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Approval of active substances (Chapter II)

Data requirements (Article 6)

The data requirements of the Directive are modified.

First, the principle of proposing and accepting adaptations to the data requirements is formalised and Member States have to inform and if possible assist the applicants with their adaptation requests.

Second, the grounds for data waiving provided for in REACH will apply also for the proposed Regulation.

Third, the core data requirements are modified and certain long-term animal studies are only required when necessary - these are the most costly data requirements, in terms of lives of test animals and in terms of money.

Data requirements are set out in Annexes II and III and distinguish "core data" from "additional data", which are only required when there are indications that a particular (eco)toxicological end-point should be explored further.

The Regulation does also allow a more systematic approach to the waiving of data requirements based on reduced exposure as well as the use of techniques such as read-across, Structure Activity Relationships and calculation methods.

The Regulation also includes provisions for the obligatory sharing of data involving testing on vertebrates in exchange for fair financial compensation.

As the costs of authorisations are largely dependent upon the costs of generating data on the active substance, the extent to which the provisions on data waiving can be used will have a significant impact on the former.

In any event, the data that have to be submitted must be sufficient for the authorities to carry out a proper risk assessment. This also means that the data requirements cannot be reduced on the grounds that the applicant is an SME.

Lastly, unlike REACH, the Regulation does not have any low-volume cut-offs. However, on a case by case basis and taking account of the nature of the product and the expected level of exposure, it will be possible to make a case for a reduced data package on this basis when applying for product authorisation.

Exclusion criteria (Article 5)

The objective of the exclusion criteria is to ensure that the most hazardous active substances (e.g. carcinogens, mutagens, endocrine disruptors, persistent, bioaccumulative and toxic substances) are phased out.

Derogations are however foreseen, in particular when the substance might be needed on grounds of public health or of public interest when no alternatives are available.

Candidates for substitution (Article 10)

The objective of this provision is to identify substances of particular concern to public health or the environment and to ensure that over time these substances are phased-out and replaced by better alternatives.

When a substance is identified as a candidate for substitution, products containing that active substance will have to be subject to a comparative assessment at the time of authorisation (see Article 23) and will only be authorised if there are no better alternatives.

For active substances which will have been approved before 1 September 2013 under the condition of a comparative assessment , the conditions of approval of these substances will be amended  to read: 'In view of the fact that the active substance characteristics render it potentially …, the active substance shall be considered a candidate for substitution in accordance with Article 10'. (1)

The aim of this change is to ensure as much consistency with the Directive as possible while taking into account the changes introduced by Articles 10 and 23 of the new Regulation.

By designating all active substances with relevant characteristics as candidates for substitution it is ensured that a comparative assessment will be carried out for all biocidal products containing them.

The designation as a candidate for substitution has two practical consequences:

  • Shorter inclusion period compared to 'normal' active substances.
  • Comparative assessment has to be carried out for biocidal products containing a candidate for substitution.

(1) See for example entries for difethialone and difenacoum in the Commission proposal for a Regulation, and explanations on Article 86.