REACH, CLP and biocides for non-EU companies

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. In addition, the EEA agreement incorporated the BPR by virtue of the Joint Committee Decision adopted on 13 December 2013 and entered into force on 14 December 2013. Pursuant to this Decision the BPR applies also to Norway and Iceland and Liechtenstein. Whenever this webpage refers to the EU, it should be read to cover these three countries too. No agreement has been signed yet between Liechtenstein and Switzerland pending agreement between the EU and Switzerland to apply the BPR in Switzerland.

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 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. This covers mainly the following points:

  • All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must have been previously approved. There are, however, certain exceptions to this principle. For example, active substances under the Review Programme and biocidal products containing these active substances can be placed on the market while awaiting the final decision on the approval. Provisional product authorisations for new active substances that are still under assessment are also allowed on the market.
  • The BPR aims to harmonise the market at Union level, simplify the approval of active substances and the authorisation of biocidal products and introduce timelines for Member State evaluations, opinion-forming and decision-making. It also promotes the reduction of animal testing by introducing mandatory data sharing obligations and encouraging the use of alternative testing methods.
  • As in the previous BPD, the approval of active substances takes place at Union level and the subsequent authorisation of the biocidal products at Member State level. This authorisation can be extended to other Member States by mutual recognition. However, the BPR also provides applicants with the possibility of a new type of authorisation at Union level (Union authorisation).

 

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.

Existing active substances

The provisions in the Biocidal Products Regulation (BPR) will also apply to the applications submitted under the Rreview 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.

You can find further information in the Biocidal Products Regulation section.

 

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.

You can find further information in the Biocidal Products Regulation section.

 

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.

You can find further information in the Biocidal Products Regulation section.

 

Approved suppliers

The BPR aims to make sure that the costs of the assessment of active substances are equally shared. Therefore, active substance manufacturers and importers that were not involved in the review programme or in the original application of an approved active substance, but have nevertheless placed that active substance on the market, must contribute to the costs.

On the other hand, these companies are given a fair chance to purchase access to the data. For this purpose, the principles of mandatory data sharing apply.

You can find further information in the Biocidal Products Regulation section.

 

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.

You can find further information in the Biocidal Products Regulation section.