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The Process of the review of the active substance

In the previous article, we explained about the current situation of the dossier on geraniol, active substance in Product Types (PT) 18 and 19. We also briefly described the “alternative” approach followed by TerpeneTech to become an article 95 listed active substance supplier. We will now focus on the standard approach to get active substances for biocides approved.

What was the procedure under the BPD (Biocidal Products Directive, 98/8) and now under the BPR (Biocidal Products Regulation 528/2012) replacing the BPD?

We have to go back into time! The COMMISSION REGULATION (EC) No 2032/2003 of 4 November 2003 specified the details and submission dates for the dossiers on the active substances and for the insecticides (PT 18) and repellents (PT 19). This was between 1 November 2005 and 31 April 2006. The Rapporteur, the member state responsible for the evaluation, for geraniol in both PT’s is France.

The process under the BPD is no longer relevant, therefore, we focus on the current standard procedure of the BPR. This procedure can be divided in 3 phases: validation, evaluation and decision making.

VALIDATION

The applicant submits a dossier via the R4BP (Register for Biocidal Products) to the Agency, ECHA. Data input in IUCLID (International Uniform ChemicaL Information Database) and reports attached as PDF’s. A “Word”-template “Assessment Report” needs to be submitted and a confirmation of a member state accepting to evaluate the dossier, the evaluating Competent Authority or eCA, needs to be included.

Following the submission, ECHA provides an invoice for the fee, payable to ECHA within 30 days.

Following payment, the eCA will be asked to issue an invoice for the evaluation, also to be paid within 30 days to the eCA this time and, following receipt of the payment, the eCA has to validate the application within 90 days.
If the dossier is considered incomplete, the applicant will be allowed a maximum of 90 days to complete it.

EVALUATION

When the dossier is complete, the evaluation will start and the eCA has 365 days or one year to complete this work. If, during the evaluation further information is required, the applicant will be allowed a maximum of 180 days to submit it. At the end of the evaluation period the applicant will receive the “draft Assessment Report” (draft AR) and has 30 days to comment.

The draft AR is submitted to the Agency and review of this document is then scheduled for discussion in the BPC Working Groups (Biocidal Products Committee WGs). There are 4 permanent WGs: Efficacy, – Analytical Methods and Physico-chemical Properties, Human Health and Environment.

In the WGs scientific/technical aspects can be discussed and agreed upon.

DECISION MAKING

The active substance is scheduled for a “general” BPC meeting when all technical/scientific aspects have been accepted, normally around 6 months after the WGs. A BPC-opinion is discussed and adopted. In this BPC meeting an opinion is made related to the (non) approval of the active substance for use in biocidal products and its conditions and potential restrictions.

BPC-opinions are made publicly available on the ECHA website within a month following the meeting. Based on this opinion, the Commission prepares a Commission Implementing Regulation (CIR), a legally binding document related to the (non) approval of the active substance specifying approval and expiration dates, PTs where the substance can be used and potential restrictions and conditions for biocidal products based on the substance.

The CIR, also called the approval regulation, is voted on in the Standing Committee for Biocidal Products (SCBP), around 6 months following the publication of the BPC-opinion and published in the EU Official Journal shortly afterwards. Around the same time the full “Assessment Report” will be made publicly available on the ECHA website.

For existing active substances, like geraniol, the approval date will be around 2 years after the BPC opinion is published and the approval period will be normally 10 years.

WHAT DOES THIS MEAN FOR YOU?

Why allow 2 years between the BPC-opinion and the approval date?

Because the formulators of the biocidal products, based on the active substance, need time to prepare their dossier(s). And as part of a product dossier is risk assessment, detailed information on the active substance is required and this is only available in the Assessment Report! So, in principle, a formulator has only some 18 months to prepare his product dossier(s).

From submission of the active substance dossier to the final approval is a process taking several years! Due to the inclusion of evaluating the active substances also in relation to the established “Endocrine Disruptor” criteria further delays are build up and we see a decrease in the number of BPC-opinions. Initially ECHA expected 50 opinions per year but in 2018 less than half have been adopted!

Is this good or bad for industry?

Rather good as member state competent authorities have to manage hundreds of biocidal product dossiers of existing products on the market of already approved active substances. And when, let’s say, 40 approvals are adopted (and 10 non-approvals) in a year, it means that two years later biocidal product dossiers are submitted. And, be assured that for certain active substances this number goes into the thousands. So, member states are not unhappy that less dossiers will come with a slow down of the decision making in the BPC!

And for you, it means that you have more time to sell our products under the less restrictive rules today and have also more time to prepare your biocidal product dossiers!

In the next newsletters, we will focus on different aspects of biocidal products dossiers and how they are evaluated under the BPR.