Regulations

Latest developments

On 4 December 2007, the Commisssion adopted Regulation (EC) No 1451/2007 , which repeals Regulation (EC) No 2032/2003 and entered into force on 31 December 2007.

Most of the operational provisions of Regulation (EC) 2032/2003 remain essentially the same, save for minor adaptations (changes in numbering; adaptation of references to other Articles or Annexes; etc.).

In essence, the major amendments to the regulatory content of Regulation (EC) 2032/2003 concern the following:

1. Introduction of a new Article 6 regarding the placing on the market of food or feed as attractants or repellents for harmful organisms (e.g. fruit jam in sticky fly traps). There is a general agreement among Member States that the risk that these products present for health or the environment is practically nonexistent, and therefore it is not justified that they should come within the scope of the Directive. However, until this interpretative approach is unequivocally confirmed by the Directive in its upcoming revision, and in order to ensure until then an adequate level of legal certainty for stakeholders and a harmonised treatment of these products in the internal market, it is considered necessary to dispense them from review for as long as the current provisions of the Directive would allow (i.e. for the duration of the review programme). In order to discourage abuse of this provision, its scope does not include extracts or substances isolated from food of feed products.

2. The provisions of Article 12 regarding the conditions for taking over the role of participant for an active substance notified for evaluation within the review programme when all participants 'defending' the substance have withdrawn and no other operator or Member State expressed an intention to replace them. This provision is amended in two respects:

a) the simple announcement to the Commission that a person intends to take over the role of participant will no longer be sufficient for the substance to remain within the review programme (and on the market) and for the person to automatically acquire the quality of participant to the review programme; they will also have to demonstrate to the Commission a real commitment to have the active substance evaluated, in the form of proof that they have at least commissioned the studies necessary for a complete dossier.

b) in order to avoid companies successively replacing one another in the sole purpose to keep the active substance within the review programme and on the market, without ever submitting a complete dossier for its evaluation, we propose that only one replacement of the initial withdrawn participant(s) should be allowed and the deadline to submit a dossier with information for the assessment of the substance should be extended only once.

This measure has been considered necessary after the majority of companies that took over from withdrawn participants (and were granted a substantial deadline extension by the Commission to present a complete dossier) have failed themselves to deliver the information required for the assessment of the active substances concerned. Industry representatives have also pointed out, in a number of occasions, the unequal treatment between the initial notifiers that had to compile and submit a notification dossier in order to have their active substances assessed within the review programme and persons that are now allowed to take over from them and become participants with a simple announcement to the Commission.

3. Article 4b of Regulation (EC) 2032/2003 is deleted as obsolete. This Article was giving the possibility to interested operators to join exceptionally the review programme if they submitted a complete dossier for an active substance/product type combination before 1.3.2006.

4. The ex-Article 14 'Amendments to Regulation (EC) No 1896/2000' was removed as it has produced its legal effect in the past

5. The rationalisation of the Annexes to Regulation (EC) 2032/2003 concerns the following:

- Annex III is deleted - biocidal products may only contain active substances that are either under review and listed in Annex II of Regulation (EC) 1451/2007 or are already included in the Directive's positive list;

- in this Annex II a new column is added with the Rapporteur Member States designated to carry out the review of the active substances concerned, while the deadlines for submitting complete dossiers for each product-type are now laid down in Article 9 (ex-Article 7); Annex V which was listing these two elements is deleted;

- Annex IV - 'requirements for the complete dossier and the summary dossier' becomes Annex III;

- Annex VI - 'competent authorities' contact details', is deleted as it always contained outdated information and will be replaced by a similar but updated list published on the Commission's web site;

- Annex VII - the above-mentioned 'forgotten' substances that were identified in 2005, is deleted and the relevant entries will be moved either to Annex I - 'identified substances', or to Annex II - 'substances under review', provided that a complete dossier was submitted for them before 1.3.2006 in accordance with Article 4b of Regulation (EC) 2032/2003;

- finally, Annex VIII is also deleted as obsolete: the entries of active substances for which a complete dossier was submitted within the new deadline granted to the person(s) that took over the role of participant are transferred to Annex II; entries of other active substances for which no dossier was submitted by the persons that took over the role of participant are deleted (of course they remain identified active substances and as such are listed in Annex I to Regulation (EC) 1451/2007).

Previous developments

The first phase of the review program was established by Commission Regulation (EC) 1896/2000 . Producers and formulators had to either identify or notify all existing active substances to the European Chemicals Bureau before 28 March 2002. Commission Regulation (EC) No 1687/2002 lays down an additional period for notification of identified existing active substances. Time limit for these additional notifications is 31 January 2003.

Active substances used in rodenticides or in wood preservatives will be assessed first. Those who have notified these substances, have to submit the supporting documentation before 28 March 2004.

The second phase of the review program was established by Commission Regulation (EC) 2032/2003 . This so-called second Review Regulation contains:

the exhaustive list of identified existing active substances
the exhaustive list of notified existing active substances and the product types in which they were notified
phase-out periods for substances that are only identified and of notified substances for those product types not notified
the prioritisation of the product types in the review program
the allocation of the Rapporteur Member States for the substances
details on the submission of the dossier, the evaluation and the corresponding procedures

This Regulation has been amended by Commission Regulation (EC) 1048/2005 . This so-called third Review Regulation introduces the following amendments:

It lays down the concept of essential use, whereby Member States may apply to the Commission for an extension of the 1 September 2006 deadline where they consider that an active substance which should be removed from the market on that date is essential for them for reasons of health, safety, protection of cultural heritage or is critical for the functioning of society, and where there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.
It extends the 1 September 2006 deadline for certain substances, under the condition that a complete dossier will have been submitted to the competent authorities of a Member State by 1 March 2006 at the latest. These substances are substances that were only identified and notified substances, for product types not notified.
It updates among others the list of notified existing active substances and the product types in which they were notified, taking into account all withdrawals and cases where no dossier was submitted.
It allocates Rapporteur Member States for the substances of the 3rd and 4th priority lists, which had not yet been allocated.

Regulation (EC) 2032/2003 was further amended by Commission Regulation (EC) 1849/2006 . This Regulation introduces the following amendments:

It lays down the concept of 'assessment report', which is the final form of the report on the evaluation carried out by the Rapporteur Member State; once the competent authority report has been peer reviewed and the evaluation completed. It also lays down that the assessment report shall be made publicly available.
It stipulates that, after 1 September 2006, biocidal products containing substances, for which decisions will have been taken to no longer include them within the review programme, shall be withdrawn from the market within 12 months of such decisions coming into force.
It updates annexe III of Regulation 2032/2003 to remove the entries of the BKC- / DDAC-related substances, which are thus allowed to remain on the market, for the product-types notified, after 1 September 2006 and until they have been evaluated under the review programme.
It updates annexes II and III of Regulation 2032/2003 further to the submission of applications in accordance with Article 4b of Regulation 2032/2003.