Biocides [EU]

Biocidal products

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.

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

Scope

The Directive concerns:

the authorisation and placing on the market of biocidal products in the Member States;
the mutual recognition of authorisations within the Community;
the establishment at Community level of a list of active substances which may be used in biocidal products.

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:

Directive 2001/83/EC (medicinal products for human use);
Directive 2001/82/EC (veterinary medicinal products);
Regulation (EC) No 726/2004 (European Medicines Agency);
Directive 90/385/EEC (active implantable medical devices)
Directive 93/42/EEC (medical devices);
Directive 98/79/EC (in vitro diagnostic medical devices);
Regulation (EC) No 1333/2008 (food additives)
Directive 88/388/EEC (flavourings in foodstuffs);
Regulation (EC) No 1935/2004 (materials and articles intended to come into contact with foodstuffs);
Directive 90/167/EEC (medicated feedingstuffs);
Regulation (EC) No 767/2009 (feed);
Regulation (EC) No 1831/2003 (use of additives in animal nutrition);
Regulation (EC) No 1223/2009 (cosmetic products);
Regulation (EC) No 1107/2009 (plant protection products).

This Directive is applicable, without prejudice to the Community provisions adopted by virtue of:

Regulation (EC) No 1907/2006 (chemical products);
Regulation (EC) No 1107/2009 (plant protection products);
Directive 98/24/EC (protection of workers from the risks related to exposure to chemical, physical and biological agents);
Directive 2006/114/EC (misleading advertising);
Directive 89/391/EEC (health and safety at work).

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:

The Member State may request that certain conditions relating to the classification, labelling and packaging of biocidal products be adapted under certain circumstances. These involve the quantity of the target species in the territory of the Member State, the degree of resistance of the target organism to the biocidal product and the circumstances under which it is used;
Where a Member State believes that a low-risk biocidal product which has been registered in another Member State does not comply with the definition set out in the Directive it may provisionally refuse to register it. In such cases it must notify the competent authority responsible for verifying the dossier;
Where a Member State believes a biocidal product authorised by another Member State does not meet the conditions for granting the authorisation and proposes to refuse the authorisation or registration it must notify the Commission, the other Member States and the applicant. The case will then be referred to the Standing Committee on Biocidal Products for a final decision which must be unanimously accepted;
Unless otherwise stated in the Treaty, Member States may refuse to grant mutual recognition of authorisations issued for types of products used against vermin, fish and birds, provided that such action is justifiable and does not frustrate the objectives of the Directive.

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:

its active substances are listed in the Annexes to the Directive and the requirements set out in the Annexes are met;
it is established that:
- the biocidal product is sufficiently effective,
- it has no unacceptable effects on the target organisms,
- it has no unacceptable effects on human health or animal health or on surface water or groundwater,
- it has no unacceptable effect on the environment;
the nature and quantity of its active substances can be determined according to the requirements listed in the Annexes to the Directive;
its physical and chemical properties have been deemed acceptable for purposes of appropriate use, storage and transport of the product.

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:

a dossier has been submitted to a Member State accompanied by a declaration that the active substance is intended for inclusion in a biocidal product. This condition applies to active substances which did not have an authorisation to be placed on the market before 14 May 2000;
the active substance is classified, packaged and labelled in accordance with Directive 67/548/EEC which is applicable until 1 June 2015.

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:

the active substance is no longer included in Annex I or IA to the Directive;
the conditions for obtaining the authorisation are no longer satisfied;
false particulars were supplied with the application for authorisation;
at the request of the authorisation holder.

Modification of an authorisation

An authorisation may be modified:

where a Member State considers that this is necessary to protect health and the environment;
at the request of the holder.

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:

a dossier or letter of access concerning the biocidal product and containing the information specified in Annex IIB, IIIB or IVB depending on the type of biocidal product. The required information will contain, for example: the applicant’s name and address, the name and composition of the product, proposed uses, protective measures to be taken, among others. Dossiers for low-risk biocidal products are less detailed;
a dossier or letter of access for each active substance contained in the biocidal product and containing the information specified in Annexes IIA, IIIA and IVA.

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:

whether the biocidal product in question is similar to a biocidal product already authorised;
as to the name and address of the holder of the authorisation.

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

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.

AMENDMENT OF THE ANNEXES

Annex I – List of active substances permitted for inclusion in biocidal products
Directive 2006/140/EC (sulfuryl fluoride) [Official Journal L 414 of 30.12.2006];
Directive 2007/20/EC (dichlofluanid) [Official Journal L 94 of 4.4.2007];
Directive 2007/69/EC (difethialone) [Official Journal L 312 of 30.11.2007];
Directive 2008/15/EC (clothianidin) [Official Journal L 42 of 16.2.2008];
Directive 2008/16/EC (etofenprox) [Official Journal L 42 of 16.2.2008];
Directive 2008/75/EC (carbon dioxide) [Official Journal L 197 of 25.7.2008];
Directive 2008/77/EC (thiamethoxam) [Official Journal L 198 of 26.7.2008];
Directive 2008/78/EC (propiconazole) [Official Journal L 198 of 26.7.2008];
Directive 2008/79/EC (IPBC) [Official Journal L 200 of 29.7.2008];
Directive 2008/80/EC (cyclohexylhydroxydiazene 1-oxide, potassium salt (K-HDO)) [Official Journal L 200 of 29.7.2008];
Directive 2008/81/EC (difenacoum) [Official Journal L 201 of 30.7.2008];
Directive 2008/85/EC (thiabendazole) [Official Journal L 239 of 6.9.2008];
Directive 2008/86/EC (tebuconazole) [Official Journal L 239 of 6.9.2008];
Directive 2009/84/EC (sulfuryl fluoride) [Official Journal L 197 of 29.7.2009];
Directive 2009/85/EC (coumatetralyl) [Official Journal L 198 of 30.7.2009];
Directive 2009/86/EC (fenpropimorph) [Official Journal L 198 of 30.7.2009];
Directive 2009/87/EC (indoxacarb) [Official Journal L 198 of 30.7.2009];
Directive 2009/88/EC (thiacloprid) [Official Journal L 199 of 31.7.2009];
Directive 2009/89/EC (nitrogen) [Official Journal L 199 of 31.7.2009];
Directive 2009/91/EC (disodium tetraborate) [Official Journal L 201 of 1.8.2009];
Directive 2009/92/EC (bromadiolone) [Official Journal L 201 of 1.8.2009];
Directive 2009/93/EC(alphachloralose) [Official Journal L 201 of 1.8.2009];
Directive 2009/94/EC (boric acid) [Official Journal L 201 of 1.8.2009];
Directive 2009/95/EC (aluminium phosphide) [Official Journal L 201 of 1.8.2009];
Directive 2009/96/EC (disodium octaborate tetrahydrate) [Official Journal L 201 of 1.8.2009];
Directive 2009/98/EC (boric acid) [Official Journal L 203 of 5.8.2009];
Directive 2009/99/EC (chlorophacinone) [Official Journal L 203 of 5.8.2009];
Directive 2009/150/EC (flocoumafen) [Official Journal L 313 of 28.11.2009];
Directive 2009/151/EC (tolylfluanid) [Official Journal L 313 of 28.11.2009].

Annex IVA – Data set for active substances
Directive 2006/50/EC [Official Journal L 142 of 30.5.2006].

Annex IVB – Data set for biocidal products
Directive 2006/50/EC [Official Journal L 142 of 30.5.2006].

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:

identify the relevant substances and specify which need to be evaluated with a view to their possible listing in Annex I, IA or IB to Directive 98/8/EC (active substances authorised for use in biocidal products);
identify the first priority list of active substances to be evaluated during the second phase of the programme (the existing active substances used in biocidal products of type 8 (wood preservatives) and type 14 (rodenticides)).

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 1687/2002 of 25 September 2002 on an additional period for notification of certain active substances already on the market for biocidal use as established in Article 4(1) of Regulation (EC) No 1896/2000 [Official Journal L 258 of 26.09.2002].
This Regulation extends until 31 January 2003 the period for notifying the Commission of existing active substances that have only been identified, or only notified for certain product types. It also includes a list of new definitions for the purpose of the Regulation.

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].
Amended by:
Commission Decision 2009/395/EC of 14 May 2009 [Official Journal L 124 of 20.5.2009].
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:

by creating an Annexe I, corresponding to the list of existing active substances, i.e. substances that are known to have been placed on the market as active biocidal substances before 14 May 2000 (consolidation of Annexes I and VII to the previous Regulation);
by creating an Annexe II, corresponding to the list of active substances currently notified to the review programme, updated, indicating the name of the reporting Member State (consolidation of Annexes II, V and VIII to the previous Regulation);
by deleting the former Annex III to the previous Regulation EC No 2032/2003, since it was no longer of use.

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.