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New Biocidal Products Regulation

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms such as pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

The regulation was adopted on 22 May 2012 and is applicable from 1 September 2013, with a transitional period for certain provisions. It repeals the Biocidal Products Directive (BPD, Directive 98/8/EC).

The BPR applies only to legal entities established in the European Union.  Companies established outside of the EU are not bound by the obligations of the BPR, even if they export their products into the European Union. The responsibility for fulfilling the requirements of the BPR, such as the approval of active substances or the authorisation of biocidal products lies in principle with the importers established in the European Union.

The importers in the EU may turn towards their non-EU suppliers and request information that they may need in order to fulfil their regulatory obligations. As a non-EU supplier, you can further support your customers (i.e. importers, established in the European Union) by providing sufficient information to fulfil the obligations of importers under the BPR. As a first step, it is advisable to make yourself aware of the relevant obligations.

SpetsInterProject Oy provides consulting services on new BPR regulation. Below you may get to know about BPR procedures.

Approval of Active Substances

Authorisation of biocidal products

Technical equivalence

List of approved suppliers

Treated Articles

Approval of Active Substances

New active substances

Companies have to apply for approval of an active substance by submitting a dossier to ECHA. After the validation check has been performed by ECHA, the evaluating competent authority carries out a completeness check and an evaluation within one year.

The result of the evaluation is forwarded to ECHA's Biocidal Products Committee, which prepares an opinion within 270 days. The opinion serves as a basis for the decision-making by the European Commission and the Member States. The approval of an active substance is granted for a defined number of years, not exceeding ten years.

A similar process takes place for the renewal of the approval of an active substance, where, depending on the amount of new studies available at the renewal, a distinction is made between a full evaluation and a limited evaluation. The application to ECHA has to be submitted 550 days before the expiry date of the approval.

The BPR introduces exclusion and substitution criteria as new elements.

Exclusion criteria
Active substances meeting the exclusion criteria will not be approved. This includes:

  • carcinogens, mutagens and reprotoxic substances category 1A or 1B according to the CLP Regulation
  • endocrine disruptors
  • persistent, bioaccumulative and toxic (PBT) substances
  • very persistent and very bioaccumulative (vPvB) substances
  • Derogations are foreseen, in particular when the active substance may be needed on the grounds of public health or of public interest when no alternatives are available.

Substitution criteria
Active substances meeting the substitution criteria will undergo a public consultation and may be designated as candidates for substitution during the approval procedure. The criteria are based on the intrinsic hazardous properties in combination with the use and potential exposure.

During the evaluation for national or Union authorisation of a biocidal product containing active substances considered as candidates for substitution, a comparative assessment will be performed to estimate whether less harmful products are available for the same use.

Existing active substances

The provisions in the Biocidal Products Regulation (BPR) will also apply to the applications submitted under the review programme of active substances under the Biocidal Products Directive (BPD). As of 1 January 2014, ECHA takes over the programme from Directorate-General Joint Research Centre (DG JRC) of the European Commission.

Substances which were on the market before 14 May 2000 and are evaluated under the Review Programme are referred to as existing active substances.

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Authorisation of biocidal products

All biocidal products must get an authorisation before they can be made available on the market. Companies can choose between several alternative processes, depending on their product and the number of countries where they wish to sell it.

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Technical equivalence

Technical equivalence is the similarity between two active substances in regard to their chemical composition and hazard profile.

In the assessment of technical equivalence, an active substance is compared to an already approved substance (reference active substance) to determine if they are equivalent.

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List of approved suppliers

The Biocidal Products Regulation (BPR) aims to ensure that the costs of the data on active substances are equitably shared. Therefore, all active substance manufacturers and importers placing active substances on the EU market must contribute to the costs.

Companies that have not already submitted their own dossier on an active substance under the Biocidal Products Directive (BPD) or the BPR must either submit a dossier, a letter of access, or if all data protection periods have expired, a reference to an existing dossier to ECHA. This information must comply with the data requirements of Annex II of the BPR or of Annex II A of the BPD.

ECHA will publish a list of persons who have made a successful submission of the required information (see link to List of active substance suppliers).

From 1 September 2015, a biocidal product cannot be placed on the EU market if the manufacturer or importer of the active substances contained in the biocidal product, or where relevant, the importer of the biocidal product, is not included in the list.

The principles of mandatory data sharing apply, whereby applicants must share and not duplicate studies and tests on vertebrate animals are undertaken as a last resort. In the context of the active substance suppliers list, the principle of mandatory data sharing applies not only to tests involving vertebrate animals but also to all toxicological and ecotoxicological studies not involving tests on vertebrates. The extension of the principle of mandatory data sharing beyond tests on vertebrate animals is only in relation to active substances in the Review Programme and does not apply to new active substances.

Any active substance supplier intending to perform tests or studies may, in the case of non-vertebrate animal tests, and must, in the case of vertebrate animal tests, inquire with the Agency whether such tests or studies have already been submitted to any competent authority or to the Agency under the BPD or the BPR. The Agency will provide the prospective applicant with the contact details of the relevant data submitter. This inquiry step is a pre-condition before any data sharing dispute can be brought before the Agency because the relevant timelines for the dispute procedure are calculated from the date on which the Agency provides the contact details of the data submitter.

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Treated Articles

The BPR sets rules for the use of articles treated with, or intentionally incorporating, one or more biocidal products.

According to the BPR, articles can only be treated with biocidal products containing active substances approved in the EU. This is a change from the BPD, where articles imported from third countries could be treated with substances not approved in the EU, such as wood treated with arsenic.

Companies must also be ready to provide the consumers with information about the biocidal treatment of the article they are selling. If a consumer requests information about a treated article, the supplier must provide it free of charge within 45 days.

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