In this installment, Eric will focus on Annex IV and the “Declaration of Compliance.”
What stands out the most about this Annex of food contact compliance is there isn’t an officially mandated equivalent by authorities in the United States.
The culture and requirement of the passing of pertinent and typically critical information from business owners downstream in all things food-contact is a policy that minimizes repeat work like that of impurities testing, as well as directly fostering the information of businesses and consumers to the safety of the products they’re trading.
Annex IV explains the requirements of the Declaration of Compliance (DOC) document and establishes its uniformity. Below, the bolded text are excerpts from the 10/2011 and the red, italicised text are comments and amendments originating from the latest update.
(27) The new or updated restrictions on substances in Annex II require clear communication in the supply chain to ensure that adequate information on the presence of these substances is available to business operators which use products from intermediate stages in the supply chain or final articles or materials in which these substances may be contained. When such information is not provided they cannot be certain on the presence and amount of these substances and they would need to test more frequently than would be needed if that information was provided. This is all very simple, logical, and incredibly useful. The EU regulations often mention that the motivation for such great traceability is for the benefit of the business operators obligated to adhere to it. With such transparency a requirement, the economy as a whole need only perform certain testing when absolutely necessary – always of course with the public safety interest in mind. This mitigates unnecessary/repeat testing under an equivalent authority wherein such a feature of regulation is not present. However, if the presence and amount of these substances is known to these business operators, in many cases simple calculation techniques can suffice to establish whether a limit could be exceeded, and analytical testing would not be required at all. Moreover, communication of the amounts of substances is also required to communicate on the presence of these substances to later stages of the supply chain. Therefore, it is appropriate to amend point 6 of Annex IV to the Regulation to clarify that the amount of substances subject to limits under Annex II should be included in the declaration of compliance. This is the foundation for the amendment in the Annex as can be seen below.
(28) Before placing an intermediate or final product on the market, the manufacturer of that product needs to assess whether it complies with Article 3 of Regulation (EC) No 1935/2004, and/or complies with Article 19 of the Regulation. Various and complementary approaches should be used in such assessment. A common and cost efficient testing approach is to determine only the safety of substances that are present above a concentration of 10 ppb by using migration testing with a food simulant. Substances that do not exceed this limit are then considered safe. However, the migration of substances at a level of 10 ppb can only be considered safe provided that their genotoxicity can be ruled out. Therefore, the use of such a testing technique should always be complemented by an assessment of whether substances that could be genotoxic are present. Therefore, it should be communicated to downstream users of an intermediate or final material that it may contain substances of which the genotoxicity has not been ruled out. This is the crux of the Annex in as few words as possible. It is insufficient only to profile the final product. The obligation to check and rule out toxicity of the degradation and side products falls to the business operator that has done anything to change the substance received from upstream. Then, this information is handed off to the next business where another check is performed and so on until it reaches retail in as safe a way as possible. Producers of intermediate materials know that these substances can be present in their products as they use preparations that contain them, or should obtain that information from their suppliers. Therefore, point 6 of Annex IV should also be clarified to require information on substances present in a material or article, of which genotoxicity has not been ruled out.
Declaration of Compliance
The written declaration referred to in Article 15 shall contain the following information:
(1) the identity and address of the business operator issuing the declaration of compliance;
(2) the identity and address of the business operator which manufactures or imports the plastic materials or articles or products from intermediate stages of their manufacturing or the substances intended for the manufacturing of those materials and articles;
(3) the identity of the materials, the articles, products from intermediate stages of manufacture or the substances intended for the manufacturing of those materials and articles;
(4) the date of the declaration;
(5) confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet relevant requirements laid down in this Regulation and Regulation (EC) No 1935/2004;
(6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions; This segment of the Annex is elaborated on in the revision, which can be seen below. Often considered the most ambiguous point in the requirement of the production of a uniform DOC document – this is now fleshed out in a way that creates better traceability.
(7) adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food;
(8) specifications on the use of the material or article, such as:
(i) type or types of food with which it is intended to be put in contact;
(ii) time and temperature of treatment and storage in contact with the food;
(iii) ratio of food contact surface area to volume used to establish the compliance of the material or article;
(9) when a functional barrier is used in a multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation.
(3) in Annex IV, point 6 is replaced by the following:
‘(6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.
At intermediate stages, this information shall include the identification and amount of substances in the intermediate material,
— that are subject to restrictions in Annex II, or
— for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to a migration from the final material exceeding 0,00015 mg/kg food or food simulant.’; This pays special attention to the toxicological concern of degradation products of the target, which are often more reactive than the target product itself. Emphasis has always been placed on the degradation and side products that were to have undergone analysis for just this reason. But, with the update, a real and meaningful number has been assigned to the limit to which these materials are allowed. Simply having a hard number instigates the requirement for business operators to test and pass along that critical safety information downstream to the consumer.
In our next and final installment of the updates to EU No. 10/2011, we’ll interpret the revisions to Annex V which has to do specifically with migration testing and repeat-use products.
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.