which have been registered and authorised within their territory or for which an authorisation or registration has been refused, modified, renewed or cancelled.
Every three years since 2003, Member States have submitted reports to the Commission in which they provide information on any poisonings involving biocidal products.
Principle of mutual recognition of authorisations
The authorisation system is based on the principle of mutual recognition of authorisations. Under this principle, a biocidal product that has already been authorised or registered in one Member State must be authorised in another Member State within 120 days or registered within 60 days of an application being received by the other Member State.
However, there are a number of derogations from mutual recognition:
Conditions governing the granting of authorisations
It is compulsory to issue product marketing authorisation, subject to certain derogations in the case of low-risk products. The Member States may authorise a biocidal product only if:
A biocidal product classified as toxic, carcinogenic and mutagenic or toxic for reproduction is not authorised for marketing to the general public.
Authorisations may be reviewed at any time during the period for which they have been granted.
Placing on the market of active substances
An active substance for use in biocidal products may be placed on the market if:
All active substances approved for inclusion in biocidal products are listed in Annex I or IA to the Directive. The maximum period during which a substance may be listed in the Annex is ten years.
Inclusion of a new active substance in the Annex
With a view to listing a new active substance in Annex I, IA or IB to the Directive, the Commission presents a proposal to the Standing Committee. The proposal is based on an evaluation of the substance carried out with the help of data supplied by the applicant.
Cancellation of an authorisation
An authorisation is cancelled if:
Modification of an authorisation
An authorisation may be modified:
It is the responsibility of the holder of an authorisation for a biocidal product to pass on immediately to the competent authority any information of which he is aware concerning an active substance or a biocidal product containing it and which may affect continuing authorisation.
Procedure for requesting authorisation
An application for authorisation should come from the person initially responsible for placing a biocidal product on the market in a Member State and should be addressed to the competent authority in that Member State. In order to obtain the authorisation, the applicant must provide the following:
The authorisation to place biocidal products on the market and entries of substances in Annex I, IA or IB are subject to the payment of a charge.
Member States may only use the information contained in the dossier accompanying the application for authorisation for the benefit of another applicant on certain conditions, one of which stipulates that the written agreement of the first applicant must be obtained.
Provisions applicable to a biocidal product that has already been authorised
Applicants for authorisation to place products on the market may use information provided by a previous applicant, in so far as the subsequent applicant can provide evidence that the product is similar and its active substances are the same as in the product previously authorised.
Before carrying out experiments involving vertebrate animals, an applicant for authorisation of a biocidal product must enquire of the competent authority of the Member State to which they intend to submit their application:
The applicant and holder or holders of former authorisations are encouraged to come to an agreement on the shared use of information to avoid duplicating the testing on vertebrate animals.
Exemptions
The Directive provides for the possibility of exemption from the requirements for placing biocidal products on the market. A Member State may temporarily authorise placing biocidal products on the market which do not comply with the provisions of the Directive for limited and controlled use if such measures appear necessary due to unforeseen danger not able to be contained by other means.
Role of the Commission
Following the adoption of the Directive, the Commission is to embark on a programme of work, systematically examining the risks associated with all active substances authorised for inclusion in biocidal products. The programme has been set up under a Regulation adopted by the Standing Committee on Biocidal Products, and will run for ten years. Its task is to examine all active substances already available on the market as of 14 May 2000 in the form of active substances for a biocidal product, with the exception of products used for purposes of research, science and product development.
Not more than two years prior to the completion of the programme of work, the Commission will send a progress report on the implementation of the programme to the European Parliament and the Council.
To further improve implementation of the Directive, the Commission must prepare technical guidelines which are to be published in the Official Journal of the European Communities.
Research and development
Experiments or tests carried out for the purposes of research or development involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product are subject to several conditions, including an obligation to obtain authorisation from the competent authority if the tests are likely to have harmful effects on human or animal health or on the environment.
Classification, packaging and labelling
Biocidal products are classified, packaged and labelled in accordance with Directive 1999/45/EC on the classification, packaging and labelling of dangerous preparations which is applicable until 1 June 2015. However, in order to avoid any misunderstandings (confusion with foodstuffs or drinks, for example), the Directive lays down additional requirements with regard to the packaging and labelling of such products.
Safety measures
A system of specific information is introduced in order to enable professional and industrial users of biocidal products to take the necessary measures for the protection of the environment and health. This system must take the form of a data safety sheet provided by those responsible for placing the product on the market.
Confidentiality
The Directive allows the applicant to ask for certain sensitive information to be kept confidential from all persons other than the competent authorities and the Commission. Some information, however, (such as the name and address of the applicant, the physical and chemical properties of the biocidal product, etc.), cannot be included in this confidentiality clause.
Safeguard clause
The Directive allows the applicant to ask for certain sensitive information to be kept confidential from all persons other than the competent authorities and the Commission. Some information, however, (such as the name and address of the applicant, the physical and chemical properties of the biocidal product, etc.), cannot be included in this confidentiality clause.
Advertising
Marketing biocidal products is subject to certain conditions and must be in particular accompanied by wording which makes clear that the product should be used with care.
Comitology
The Commission is assisted by a Standing Committee on Biocidal Products. The Committee operates according to a regulatory procedure in the case of certain tasks, such as taking decisions to grant or withhold a prohibition (safeguard clause) or according to a management procedure in other cases, such as the listing of an active substance in the Annex and granting confidentiality.
References
Act |
Entry into force - Date of expiry |
Deadline for transposition in the Member States |
Official Journal |
Directive 98/8/EC |
14.5.1998 |
13.5.2000 |
OJ L 123 of 24.4.1998 |
Amending act(s) |
Entry into force |
Deadline for transposition in the Member States |
Official Journal |
Regulation (EC) No 1882/2003 |
20.11.2003 |
- |
OJ L 284 of 31.10.2003 |
Directive 2007/47/EC |
11.10.2007 |
21.12.2008 |
OJ L 247 of 21.9.2007 |
Directive 2008/31/EC |
21.3.2008 |
- |
OJ L 81 of 20.3.2008 |
Directive 2009/107/EC |
26.10.2009 |
14.5.2010 |
JO L 262 du 6.10.2009 |
The successive amendments and corrections to Directive 98/8/EC have been incorporated into the basic text. This consolidated version is for reference purpose only.
LAST AMENDMENTS TO THE ANNEXES
Annex I – List of active substances with requirements agreed at community level for inclusion in biocidal products Directive 2011/10/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/11/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/12/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/13/EU [Official Journal L 34 of 9.2.2011].
RELATED ACTS
Evaluation of active substances
Directive 98/8/EC provides for an evaluation of all active substances already on the market as at 14 May 2000 in the form of active substances in biocidal products. The ten-year programme is divided into two phases: the first, which began in 2000, is concerned with the identification of the substances, and the second, which began in 2003, with their evaluation.
Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products [Official Journal L 228 of 8.9.2000].
The first phase of this Regulation adopted on 7 September 2000 aims to:
Producers should identify the active substances to the Commission not later than 18 months after the entry into force of this Regulation using the special software provided free of charge by the Commission. Should the producer or formulator wish to request the listing of an active substance in Annex I or IA to the Directive, notification rather than identification will be necessary. The producer or formulator is required to provide the Commission with the information specified in Annex II to the Regulation, using the special Commission software, within 18-months of the Regulation's date of entry into force. The Commission, in cooperation with the Member States, will then decide whether to accept or reject the notification. If it is accepted, the notifier must provide all the data and information necessary evaluating the active substance with a view to its possible inclusion in the Annex to the Directive during the second phase of the review programme.
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market [Official Journal L 325 of 11.12.2007]. This Regulation replaces and repeals Regulation (EC) No 2032/2003 of 4 November 2003, which had been subject to successive amendments. These various amendments made it difficult to read, particularly the Annexes concerning lists of identified active substances (Annexes I and VII to Regulation EC No 2032/2003), notified substances (Annexes II, V and VIII), and identified but not notified active substances (Annex III).
Regulation (EC) No 1451/2007 thus rationalises these lists and consolidates their successive amendments:
Application of the legislation
Report from the Commission to the Council and the European Parliament of 8 October 2008 – Evaluation of the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market (submitted in accordance with Article 18 (5) of the Directive) and progress Report on the work programme referred to in Article 16(2) of the same Directive [COM(2008) 620 – Not published in the Official Journal]. The Directive set the foundations for improving the level of environmental and public health protection which is offered to European Union citizens in relation to biocidal products. During the five years prior to the effective start of the active substance review in 2004, the Commission, in cooperation with the Member States and industry, inventoried biocidal products on the market and put into place a structured procedure for the assessment and evaluation of the existing active substances.
The review programme will not be finalised by the date originally set, 14 May 2010, which also happens to be the date by which national rules for the placing on the market of biocidal products will cease to apply. Allowing the transitional period to elapse without completing the review programme for biocidal products,would mean that the harmonised rules of the Directive about product authorisation could not apply for all the biocidal products already on the market. If neither set of rules – harmonised or national – could apply, there would be a legal void with regard to the placing on the market of biocidal products. This could have negative effects on public health (if important biocidal products were withdrawn from the market) and would have severe adverse economic effects on all companies operating in the biocides sector.
Therefore, this Communication is accompanied by a proposal for the revision of the Directive which would extend the review programme, the transitional period, and certain provisions on data protection that accompany this period for an additional three years.
Last updated: 23.02.2011