On October 16, 2023, the European Chemicals Agency (ECHA) completed consultations on six substances that Member States have proposed to include on the REACH Candidate List of Substances of Very High Concern (SVHCs). Five of the proposed substances are known to migrate or be extractable from plastic and other food contact materials according to the Food Packaging Forum’s (FPF’s) Database on migrating and extractable food contact chemicals (FCCmigex). Two of them 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).
For substances on the positive list for plastic FCMs restrictions and specifications regarding their use and specific migration limits (SMLs) can apply. Without an SML, they are subject to the overall migration limit of 60 mg/kg food. In contrast, for non-plastic materials, such as paper and board, metals and alloys, silicones, and rubbers, EU-wide, harmonized regulations do not exist. For these materials, manufacturers rely on national regulations, if existent, or perform risk assessments to be shared with the authorities.
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 any chemical that has been authorized under the Plastic Regulation is not affected if a substance becomes an SVHC under REACH. One reason is that substances from the positive list obtain timely unrestricted authorization for their use in plastic FCMs based on a chemical risk assessment, but no regular revisions of authorizations are foreseen that could consider new data and harmonize the FCM legislation with REACH or other European regulations.
Especially in the absence of material-specific regulations, Article 3 of the FCM Framework Regulation ((EC) No 1935/2004) applies: “materials and articles, […], shall be manufactured […] so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could endanger human health.” However, consistency and clarity between regulations could be improved if any SVHC is automatically reassessed and undergoes an authorization process for its application in FCMs – whether or not it has been previously authorized for its use in FCMs.
Since currently SVHCs are not automatically restricted for FCM use in the EU, an alternative approach to better guarantee safety would be the following: Re-evaluation of any risk assessment that provides the basis for authorization of an FCM substance as soon as this substance is classified as an SVHC. Such a re-evaluation should include the most current data on toxicity and actual exposure, but also a socio-economic analysis and search for substitutions as it is demanded under REACH. Combining better enforcement, an explicit ban of SVHCs without specific authorization for use in FCMs, and re-evaluations of previously authorized FCM substances could lead to safer materials in the EU.
The five substances, their reason for potential inclusion on the Candidate List, the FCMs they were measured in or to migrate from, and their inclusion status in the EU FCM regulation:
| Chemical | CAS | proposed reason for SVHC status | FCMs migrated or extracted from | in Annex 1 (plastics positive list) |
|---|---|---|---|---|
| 2,4,6-tri-tert-butylphenol | 732-26-3 | Toxic for reproduction; PBT; vPvB | polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), recycled PET, and polyamide (PA) plastics | No |
| 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol | 3147-75-9 | vPvB | polycarbonate (PC), polyethylene (PE), polypropylene (PP), and undisclosed plastic polymers and printing inks | No |
| 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one | 119344-86-4 | Toxic for reproduction | aluminum, multi-material, paper/board, multilayer plastic, polypropylene (PP), and polystyrene (PS) | No |
| Bumetrizole | 3896-11-5 | vPvB | polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polylactic acid (PLA), and mulitlayer plastics | Yes |
| Dibutyl phthalate | 84-74-2 | Endocrine disrupting properties (environment) | aluminum, steel, multimaterial, cork, rubber, silicone, wood, paper/board, recycled paper/board, multilayer plastic, as well as polyamide (PA), polycarbonate (PC), polyethylene (PE), polyethylene terephthalate (PET), recycled PET, polypropylene (PP), polystyrene (PS), and polyvinyl chloride (PVC) plastics | Yes |
Reference
ECHA (2023). “Proposals to identify Substances of Very High Concern previous consultations.”
Read more
Geueke, B., and Muncke, J. (2018) Substances of Very High Concern in Food Contact Materials: Migration and Regulatory Background. Packag. Technol. Sci., 31: 757–769. https://doi.org/10.1002/pts.2288.
