Simplified Actives Substances under EU Biocides Regulation 528/2012 (EU BPR)
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
This page provides information on Simplified Active Substances under the EU Biocides Regulation 528/2012 (EU BPR) This page does not provide information on the Simplified Authorisation procedure for product in the UK.
The use of products, which are considered t have a more favourable environmental or human or animal health profile is encouraged. One of the measures that was introduced in the EU BPR to fulfil this objective is to provide for simplified authorisation procedures for specific products that are expected to present such characteristics.
Among other criteria, such products should contain only active substances that are listed in Annex I of EU BPR. The legislators chose to limit this list initially to 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. This list is limitative, and some substances are already listed in those categories. The Commission is empowered to modify Annex I by delegated acts, in order to include, restrict or remove the entry of a substance in that Annex.
Criteria applicable to an active substance in order to be listed in Annex I
Specific criteria are defined in EU BPR concerning the properties that active substances shall not have to be listed in that Annex. According to Article 28(1) and (2), active substances can be included in Annex I if there is evidence that they do not give rise to concern.
A substance is considered to give rise to concern where:
(a) it meets 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;
(b) it fulfils any of the substitution criteria set out in Article 10(1) [substitution criteria]; or
(c) it has neurotoxic or immunotoxic properties.
An active substance also gives rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.
Once an active substance in Annex I of EU BPR companies can apply for authorisation of simplified products.
The EU Commission has published an Implementing Regulation (Regulation (EU) No. 88/2014), which specifies the procedure for adding to and amending the substances listed in Annex I of the EU BPR.