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The BPR (EU) 528/2012 provides a number of transitional measures to facilitate the transition from the system of the Directive to that of the Regulation. The transitional provisions laid down in Article 89 of the BPR (EU) 528/2012 allow biocidal products containing an active substance included in the Review Programme (for a given product-type) are subject to national law and will be placed on the market and used by a continuation of national rules.

A product authorisation under transitional legislation is valid in the Netherlands. If you would like to place your product on the market in other Member States, you must determine the regulations for authorisation in those Member States. Authorisations granted under transitional legislation in other Member States are not of any relevance for product approval in the Netherlands.

The national authorisation under transitional legislation is a regular and self containing authorisation, so it does not depend on other authorisations. Therefore the national authorisation under transitional legislation can be subject to change or amendment of the product authorisation or extension of the product authorisation. The authorised product can function as reference product for ‘derived’ authorisations or as source for a parallel trade permit.

After approval of the (last) active substance(s) in a product, a product authorised under transitional legislation is subject to re-registration. Re-registration relates to the evaluation, following the approval of an active substance under the BPR (EU) 528/2012 of biocidal products containing that active substance in accordance with the requirements on product authorisation set by the BPR. When an application for re-registration is submitted, a product may stay on the market up to three years after the date of the substance approval (shorter timeframes apply in case of non-approval).

When at the expiry date of the product authorisation, the active substance is still under review, an application has to be submitted for the biocidal product to postpone the expiry of the approval period (administrative extension of duration period PPP authorisation).

The Legal basis

The national authorisation under transitional legislation finds it legal basis in article 89(2) or article 93 of the BPR (EU) 528/2012. These articles state that for these products a Member State may continue to apply its current system or practice of making available on the market and using a biocidal product, which refers to national law, being the ‘Wet Gewasbeschermingsmiddelen en Biociden’ (Wgb).

Transitional measures concerning the authorisation of biocidal products with active substances under review for that product type in the EU review programme find a legal basis in article 89(2) of BPR (EU) 528/2012, jo article 130a(4) Wgb, jo article 4(2) Wgb (old), jo article 121 Wgb (old), jo article 44 Wgb (old).

Transitional measures concerning the authorisation of biocidal products not covered by the scope of the BPD 98/8/EC find a legal basis in article 93 of BPR (EU) 528/2012, jo article 130a(4) Wgb, jo article 4(2) Wgb (old), jo article 121 Wgb (old), jo article 44 Wgb (old)

Application type criteria

The transitional provisions laid down in Article 89 of the Biocidal Product Regulation (EU) 528/2012 allow a Member State to continue to apply its current system or practice of making available on the market, provided that the active substance/product type combination is included in the Review Programme.

For a biocidal product with multiple active substances, transitional measures apply if at least one active substance is included in the review programme whereas the other active substances already are approved.

To check which substance/product type combinations are included in the Review Programme and still under review, please refer to the ECHA database on biocidal active substances.

From 1 September 2015, a biocidal product can be sold on the EU market only if the manufacturer or supplier of the relevant substance in the biocidal product, or the manufacturer or supplier of the biocidal product for the applicable product type, is included on the Article 95 list of the Biocidal Products Regulation.

See ECHA for additional information about the procedure for being included on the Article 95 list is available on the website of ECHA.

An application under transitional legislation can be submitted until 78 weeks before the approval date of the (last) active substance under the BPR for a regular authorisation, or until 90 days before approval date for a minor change.

Duration period product authorisation

For products approved under transitional legislation, the expiry date of the approval is usually set to 10 years after approval by the Ctgb. However, if all active substances in the product are approved within this period, an application for reregistration should be submitted to ECHA before the date of approval of the active substance. By doing this, the product can remain on the market for a maximum of 3 years or until a decision is taken for the application under the BPR. The date for approval of an active substance is announced approximately 2 years in advance. Check the ECHA database on Biocidal Active Substances.

Data Requirements

The transitional provisions laid down in art. 89(2) and art. 93  of the BPR (EU) 528/2012 allow that biocidal products based on an existing active substance(s) under review for that product type in the EU Review programme are subject to national law pending the final decision on the approval of the active substance. The plant protection products and biocidal products act (Wet gewasbeschermingsmiddelen en biociden, abbreviated as Wgb) art. 130(a) defines with regard to these product applications that the Wgb and underlying legislation stays into force as was before 21-11-2013.

The minimal data requirements concern a dossier containing the information needed to assess that the product under the proposed Legal Conditions for Use and the Directions for Use (WG/GA) is sufficiently effective and that no unacceptable risk is expected to human health, the person who uses the product, and the environment. The legislative framework on data requirements for biocidal products authorised under transitional legislation is described in the articles listed below.

Technical guidance on the evaluation of biocidal products is available in the ‘Evaluation Manuals’, published on the Ctgb website. The Evaluation Manual concerns both the European and the national requirements for the authorisation of biocidal products and provide a work instruction for the assessment of risks. European requirements refer to the assessment framework set by guidance under the legislation, where as the national requirements to national aspects.

European bodies

Authorisations under transitional legislation concern the continuation of national practices applied before the introduction of the BPR (EU)528/2012. Therefore European bodies are of no influence on this legislative frame work.