Annex I amendment
Active substances that can be contained in biocidal products eligible for simplified authorisation procedure
Annex I of the Biocidal Products Regulation (BPR) lists initially active substances identified as presenting a low risk under Regulation (EC) No 1907/2006 or Directive 98/8/EC, substances identified as food additives, pheromones and other substances considered to have low toxicity, such as weak acids, alcohols and vegetable oils used in cosmetics and food. Other active substances may be added provided that there is evidence that they do not give rise to concern.
To encourage the use of products with a more favourable environmental, human or animal health profile, biocidal products containing one or more of these active substance(s) are eligible for a simplified authorisation procedure.
This procedure can be initiated by the Commission at its own initiative or at the request of an economic operator (based in the EU or not) or a Member State providing that the necessary data requirements are submitted.
The BPR establishes the criteria to identify substances that do not give rise to concern while Commission Implementing Regulation (EU) No 88/2014 establishes the procedure for the submission by companies of requests for the amendment of Annex I of the BPR (first inclusion of an active substance or amendments to the relevant restrictions) and their subsequent evaluation.
Data requirements for an application for the amendment of Annex I to the BPR (first inclusion of an active substance or amendment of restrictions)
Regulation (EU) No 88/2014 specifies the data requirements for categories 1 to 5 and 6.
Applicants seeking to include an active substance in categories 1, 2, 3, 4 or 5 of Annex I of the BPR must submit an application through R4BP 3 specifying and providing:
- evidence to demonstrate that the substance complies with the description of the relevant category in which they are seeking the inclusion,
- the identity of the substance and the intended uses of the products for which an authorisation will be sought,
conclusive evidence to demonstrate that there is a robust consensus of expert opinion that the substance does not give rise to concerns such as:
meeting the criteria for classification according to Regulation (EC) No 1272/2008 as:
- explosive/highly flammable,
- organic peroxide,
- acutely toxic of category 1, 2 or 3,
- corrosive of category 1A, 1B or 1C,
- respiratory sensitiser,
- skin sensitiser,
- germ cell mutagen of category 1 or 2;
- carcinogen of category 1 or 2,
- human reproductive toxicant of category 1 or 2 or with effects on or via lactation,
- specific target organ toxicant by single or repeated exposure, or
- toxic to aquatic life of acute category 1;
- fulfilling any of the substitution criteria set out in Article 10(1); or
- having neurotoxic or immunotoxic properties.
- meeting the criteria for classification according to Regulation (EC) No 1272/2008 as:
Active substances also give rise to concern even if none of the specific criteria listed above are met but a level of concern equivalent to that arising from those criteria can be reasonably demonstrated, based on reliable information.
This evidence must include all relevant published literature data regarding the substance in question and all relevant data on the substance generated by the applicant.
It may also include read-across from chemical analogues and homologues, (Q)SAR predictions, data from existing studies, in vitro studies, historical human data, or conclusions from other regulatory authorities or frameworks.
Where there is no conclusive evidence of a robust consensus of expert opinion regarding one or more endpoints, an application shall contain all additional data necessary to show that the substance does not give rise to the concerns listed above.
Applicants seeking to include an active substance in category 6 of Annex I of the BPR must submit a dossier containing a data package through R4BP 3, equivalent to those submitted for active substance approvals (see Article 6 of the BPR), allowing a full risk assessment for the intended use.
For the time being the Commission has not specified the data requirements and procedure to amend category 7 of Annex I of the BPR.