Question-ID: 226, 301

ID 226 and 301 were both on Substances of (Very High) Concern. As they have related answers, they were combined in the questions above. To better answer the questions addressed by the submitters, it was agreed to change the questions received from ID 226 ‘What is the difference between ‘substances of concern’ and ‘substances of very high concern’ in ESRS E2 Disclosure Requirement E2-5?’ and ID 301 ‘What is the list of substances of high concern to be considered? Is the list of substances of Very High Concern the one in Annex XIV of REACH? What are the main hazard classes of substances of concern and very high concern that must be considered for reporting under paragraph 34?’ to the questions above.

As per Annex II Acronyms and Glossary of Terms, a substance of concern (SoC) is a ‘substance that meets at least one of three criteria:’

(1) ‘meets the criteria laid down in Article 57 and is identified in accordance with Article 59 (1) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH) – this group of substances corresponds to Substances of Very High Concern;

(2) is classified in Part 3 (which lists hazardous substances for which harmonised classification and labelling have been established at Community level) of Annex VI (Harmonised classification and labelling for certain hazardous substances) to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (Regulation on classification, labelling and packaging (CLP) of substances) in one of the following hazard classes or hazard categories:

(a) carcinogenicity categories 1 and 2;

(b) germ cell mutagenicity categories 1 and 2;

(c) reproductive toxicity categories 1 and 2;

(d) endocrine disruption for human health;

(e) endocrine disruption for the environment;

(f) Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties;

(g) Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties;

(h) respiratory sensitisation category 1;

(i) skin sensitisation category 1;

(j) chronic hazard to the aquatic environment categories 1 to 4;

(k) hazardous to the ozone layer;

(l) specific target organ toxicity, repeated exposure categories 1 and 2;

(m) specific target organ toxicity, single exposure categories 1 and 2;

(3) or negatively affects the re-use and recycling of materials in the product in which it is present, as defined in relevant Union product-specific ecodesign requirements.’

The ESRS Glossary defines substances of very high concern (SVHCs) as substances ‘that meet the criteria laid down in Article 57 of Regulation (EC) No 1907/2006 (REACH)’ and that are ‘identified in accordance with Article 59 (1) of that Regulation’.

Following Article 57 of REACH, the substances described below may be identified as SVHC:

(a) under the Regulation (EC) No 1272/2008 (CLP) as: (a) carcinogenic of category 1A and 1B; (b) mutagenic category 1A and 1B; (c) toxic for reproduction category 1A and 1B;

(b) under Annex XIII of REACH as: d) persistent, bioaccumulative and toxic; e) very persistent and very bioaccumulative;

(c) other substances for which there is scientific evidence of probable serious effects to human health or the environment, which give rise to an equivalent level of concern to those other substances listed above, and which are identified on a case-by-case basis, such as those having endocrine disrupting properties.

The list that is relevant for the identification of SVHCs is the ‘Candidate List of substances of very high concern for Authorisation’, which compiles the list of substances that are potential candidates for inclusion in Annex XIV (Authorisation list).

Concerning SoCs, these will include the SVHCs in the lists above (criterion 1) as well as all substances corresponding to criterion 2 – but for which, at this stage, a comprehensive list cannot be presented. Nevertheless, substances regulated under CLP would have information that could allow their assessment as being SoCs. Furthermore, ECHA provides a database to filter Annex VI by specific hazard classes: the C&L Inventory. As to criterion 3, it is still not yet fully regulated and, hence, there is currently no specific list of chemicals for these criteria. However, ESRS 1 paragraph 11 states that ‘… when an undertaking concludes that an impact, risk or opportunity is not covered or not covered with sufficient granularity by an ESRS but is material due to its specific facts and circumstances, it shall provide additional entity-specific disclosures to enable users to understand the undertaking’s sustainability-related impacts, risks or opportunities.’ Additionally, existing standard product specification from CEN/CENELEC, academic literature or other sources could provide valuable guidance to assess the risks of use of certain substances in products that may potentially fall within criterion 3; nonetheless, no list can be provided at this stage.