0019Union authorisation of Biocidal products (Chapter VIII

http://ec.europa.eu/environment/chemicals/biocides/index_en.htm

Union authorisation of Biocidal products (Chapter VIII)

General principles

The possibility to authorise at Union level certain products is intended to enable holders of Union authorisation to place their biocidal products directly on the entire Union market.

·         The centralised authorisation procedure will result in a Union authorisation which will entitle the relevant products to be placed on the market anywhere in the Union without the need to obtain separate national authorisations or going through the mutual recognition procedure.

·         The Union authorisation will confer the same rights and obligations in each Member State as an authorisation issued by the competent authority of that Member State.

This Union or centralised procedure will be one of two procedures available to industry to obtain a product authorisation. The Commission will grant authorisations on the basis of an ECHA opinion.

Provided that they have similar conditions of use across the Union, the following products will be eligible to the centralised procedure:

·         From 1/9/2013, all products containing new active substances and products belonging to product types 1, 3, 4, 5, 18 and 19;

·         From 1/1/2017, products belonging to product types 2, 6 and 13;

·         From 1/1/2020, products belonging to the remaining product types;

Products belonging to product types 14, 15, 17, 20 and 21 are however excluded from the scope of Union authorisation, as well as products containing active substances meeting the exclusion criteria.

The system of centralised authorisation remains, however, completely voluntary. If, for whatever reasons (e.g. intention to market only in few Member States), the applicant is not interested in the centralised authorisation scheme, he can apply for a national authorisation of the concerned product. In such case, the provisions on mutual recognition will be applicable.

Procedure

·         Applications for Union authorisations will be submitted to ECHA.

·         The applicant will choose the competent authority which shall be responsible for the evaluation of the application (hereinafter referred to as 'the evaluating competent authority').

·         The evaluation of the application will be done by the evaluating competent authority (12 months).

·         ECHA will prepare an opinion on the conclusions of the evaluation prepared by the evaluating competent authority (6 months).

The opinion of ECHA will be prepared by the Biocidal Products Committee, whose members are appointed by the Member States.

·         The Commission will eventually adopt a decision granting the Union authorisation (implementing act) on the basis of ECHA opinion.

The centralised procedure compared to mutual recognition

The centralised procedure is expected bring the following advantages:

·         the costs of a Union authorisation will be lower than the costs of a single national authorisation combined with the costs of a mutual recognition procedure;

·         the time for issuing a Union authorisation will be similar to the time needed to issue a single national authorisation followed by the mutual recognition;

·         nstant access to the markets of 27 Member States, which will have a positive impact on the product availabilitywhich would hopefully be improved;

·         benefits to health and the environment as the assessment at the Union level will improve the overall consistency.

Pre-submission to ECHA

The Commission also adopted a Note for Guidance on similar conditions of use, which defines a biocidal product with similar conditions of use as a product for which it is not likely, at the time of application for authorisation, that one of the grounds indicated in points (a)-(e) of Article 37(1) of BPR would be fulfilled in one or more Member States.

In accordance with this guidance, applicants for Union authorisation are expected to make a pre-submission to ECHA, at the latest 6 months before the submission of their applications.

The purpose of this pre-submission it to allow a consultation of Member States and to give them the possibility to indicate whether they are likely to advance one of the grounds listed in points (a)-(e) of Article 37(1) of BPR. It will also allow the Commission to analyse whether the objections are likely to be well founded.

For further details see: CA-Feb13-Doc.5.1.e - Final - Note for Guidance on similar conditions of use.doc

NEWSLINKSREACHBIOCIDESEndocrine Disruptors

Note for Guidance

on the

Definition of Similar Conditions of Use across the Union

1.          Executive summary

It is proposed to define a biocidal product with similar conditions of use as a product for which it is not likely, at the time of application for authorisation, that one of the grounds indicated in points (a)-(e) of Article 37(1) of BPR would be fulfilled in one or more Member States.

It is proposed to request applicants for Union authorisation to make a pre-submission to ECHA, allowing Member States to indicate whether they are likely to advance one of the grounds listed in points (a)-(e) of Article 37(1) of BPR, and the Commission to analyse whether the objections are likely to be well founded.

2.          Document background and purpose

According to Article 42(2) of Regulation No 528/2012 (hereinafter 'BPR'), the Commission shall, by 1 September 2013, draw up guidance documents on the definition of "similar conditions of use across the Union". The interpretation of this definition will be of great importance, since it will be decisive for the eligibility for Union authorisation of biocidal products.

This document has been drafted by the Commission services responsible for biocidal products with the aim to agree, to the extent possible, with Member States' competent authorities and other stake holders about the definition in question before the Commission's position is formalised.

The document proposes criteria as well as a procedure for the identification of products with similar conditions of use.

3.          Justification for the proposed criteria for 'similar conditions of use'

Union authorisations granted under BPR will, in principle, be valid in all Member States subject to the same terms and conditions. That is why, according to Article 42(1) of BPR, only products which have "similar conditions of use across the Union" are eligible.

BPR does not describe this concept. However, points (a)-(e) of Article 37(1) of BPR appear to provide a relatively exhaustive list of grounds based on which different conditions of use could be justified.

Evidence of this can be found in the first sentence of Article 42(1) of BPR, which excludes certain product-types ('PTs') from the scope of the Union authorisation. The excluded PTs cover products which are banned in certain Member States, or for which harmonisation of the conditions of use have proven particularly difficult in the mutual recognition procedure, for reasons similar to those listed in points (a)-(e) of Article 37(1) of BPR.

Points (a)-(c) of Article 42(1) of BPR list the eligible PTs, and recital 26 of BPR describes those PTs as "categories of biocidal products with similar conditions of use in all Member States". It can therefore be concluded that the PTs generally believed to require different conditions of use across the Union have already been identified and excluded from the scope of Union authorisation by virtue of the first sentence of Article 42(1) BPR itself.

Further evidence can be found in the second paragraph of Article 44(5) of BPR, which allows different conditions of use, or even a ban, to be imposed in certain Member States even where a Union authorisation is granted, but only based on one of the grounds listed in points (a)-(e) of Article 37(1) of BPR.

In conclusion, both the exclusion of certain PTs and the reference to "similar conditions of use" in Article 42(1) of BPR should be read as seeking to prevent a situation where Union authorisations are granted with different conditions of use, or even a ban in certain Member States, based on the second subparagraph of Article 44(5) of BPR in combination with Article 37(1) of BPR. The possibility in Article 44(5) should be seen as an extra safeguard for Member States to adjust conditions or ban products, while allowing Union authorisations to be granted where applications for such authorisations have been accepted.

Therefore, a biocidal product with similar conditions of use should be defined as a product for which it is not likely, at the time of application for authorisation, that on one of the grounds indicated in points (a)-(e) of Article 37(1) of BPR would be fulfilled in one or more Member States.

The legislator did not choose to exclude from Union authorisation all products which are subject to comparative assessment. Therefore, such products are also eligible, although national variations in the availability of adequate alternatives, as referred to in Article 23(3) of BPR, will be of relevance for justifications based on one of the grounds indicated in points (a)-(e) of Article 37(1) of BPR.

For products which are subject to a comparative assessment and also eligible for Union authorisation, the comparative assessment will have to be organised at Union level. Where it shows that adequate alternatives exist in certain Member States and not in others, adjustments or bans will have to be decided based on one of the grounds indicated in points (a)-(e) of Article 37(1) of BPR in accordance with the second subparagraph of Article 44(5) of the Regulation.

4.          Details of the proposed procedure for the identification of products with similar conditions of use

4.1.1.          Point of departure

Since the PTs generally believed to require different conditions of use have already been identified and excluded from the scope of Union authorisation by virtue of the first sentence of Article 42(1) of BPR, the point of departure for other PTs should be that products belonging to them can have similar conditions of use.

4.1.1.          General submission of information by Member States

For products containing an active substance which is a candidate for substitution, the public consultation of third parties provided for by Article 10(3) of BPR provides a first opportunity for Member States to reverse the presumption where relevant, by indicating whether they have alternative products complying with points (a) and (b) of Article 23(3) of BPR. Member States should therefore systematically notify ECHA of the availability of alternatives on the occasion of the public consultation foreseen under Article 10(3) of BPR. Biocidal products subject to comparative assessment should not be regarded as having 'similar conditions of use' if it is clear already at the time of submission of an application for Union authorisation that the comparative assessment would lead to different conditions of use from one Member State to another.

Furthermore, Member States are invited to inform the Commission about any general circumstances which could justify derogation in accordance with Article 37 of BPR.

4.1.2.          Applicant pre-submission

At the latest 6 months before the submission of its application, a prospective applicant for Union authorisation should submit to the Agency through the R4BP a draft of the summary of the product characteristics for which it intends to submit an application for Union authorisation.

This pre-submission, and the subsequent procedure, will not only serve the purpose of obtaining the confirmation required in accordance with Article 43(1) of BPR that the product would have similar conditions of use, but can also serve to seek confirmation that the product falls within the scope of BPR, and to identify the appropriate PT. Hence, such issues should not need to be discussed further during the Union authorisation procedure itself.

As the definition of which uses belong to which PT may remain an issue, it is critical that this and other scope issues are fully addressed and agreed by Member States competent authorities and the Commission before submission of the application. This will be especially important when the biocidal product has not been considered during the approval process for the active substance; when the active substance is approved for use in more than one PT; when the product contains substances with different functions (e.g. combination of a repellent and of an insecticide, of a wood preservative and an insecticide); or when uses may be near the borderline between different but similar PTs, e.g. PT 2, 3 and 4.

Differences between Member States in their consideration of the scope of a PT is not an argument to support that a product has different conditions of use. In case of such differences, the Commission should be requested to take a decision in accordance with Article 3(3).

4.1.3.          Consultation of Member States

Upon receipt of the draft of the summary of the product characteristics, the Agency will notify Member States competent authorities and the Commission that it has received a pre-submission to an application for Union authorisation and make available to them the draft of the summary of the product characteristics.

The purpose of this notification is to allow Member States competent authorities and the Commission to verify that the product fall within the scope of BPR, that it has been attributed the correct PTs and that Member States would not have well-founded grounds preventing the conditions of use of the product from being similar across the Union.

Where a Member State or, as the case may be, the Commission considers that the product does not fall within the scope of BPR, that the product has not been attributed the correct PTs or that it has well-founded grounds to request a derogation in accordance with Article 37 of BPR, it should inform the Agency, the Commission and the other Member States within 30 days of the notification being made.

Where neither a Member State, nor the Commission reacts within 30 days to the notification of the Agency, the product should be deemed to have similar conditions of use and to be eligible for Union authorisation.

Where a Member State, or as the case may be the Commission,  reacts within 30 days to the notification of the Agency, the confirmation as to whether the product should be deemed to have similar conditions of use and to be eligible for Union authorisation will require further discussions.

4.1.4.          Objections to the scope

Where it is contested that the product falls within the scope of BPR, or that it has been attributed the correct PTs, the matter should be discussed between Member States, with a view to find an agreement.

When no agreement can be found, a Member State, and in particular, the Member State having first raised the matter, should request the Commission to take a decision on the matter in accordance with Article 3(3).

4.1.5.          Objections on the basis of grounds referred to in Article 37

In case a Member State believes that it will have well-founded grounds to request a derogation in accordance with Article 37 of BPR, it should inform ECHA accordingly and provide a justification for its objection.  

4.1.6.          Feedback to the applicant

The Agency should inform the prospective applicant of the outcome of the pre-submission consultation within 180 days of the submission of the SPC by the applicant.

Where relevant, the Agency should confirm to the applicant that neither a Member State nor the Commission has objected that product would fall outside of the scope of the BPR, have been attributed the correct PTs, or have non-similar conditions of use. The applicant can refer to the confirmation from the Agency at the time of the submission of the application in accordance with Article 43(1). This confirmation will however be without prejudice to requests that Member States may address to the Commission to adjust certain conditions of the authorisation for their territory, or to decide that the authorisation does not apply in their territory, in accordance with the second paragraph of Article 44(5), in particular when products contain substances candidates for submission and must undergo a comparative assessment in accordance with Article 23.