Substances of Concern

Assessment of Substances of Concern

A substance of concern (SoC) is defined in Art 3(f) of Regulation (EU) No. 528/2012/EC or the Biocidal Product Regulation (BPR) as follows:.

‘Substance of concern’ means any substance, other than the active substance, which has an inherent capacity to cause an adverse effect, immediately or in the more distant future, on humans, in particular vulnerable groups, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect. Such a substance would, unless there are other grounds for concern, normally be:

• a substance classified as dangerous or that meets the criteria to be classified as dangerous according to Directive 67/548/EEC, and that is present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Articles 5, 6 and 7 of Directive 1999/45/EC, or
• a substance classified as hazardous or that meets the criteria for classification as hazardous according to Regulation (EC) No 1272/2008, and that is present in the biocidal product at a concentration leading the product to be regarded as hazardous within the meaning of that Regulation,
• a substance which meets the criteria for being a persistent organic pollutant (POP) under Regulation (EC) No 850/2004, or which meets the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII to Regulation (EC) No 1907/2006;Note that the information requirements for PBT assessment is available in chapter R.11: PBT assessment,

• an active substance, for which a (draft) CAR is available, which acts as co-formulant in the biocidal product,

• a substance that enhance the effect of the active substance in the product,

• a substance that is included on the candidate list (REACH or BPR article 3f).

Therefore, Substances of Concern (SoC) are co-formulants in biocidal products, in addition to the active substance, which can pose a potential risk for humans and the environment. The Biocidal Products Regulation states explicitly that SoCs must be included in the risk assessment.

Further general information about the assessment of SoCs is described at the Ctgb website. There is a guidance document on the assessment of SoCs for the human health risk assessment and for the environmental risk assessment. The SoC guidance for human health toxicology is described in CA-Nov14-Doc.5.11 – SoC guidance_final.doc present on CIRCABC Public Biocides Regulation page. Furthermore, the text of this CA document is included in BPR guidance (Volume III Human Health - Assessment & Evaluation (Parts B+C), version 4.0 December 2017).

Part C of version 2.0 of the updated Guidance on the BPR: Volume IV Environment, Assessment & Evaluation (Parts B+C) dated October 2017 addresses the identification of Substances of Concern in biocidal products. The Ctgb considers it important that the applicant submits relevant information/data for all substances of concern in their product to quantify the environmental risk for the intended uses.

Co-formulants that have been approved or are being assessed in the Review Programme for another product type (PT) than the product type that is applied for, must also be considered as an SoC from the moment onwards that the draft Assessment Report for the other product type has been published.