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The EU Food-Contact DoC and Information Flow in the Adhesives Supply Chain

May 7, 2019

The EU Food-Contact Declaration of Compliance and the Flow of Information in the Adhesives Supply Chain – Overview of the Legal Regime and Some Practical Tips.

Given the complexity of the supply chain for food-contact adhesives and the materials on which they are applied, it can sometimes be a struggle for business operators to determine their precise responsibilities. Clearly, cooperation between each party in the supply chain is essential to ensure that, ultimately, the final food-contact material or article that is placed on the market in the European Union (EU) complies with the applicable food-contact legislation.

I. Brief Overview of how Food-Contact Adhesives are regulated in the EU

To understand what information should be included in a food-contact Declaration of Compliance (DoC), it is important, as a starting point, to be aware of how food-contact adhesives are regulated in the EU.  In brief, adhesives are not specifically regulated at the EU level. Hence, they must simply comply with the relevant requirements of the EU’s Framework Regulation (EC) No. 1935/2004[1] and be manufactured in accordance with Regulation (EC) No. 2023/2006 on good manufacturing practice.[2] Thereafter, adhesives or raw materials used to make adhesives, may be placed on the market in the EU subject to the mutual recognition principle, and taking into consideration any prior-authorization procedures that apply. While certain other harmonized material specific legislation does not directly regulate adhesives, it does, indirectly, set requirements for adhesives. For example, if an adhesive is applied in a multi-layer plastic material, the final plastic material or article must comply with the specific migration limits (‘SMLs’) set out in the Plastics Regulation (EU) No. 10/2011, regardless of whether the substances subject to SMLs are present in the adhesive, the plastic or both.[3]

II. Applicability of DoC requirement to Adhesives

It is also worth noting that while a DoC is not required for adhesives or raw materials used to manufacture adhesives under harmonized EU legislation, Member States may adopt national legislation requiring DoCs for all non-harmonized food-contact materials, including adhesives, placed on their national market and many of them have done so (e.g., France, Belgium, Italy, Denmark, Finland and the Czech Republic).[4] Further, many other Member States such as the United Kingdom recommend that a DoC be provided as part of good business practice.

III. What information should be included in a DoC for Food-Contact Adhesives?

The European Commission’s Guidance document entitled “Union Guidance on Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food as regards to information in the supply chain” dated 11 November 2013[5] (‘The Guidance document on the DoC’) states that the DoC has two main aims:

  • It confirms to the customer the compliance of the product with the Framework Regulation (EC) No. 1935/2004 and any other relevant requirements; and
  • It provides the customer with adequate information necessary to establish or check the compliance of his own product with relevant legislation.

The Plastics Regulation is the harmonized measure that sets out the most detailed information regarding the information that should be included in a DoC. Although this Regulation specifically regulates food-contact plastic materials and articles, it may be used as a reference for other types of food contact materials by Member State enforcement authorities and business operators alike. Annex IV of the Plastics Regulation outlines that the following information must be included in the food-contact DoC for food-contact plastic materials and articles:

  • Identity and address of business operator issuing the DoC;
  • Identity of material or article;
  • Date of declaration;
  • Confirmation of compliance with relevant requirements of the Framework Regulation;
  • Adequate information regarding substances used or their degradation products subject to specific restrictions/specifications;
  • Adequate information regarding dual use additives, which are subject to a restriction in food;
  • Specifications regarding use of material (e.g., types of food that it may be used in contact with, times and temperatures covered, the highest food contact surface area to volume of food ratio covered by DoC or equivalent information); and
  • Conformity of functional barrier with applicable requirements (if used).
     

The Guidance document on the DoC recommends that compliance work be conducted as high up the supply chain as possible and details what the Commission considers to be adequate information to pass down the supply chain for substances used in the manufacture of adhesives and for the adhesives themselves.  Again, the type of information that the Commission recommends business operators in the adhesives industry should pass down the supply chain is heavily modelled on the requirements for plastic materials and articles. In practical terms, it is not possible to set out one definitive check list of responsibilities that can be used by any operator in the supply chain in this article given that these depend on the role and position in the supply chain of the business operator (e.g., manufacturer, importer, distributor) and the type of product that the business operator supplies to its direct customer, i.e., raw material (e.g., monomer or additive used to manufacture adhesive), intermediate non-plastic material (e.g., adhesive) or final article (e.g., final plastic article bound together with adhesives).

IV. Some Practical Tips

One of the conflicts that business operators are faced with is the need to protect trade secret information versus the need to pass adequate information down the supply chain to their customers regarding their product. However, this can be addressed in different ways. For example,

  • If a substance cannot be named in a DoC for confidentiality reasons, and if it cannot be confirmed that the applicable limits are met for all applications, the DoC should include a statement that there are substances subject to restrictions

AND

  • State that they can be disclosed under a confidentiality/non-disclosure agreement

OR

  • State that the details of confidential substances can be requested by a third party (usually a law firm or a laboratory) under a confidentiality agreement. The third party could then verify/confirm compliance and provide its non-confidential conclusions to the business operator purchasing the material.

There are, of course, other approaches that could be taken, particularly, if the business operator is able to determine that the potential specific migration of a substance would be well below the SML, but, again, these would need to be considered on a case by case basis.

When preparing and reviewing a DoC it is important to keep in mind that:

  • General disclaimers may not invalidate the statements of compliance made in the DoC
  • Compliance work should be done as high up the supply chain as possible according to the European Commission
  • Delegation of compliance work is possible but must be specific and must provide the customer with information to take over that compliance work,
    •   E.g., migration of substances X,Y, Z must be checked.
  • DoCs should be clear and detailed and highlight any restrictions to downstream users (e.g. surface area to volume of food ratio used for food-contact evaluation, time or temperature restrictions)
  • Liability is shared throughout supply chain and the more information a business operator passes on to customers, the lesser his own liability
  • Compliance with ISO standards or the United States Food and Drug Administration’s Code of Federal Regulations does not automatically lead to the conclusion that a food-contact adhesive complies with the EU food-contact requirements, although, of course, this may be helpful
  • The DoC should be renewed when there are relevant changes in legislation, new scientific data impacting on safety, or when a change in composition of products impacts on compliance with restrictions
  • Supporting documentation must be maintained on file to back up DoCs[6] 
  • Issuance of a DoC results in liability, so it is important that this process is centralized and controlled (e.g., dedicated people should be responsible for the review and issuance of DoCs)
  • It should be indicated whether the mutual recognition principle is being relied upon as the basis for the lawful marketing of adhesives/raw materials intended for the manufacture of adhesives in Member States maintaining national legislation applicable to adhesives (i.e., primarily Spain and Italy, although some other Member States maintain more minor provisions)

[Note that the conditions to be fulfilled to avail of the mutual recognition principle will differ for food contact materials manufactured in the UK if/when the UK exists the EU Customs Union.]

V. Conclusion

In conclusion, while the issuance of DoCs is never a straightforward exercise, with conflicting interests and demands, it is important to take the time to draft a thorough DoC to mitigate liability and ensure that your company is playing its role in ensuring that the final material or article is in compliance with the EU food-contact legislation. An essential element of this exercise is ensuring that your company has obtained adequate information from your supplier to prepare a DoC. 

It also important to keep in mind that it is the EU based importer that is responsible for ensuring that any food contact materials and articles that he imports comply with the EU food-contact legislation as the importer is placing these products on the EU market. Assuming the UK exists the EU Customs Union post-Brexit, the dynamics will change, as if UK based business operators sell food contact materials and articles to companies in EU Member States, the latter will be classified as the EU importers. This may lead to increasing questions and demands with respect to the Declarations of Compliance/customer assurance statements, notably when food-contact adhesives and raw materials intended to manufacture adhesives are being imported directly from the UK into EU Member States that specifically regulate adhesives. Hence, for this reason, it is all the more important for UK business operators to keep up to date and comply with their legal obligations.

 

This article first appeared in the April 2019 edition of the British Adhesives and Sealants Association’s (BASA) newsletter and is reprinted with permission.

 

[1] Regulation (EC) No. 1935/2004 on materials and articles intended to come into contact with food, as amended.

[2] Commission Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food, as amended.

[3] Commission Regulation (EC) No. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food, as amended.

[4] Further to Article 16.2 of the Framework Regulation (EC) No. 1935/2004, Member States may retain or adopt national provisions for DoCs for non-harmonized food contact materials and articles.

[5] This guidance document is available at the following link: https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_legis_pm-guidance_reg-10-2011_sans-boxes_engl.pdf.

[6] See Art. 16.1 of Framework Regulation and Art 7 GMP Regulation.

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