On January 23, 2024, the European Chemicals Agency (ECHA) added five chemicals to its Candidate List of substances of very high concern (SVHCs) and expanded the listing of dibutyl phthalate.
According to the Food Packaging Forum’s Database on migrating and extractable food contact chemicals (FCCmigex), four of the five new substances, as well as dibutyl phthalate, have been detected in migration or extraction experiments of food contact articles. Two have been listed for intentional use in food contact applications according to FPF’s Food Contact Chemicals Database (FCCdb). The five FCCs along with the FPF database they are found in are:
- 2,4,6-tri-tert-butylphenol (CAS 732-26-3); FCCmigex + FCCdb
- 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol (UV-329, CAS 3147-75-9); FCCmigex + FCCdb
- 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one (CAS 119344-86-4); FCCmigex + FCCdb
- Bumetrizole (CAS 3896-11-5); FCCmigex
- Dibutyl phthalate, (updated entry, CAS 84-74-2); FCCmigex + FCCdb
FPF submitted comments to ECHA after the announcement that the chemicals were being considered for the Candidate List (FPF reported). In the comments, FPF highlighted that two of the new Candidates are included in Annex 1 of the EU Regulation on food contact materials ((EU) No 10/2011) – the positive list for authorized chemicals in plastic food contact materials (FCMs). REACH ((EU) 2020/2096) demands the substitution of SVHCs by safer alternatives in industrial products, processes, and in consumer articles solely based on their intrinsic hazard properties, not based on their risk (where both hazard properties and exposure levels are considered). However, the human health effects of FCMs are excluded from the REACH authorization process. This means that if a substance becomes an SVHC under REACH this substance’s authorization under Annex 1 is not immediately affected and consequently, known SVHCs can still be used legally in FCMs.
All EU producers of these chemicals or suppliers of products containing chemicals on the SVHC candidate list above a concentration of 0.1% by weight must provide safety information to consumers for safe use of the chemicals and/or products. Companies are also required to notify ECHA under REACH and under the Waste Framework Directive for inclusion in the SCIP database (FPF reported). There are currently 240 chemicals on ECHA’s Candidate List.
Reference
ECHA (January 23, 2024). “ECHA adds five hazardous chemicals to the Candidate List.”
