The updates to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food have been released and our team at Colour Synthesis Solutions is ready to address and handle these updates with our state-of-the-art LCMS and GCMS.
But, if you provide food contact plastics and are unsure of how to move forward, you’ll want to pay attention to our next several blogs as our resident expert and Technical Services Manager, Eric Andrews, breaks these updates down topic-by-topic and offers his interpretation of the regulations and how they’ll impact your products moving forward.
In these blog posts, we’ll share the big picture and highlight specific portions of the document. We’ll start by focusing specifically on Primary Aromatic Amines (PAA).
The bold content signifies the regulation while the red italicised copy is Eric’s interpretation.
(24) Primary aromatic amines (‘PAAs’) may be used in plastic food contact materials as colorants or may be present as not intentionally added substances in accordance with Article 6 of the Regulation. PAAs are a large family of compounds, some of which are carcinogens, while others are suspected carcinogens. Certain PAAs may have adverse effects at any migration level, therefore they should not migrate into the food. However, it is not possible to exclude their migration analytically, as analytical methods can only exclude migration above their limit of detection. For the purpose of compliance verification, and to ensure legal certainty, the migration of PAAs into food has been restricted to a specified level that is not detectable in the food or food simulant by means of commonly used analytical methods. The Commission addressed the fact that they originally had required no PAAs migrate to food when using a certain detection technique. However, according to the EURL-FCM advances in analytical capabilities ensure that equipment is now commonly available that allows to lower the detection limit of 0,01 mg/kg food or food simulant that the Regulation presently assigns to the detection of individual PAAs to a new detection limit of 0,002 mg/kg food or food simulant. Therefore that lower detection limit should be defined in the Regulation as the detection limit for individual PAAs. It’s now required that all non-listed PAA be shown not to migrate to food via a validated technique that is capable of LOD <2 ppb per analyte.
(25) At present, the restriction on PAAs in Annex II applies to all PAAs that are not listed in Table 1 of Annex I to the Regulation. These are otherwise known as, “non-listed” PAA (substances). Applying the new low detection limit that this Regulation now assigns would require testing for a large number of substances, and, not all PAAs would adversely affect health above that detection limit. The Commission has always been reasonable about the fact that “NIAS” as a group can quite literally be any species and they’ve recognized that it’s virtually impossible to comment on every tier of possible degradation products migrating to food. The most problematic PAAs are listed in entry 43 of Appendix 8 to Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council(15), ‘the Azocolourants entry’. It is therefore appropriate to apply the new detection limit only to these substances, given their established toxicity. There are still only 22 PAA in this appendix subject to regulation within the EU – Member States continue to add to this list for their own regulatory layer of compliance requirements. Other PAAs for which no limit is laid down in Annex I should be assessed in accordance with Article 19 of the Regulation. However, to avoid their combined toxicity may cause adverse health problems, it is appropriate to limit their total migration to a maximum of 0,01 mg/kg food or food simulant. The overarching requirements laid out in Article 19 remain in effect and are designed to capture all species which may be present at relatively high levels, but for which there are no set SMLs.
(26) Point 2 of Annex II to the Regulation requires that the sum of PAAs does not exceed 0,01 mg/kg food or food simulant, to avoid that their collective presence can cause adverse health effects. As the limit of detection is now lowered to 0,002 mg/kg food or food simulant for all PAAs listed in the Azocolourants entry, the sum would not require evaluation if such a PAA is detected because the material would not be in compliance with the Regulation anyway in this case. This is meant to reiterate the first point above – that any of the targeted PAA cannot be present at all when using a detection technique with updated sensitivity, otherwise it’s outside of the scope of compliance. This will hold business operators to a higher standard of raw materials and quality control to ensure this strict requirement is met. However, when it is known or suspected that certain PAAs not listed in Annex I or in the Azocolourants entry may be present, their presence can be assessed on the basis of migration testing and modelling considerations. Therefore, it is appropriate to maintain the provision that the sum of those PAAs does not exceed 0,01 mg/kg food or food simulant. The Commission explains why the sum limit is still required, which maintains a two-point check to account for listed, targeted non-listed, and unknown-non-listed NIAS.
(14)EFSA Journal 2012;10(12):2985. (15)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). ENOfficial Journal of the European Union 3.9.2020 L 288/7