The Commission presents a proposal for a Council Directive amending Directive 98/8/EC of the European Parliament and of the Council so as to include creosote as an active substance in Annex I. In accordance with the requirements of Directive 98/8/EC on biocidal products, a work programme was carried out concerning the review of all active substances contained in biocidal products already on the market on 14 May 2000 (existing active substances). Creosote was identified as an existing active substance and evaluated in the context of that work programme.

In the Commission’s view, the conclusions of the evaluation of creosote are that the conditions for the inclusion of the substance in Annex I are met under certain conditions . Accordingly, the Commission submitted a draft Directive for vote in the Committee established under Directive 98/8/EC. The Committee did not deliver a favourable opinion on the draft Directive in its meeting on 17 December 2010. Thus in accordance with the procedure set out in Article 5(a) of Decision 1999/468/EC this proposal for a Council Directive is submitted to Council and forwarded to the European Parliament.

It appears from the assessment report that wood preservatives containing creosote may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, when applied on wood in some of the scenarios evaluated. Furthermore, there were strong indications in the stakeholder consultation in 2008 that there are considerable socio-economic benefits of using creosote in certain applications. Life cycle analyses published in the context of the consultation have suggested that, in certain cases, no appropriate alternatives to creosote less damaging to the environment exist. However, for certain wood use scenarios presented in the assessment report, unacceptable risks for the environment were identified in the risk assessment .

Furthermore:

creosote is considered to be a non-threshold carcinogen and is classified as carcinogen category 1B in accordance with Regulation (EC) No 1272/2008; creosote, which is a mixture of hundreds of compounds, contains mainly polycyclic aromatic hydrocarbons ('PAHs'). Some of these have been considered by the Committee for Risk Assessment of the European Chemicals Agency as persistent, bioaccumulative and toxic ('PBT'; anthracene ) or very persistent and very bioaccumulative ('vPvB'; fluoranthene, phenanthrene and pyrene ) in accordance with the criteria set out in Regulation (EC) No 1907/2006 (REACH); PAHs are listed as substances subject to release reduction provisions in the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants ('POPs') and in Annex III to Regulation (EC) No 850/2004; Directive 2000/60/EC on water policy identifies PAHs as priority hazardous substances, from which pollution of surface waters through discharge, emission or loss must cease or be phased out.

The Commission considers that the conclusions of the evaluation of creosote are that the conditions for the inclusion of the substance in Annex I are met under certain conditions. These are as follows:

biocidal products containing creosote may only be authorised for uses where the authorising Member State, based on an analysis regarding the technical and economic feasibility of substitution which it shall request from the applicant, as well as on any other information available to it, concludes that no appropriate alternatives are available. Those Member States authorising such products in their territory shall no later than 31 July 2016 submit a report to the Commission justifying their conclusion that there are no appropriate alternatives and indicating how the development of alternatives is promoted. The Commission will make these reports publicly available; the active substance is to be subject to a comparative risk assessment in accordance with Article 10(5)(i) before its inclusion in Annex I is renewed; when assessing the application for authorisation of a product, Member States shall assess those uses and those risks to environmental compartments and populations that have not been representatively addressed at the Union level risk assessment;

Member States shall ensure that authorisations are subject to the following conditions:

creosote may only be used under the conditions mentioned in entry No 31 in Annex XVII to Regulation (EC) No 1907/2006 (REACH); creosote shall not be used for the treatment of wood intended for those uses referred to in point 3 of the second column of entry No 31 in Annex XVII to REACH; appropriate risk mitigation measures shall be taken to protect workers, including downstream users, from exposure during treatment and handling of treated wood in compliance with REACH and Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens mutagens at work (Sixth individual Directive); appropriate risk mitigation measures must be taken to protect soil and aquatic compartments. In particular, labels and safety data sheets of products authorised shall indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water and that any losses must be collected for re-use or disposal.

The aim of this report is to discuss the implementation of Directive 98/8/EC and the review programme referred to in Article 16(2), over the period from 14 May 2000 to 1 March 2008. It is noted, however, that the implementation of a significant part of the Directive's provisions has not started. Notably, there have been no authorisations of biocidal products yet. The report includes the situation in the 10 Member States who joined the EU on 1 January 2004, but does not cover the situation in Bulgaria or Romania.

Progress made under the review programme to date : at the end of the first phase of the review programme, the industry had identified 964 substances as active ingredients of biocidal products that were present on the market before 14 May 2000. Of these, 416 active substances were notified for evaluation in one or more product-types. 548 (about 60%) of the identified substances were not supported and were subsequently phased-out by 1 September 2006. It is estimated that these active substances were used in only 13%-33% of the biocidal products on the market. By 1 March 2008, half of the initially notified active substance/product-type combinations have been withdrawn from the review programme

Ongoing work under the review programme : the original timetable of the review programme (14/05/2010) was based on the assumption that two years would suffice from submission of the dossier by the participant to adoption of a decision on the inclusion of an active substance. In practice this proved impossible to achieve. No active substance has been evaluated to-date in less than three years and the average period of evaluation seems to be closer to approximately four to five years so far. The Commission discusses the factors responsible for the slower than scheduled pace of the review programme. It is estimated that the last decisions on the remaining active substances will be taken only in 2014.

The report goes on to discuss issues such as low-risk products, basic substances, frame formulations and data protection.

Conclusion: the Directive has set the foundations for improving environmental and public health in relation to biocidal products. During a five year effort before the effective start of the active substance review in 2004, the Commission has inventoried the European biocides market and put into place a structured procedure for the assessment and evaluation of the existing active substances. Although it has not been possible to meet the time lines originally envisaged, progress has been similar to if not faster than other comparable regulatory systems, such as for plant protection products (Directive 91/414/EEC) or existing chemical substances (Regulation (EC) n° 793/93).

The review programme will not be finalised by 14/05/2010, which is also the date by which the 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 active substances 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 and would have severe adverse economic effects on all companies operating in the biocides sector. Therefore, this paper is accompanied by a proposal for the revision of the Directive that would extend the review programme, the transitional period, and certain provisions on data protection that accompany this period for an additional three years ( COD/2008/0188 ).

The substantive revision of the Directive : the Commission is also considering:

the simplification and adaptation of the scope of the Directive; a tiered approach to data requirements that will take proportionality into consideration; a simplification of the data protection rules, including some mandatory data-sharing; greater harmonisation or co-ordination of fee structures; improvement of the simplified procedures; measures to facilitate complying with the Directive for SMEs, and measures to encourage innovation; measures to imptove the internal market in biocidal products.

LEGISLATIVE ACT : Commission Regulation 1048/2005/EC amending Regulation 2032/2003 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.

CONTENT : Article 4 of Commission Regulation 2032/2003/EC lays down that, from the date of entry into force, any existing active substance not listed in Annex I to that Regulation is to be considered as not having been placed on the market for biocidal purposes before 14 May 2000. As a consequence biocidal products containing active substances not listed in Annex I may no longer be placed on the market, unless inclusion into Annex I or IA to Directive 98/8/EC is applied for in accordance with Article 11 of that Directive, and provisional authorisation has been received in accordance with Article 15(2) of that Directive. However, a limited number of active substances have been detected by the Member States which were not identified or notified before the time limit laid down in Commission Regulations 1896/2000/EC and 1687/2002/EC although there is evidence they were contained in biocidal products placed on the market before 14 May 2000. Some of these active substances are important from a socioeconomic perspective or for protection of public health. It is therefore appropriate to draw up a further list of active substances that should be allowed to remain on the market until 1 September 2006.

Certain substances not included in Annex II to Regulation 2032/2003/EC are applied in uses for which Member States claim that there is evidence demonstrating the essential need for reasons of health, safety, and protection of cultural heritage, or the use is critical for the functioning of society in the absence of technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment or health. It is therefore appropriate to introduce a system for applying for an extension of the period for marketing of biocidal products containing those substances. Such extensions should only be granted for the requesting Member States if the requests are justified, continued use does not give rise to concerns for human health and the environment, and, where appropriate, alternatives are being developed. The extension should only be allowed until 14 May 2010 at the latest.

In accordance with Article 4(2) of Regulation 2032/2003, placing on the market of biocidal products containing active substances not notified, or not notified for the appropriate product types, has to stop on 1 September 2006 at the latest. For certain substances or substance/product type combinations that have so far not been notified, there is now an interest by economic operators to prepare complete dossiers in view of their inclusion into Annex I or IA to Directive 98/8/EC. It is therefore appropriate, to introduce the possibility to prolong the marketing deadline for biocidal products containing such substances, in the product type concerned, provided interested operators submit complete dossiers well before 1 September 2006. If these dossiers are accepted, an extension of the period for placing those products on the market in the product types concerned should be allowed until the end of the evaluation of the complete dossiers, which should take place in parallel with the evaluation of the notified substances for the product types concerned.

For a number of notified existing active substances/product type combinations — in particular those notified for product types 8 and 14 — all participants have withdrawn or not complied with their obligations, and no other economic operator or Member State has expressed an interest to take over the role of participants within the given deadlines. Furthermore, following the recent classification by the competent authorities and the Commission of certain milk hygiene products as biocidal products in product type 3 as defined in Annex V to Directive 98/8/EC, it is appropriate to include into Annex II certain substances used in those milk hygiene products where producers, formulators or associations believing that these were not concerned by Directive 98/8/EC did not submit notifications before the deadlines established by Regulations 1896/2000/EC and 1687/2002/EC, but have done so before the adoption of this Regulation. Annexes II and III to Regulation 2032/2003/EC should therefore be amended accordingly. Annex V, Parts A, B, C, and D, and Annex VI should also be amended in the light of the provisions contained in this Regulation.

For one substance listed in Annexes I and II to Regulation 2032/2003/EC an incorrect CAS number and for another one an erroneous common name are indicated. Four substances are not listed in Annexes I and III, although they were identified within the deadlines set by Regulation 1896/2000/EC. This should be rectified.

Regulation 2032/2003/EC should therefore be amended accordingly.

This is the aim of the present Regulation.

ENTRY INTO FORCE : 29/07/2005.

LEGISLATIVE ACT : Commission Regulation 2032/2003/EC 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, and amending Regulation 1896/2000/EC.

CONTENT : under Regulation 1896/2000/EC existing active substances for use in biocidal products had to be identified and those to be evaluated with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC in one or more product types had to be notified no later than 28 March 2002. An additional period for the submission of notifications for existing active substances that had been identified only or had been notified only in respect of certain product types was granted by Commission Regulation 1687/2002/EC 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 1896/2000/EC. That period expired on 31 January 2003.

It is necessary to establish an exhaustive list of existing active substances that have been identified in accordance with Article 3(1) or Article 5(2) of Regulation 1896/2000/EC or in respect of which equivalent information has been submitted in a notification in accordance with Article 4(1) of that Regulation.

It is also necessary to establish an exhaustive list of existing active substances in respect of which at least one notification has been accepted in accordance with Article 4(2) of Regulation 1896/2000/EC or in which a Member State has expressed an interest in accordance with Article 5(3) of that Regulation. That list should specify the product types concerned.

More specifically, as regards the second phase of the review programme, priorities for the evaluation of existing active substances should be established. The lists of prioritised substances and the dates for submission of complete dossiers should be specified. The task of evaluation should be distributed among the competent authorities of the various Member States. In order to enable new Member States to participate in the review programme after their accession, it is appropriate, for the time being, to designate Rapporteur Member States only in respect of certain product types. A Member State which has indicated an interest in seeking review of a particular active substance should not be designated Rapporteur Member State for that substance.

In order to avoid duplication of work, and in particular to reduce testing involving vertebrate animals, the requirements concerning preparation and submission of the complete dossier should be such as to encourage those whose notifications have been accepted, hereinafter "participants", to act collectively, in particular by submitting collective dossiers. It should be possible for the Rapporteur Member State to make available the reference to any test involving vertebrate animals that has been carried out in respect of a notified existing active substance unless that reference is confidential under Article 19 of Directive 98/8/EC. Also, in order to gain experience on the appropriateness of data requirements and to ensure that the review of active substances is carried out in a cost-effective way, participants should be encouraged to provide information on the costs of compiling a dossier and on the need to carry out tests on vertebrate animals.

The present Regulation lays down detailed rules for the implementation of the second phase of the programme of work for the systematic examination of all active substances already on the market on 14 May 2000 as active substances of biocidal products referred to in Article 16(2) of Directive 98/8/EC.

ENTRY INTO FORCE : 14/12/2003.

LEGISLATIVE ACT : Commission Regulation 1896/2000/EC 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.

CONTENT : pursuant to Directive 98/8/EC, a programme of work is to be initiated for the review of all active substances of biocidal products already on the market on 14 May 2000.

The first phase of the review programme is intended to enable the Commission to identify existing active substances of biocidal products and specify those which should be evaluated for a possible inclusion in Annex I, Annex IA or Annex IB to the Directive. Given the expected high number of existing active substances which are candidates for such inclusion, information is needed to set priorities for a further phase of the review programme, which is planned to be initiated in 2002.

It is necessary to specify the relationship between producers, formulators, Member States and the Commission and the obligation on each of the parties for the implementation of the review programme.

In order to establish an exhaustive list of existing active substances, an identification procedure should be laid down by which all producers are to submit information on existing active substances of biocidal products to the Commission. Formulators should also have the opportunity of identifying existing active substances.

The present Regulation lays down provisions for the establishment and implementation of the first phase of the programme of work for the systematic examination of all active substances already on the market on 14 May 2000 as active substances of biocidal products.

ENTRY INTO FORCE : 28/09/2000.

OBJECTIVE: to harmonize regulations concerning the placing on the market of biocidal products and their active substances with a view to facilitating the proper operation of the internal market and ensuring a high level of protection of health and the environment.

COMMUNITY MEASURE: European Parliament and Council Directive 98/8/EC concerning the placing of biocidal products on the market.

SUBSTANCE: the Directive concerns a wide range of types of products (which are listed in Annex V to the Directive): disinfectants, preservatives, pest control products and antifouling products. It lays down a Community legislative framework of procedures and conditions for authorization enabling the national competent authorities to decide whether to authorize a product after assessing the technical information submitted by parties interested in placing biocidal products on the market. Once authorized in one Member State, a product must be mutually recognized and therefore authorized in any other Member State. As regards substances which serve as active ingredients of biocidal products, the Directive institutes a system of Community authorization. By means of positive lists, these substances are to be authorized as the occasion arises over a period of 10 years, after their risks have been assessed, and subject to any limits on their use to allow their inclusion in biocidal products.

ENTRY INTO FORCE: 14/05/1998

DEADLINE FOR TRANSPOSITION: 14/05/2000.

Commissioner Bjerregaard expressed her satisfaction and announced that the Commission would present a new general text on comitology before June 1998.

The rapporteur stressed the effects of chemical products on human health and particularly highlighted the findings made with regard to the diminishing quality of male sperm. Mrs Jensen particularly deplored the attachment to the proposal, during second reading, of two new annexes whose content was unknown. She condemned the fact that, as a result of this manoeuvre, Parliament would have to accept framework provisions with governments being able to choose the most appropriate solution in terms of how to implement these. Replying to the criticisms made about the lack of transparency, Commissioner Bjerregaard explained that the annex’s wording would be based on a complete risk assessment. The problem was complex as it did not just relate to environmental proposals. Of the 41 amendments tabled, 21 were acceptable to the Commission.