Review Regulations


Review Regulations :

The Review Programme for active substances covered by Regulation 528/2012 is controlled by a series of Commission Regulations which set out the procedures and timescales for the programme. These are the Review Regulations. (1) 1st Review Regulation - 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. It describes the notification procedure of existing active substances. (2) Prolongation Regulation - 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. (3) 2nd Review Regulation - Commission Regulation (EC) No 2032/2003 of 4 November 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, and amending Regulation (EC) No 1896/2000. The 2nd Review Regulation gives the outcomes of the notification and identification procedures as lists of substances and the product types in which they have been nominated. (3) 3rd Review Regulation - Commission Regulation (EC) No 1048/2005 of 13 June 2005 amending Regulation (EC) No 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. This Regulation: amends the Second Review Regulation (EC) No 2032/2003; gives the third (Part C) and fourth (Part D) priority lists and the associated Rapporteur Member States; gave the opportunity for an active, which was only identified, or one that had been notified but not for use in the particular product type you are interested in, to be upgraded to the 'notified' status by submitting a full dossier for review on the active substance and a representative product containing it, to a Member State Competent Authority by 1 March 2006. (This method of entering the review process is set out in article 4b of the Third Review Regulation); 4th Review Regulation - Commission Regulation (EC) No 1849/2006 of 14 December 2006 amending Regulation (EC) No 2032/2003 concerning 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. It amends the lists of active substances on Annexes II, III, V and VII of the second Review Regulation requires the Rapporteur Member State to produce an 'assessment report', based on their competent authority report for a reviewed substance, and that the Commission will make this assessment report publicly available requires that when a decision is taken not to include a substance in the Directive's Annexes, Member States ensure products containing that substance are no longer on the market with effect from 12 months after the date of the decision coming into effect. 5th Review Regulation - Commission Regulation (EC) No. 1451/2007/EC came into effect on the 24 December 2007. It updates and replaces the Second Review regulation (2032/2003/EC and its amendments (1048/2005/EC and 1849/2006/EC (the Third and Fourth review regulations. The main changes this regulation makes are: It allows for the removal from consideration of Animal and Human foodstuffs marketed as Attractants or Repellents (product type (PT) 19, i.e. honey, jam) until the end of the end of the review period, at present 14th May 2010. When a non-inclusion decision has been published for a substance in a particular product type, then from the date of publication there is a 12 month phase out from sale period. (See: Article 4 (2). Also when support has been withdrawn for a substance in the review programme, it states that it can be taken over by another participant. This must happen within the 3 month period as outlined by the Commission. This change of support can only happen on one occasion. (See: Article 12). So if you have an interest in taking over support of a substance, you must do it within this 3 month period otherwise it will be withdrawn from the review process and would then have to be treated as a new active. Where a substance is supported through the review, others apart from the original Applicant may submit dossiers to support the active. However, they will have to work to the same timescale as the original submission. (See: Articles (7) and (8). Also the regulation provides updated and simplified Annexes for existing chemicals, the Member States responsible for evaluation and the product types that support has been registered under. The 5th review regulation should now be used to check substance notification under the review programme as it replaces previous review regulations

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