Our Technical Services Manager, Eric Andrews has been sharing his interpretations of the updates to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food in our ongoing blog series. And, so far, he’s provided insights regarding the chromium species and their handling in this amendment and discussed all things PAA.
These two concepts, plus the additional layer of understanding and recommendations/requirements for metals beyond chromium come together in the restructuring of Annex II.
Before this amendment, Annex II – Restrictions on plastic materials and articles – was an important but scant section.
Up to this point, it’s always placed restrictions on the release of metals (eight elements with associated migration limits) into materials and articles coming into contact with food, as well as a blurb about PAA as an entire category of impurities.
Annex II has received a much-needed and complete overhaul to the point it served in the first place: to unpack and analyze the risk in the consumption of specific metals and specific PAA AND these substances as entire categories in total.
This section begins with organizing the list of metals with set restrictions into a table format with information extending to 24 elements – as well as their salts.
Specific Migration Limits (SMLs) are still in place, but a “Remarks” column and corresponding legend have been added and are consistent with the format of the rest of the EU/EC regulatory guidance documents.
Another noteworthy change, which is mentioned elsewhere in the amendment is the inclusion of lanthanide metals and metal-salts – a category of species not previously fleshed out.
In this installment of our series, Eric will share his interpretation of Annex II.
The bold content signifies the regulation while the red italicised copy is Eric’s interpretation.
(3) The Authority adopted a favourable scientific opinion (3) on the use of isostructural salt complexes of terephthalic acid (generically described as 1,4-benzene dicarboxylic acid, FCM substance No 785) with the following lanthanides: lanthanum (La), europium (Eu), gadolinium (Gd) and terbium (Tb) used alone or in combination and in varying proportions, as additives in plastics intended to come into contact with foods. For a building block of PET, terephthalic acid, the formation of salts with the aforementioned lanthanides do not pose a risk greater than that of other metals or metal-salts for use in said polymer types. The Authority concluded that those salts are not of a safety concern for the consumer if used as additives in polyethylene, polypropylene or polybutene plastic materials and articles intended to come into contact with all food types under contact conditions of up to 4 hours at 100 °C or for long-term storage at ambient temperature. This conclusion is made on the basis that, if migration from the plastic food contact material to the food or food simulant were to occur, the lanthanides should be present in the food or the food simulant in dissociated ionic form (This is typically seen as a benefit in terms of metabolizing and/or passing species from the body and has roots in toxicological approaches to gauging hazards like mutagenicity and genotoxic carcinogenicity) and the migration of the sum of the four lanthanide ions (La, Eu, Gd, Tb) when used alone or in combination should not exceed 0,05 mg/kg food. This SML falls in a range commensurate with other species of concern from an inherent hazard standpoint.
(2) Annex II is replaced in its entirety by the following:
‘ANNEX II Restrictions on plastic materials and articles the following restrictions on plastic materials and articles apply:
Substances listed in Table 1 shall only be used in accordance with the compositional requirements set out in Chapter II. If Chapter II does not provide a basis for the authorised use of such a substance, that substance may only be present as an impurity subject to the restrictions specified in Table 1.
(1) The migration is subject to Article 11(3) and Article 12
(2) The note in Annex I, Table 1, FCM No 398 applies: SML might be exceeded at very high temperature
(3) To verify compliance with the Regulation, the detection limit of 0,01 mg/kg shall apply for total chromium. However if the operator that placed the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material is excluded because it is not used or formed or during the entire production process, a limit for the total chromium of 3,6 mg/kg food shall apply.
(4) The lanthanide substances europium, gadolinium, lanthanum, and/or terbium can be used in accordance with Article 6(3)(a) provided that:
(a) The sum of all lanthanide substances migrating to the food or food simulant does not exceed the specific migration limit of 0,05 mg/kg; and
(b) analytical evidence using a well described methodology demonstrating that the lanthanide substance(s) used are present in dissociated ionic form in the food or the food simulant, forms part of the documentation referred to in Article 16.
Conclusions to be drawn from this installment include: Annex II feeds directly into issuing one’s declaration of compliance. The EU is already commendable in their traceability requirements from all business operators throughout the FCM marketplace – this fleshed out addition of Annex II only bolsters that connotation further. The addition of a wide array of transition, alkali earth and lanthanide metals to the annex is sign of the times and reflects the development and use of novel additives to improve the performance of plastics and the economy of manufacturing them efficiently.
Keep an eye out for our next installment when Eric will discuss Annex IV and the reforms to the declaration of compliance.
In the meantime, if you’re interested in learning more about how our team at CSS can help manage these changes for your business, contact Kelly Schaefer.