Belgium, the Netherlands Pursue Rules on Food-Contact Coatings
The food-contact coatings sector is about to face significant legislative changes in the European Union (EU). These include the ongoing amendment to long-standing Dutch legislation, as well as new draft Belgian legislation that is proposing to regulate food-contact coatings for the first time.
Food-contact coatings are not specifically regulated at EU level. Hence, the general requirements of the Framework Regulation (EC) No1935/2004 and the Good Manufacturing Practice Regulation (EC) No 2023/2006 apply. (There are also other EU measures that may impact on coatings, but they do not constitute specific measures.) However, many Member States already maintain national requirements for food-contact coatings, for example, the Netherlands, Spain, Italy, Greece, the Czech Republic and Slovakia. Of these, the Dutch coatings legislation is probably the most extensive.
Spain has recently updated its coatings legislation with the enactment of Royal Decree 847/2011. This legislation incorporates many of the concepts set out in the Plastics Regulation, such as the dual-use additives declaration requirement, the application of the generic specific migration limit (60 mg/kg) to substances in its positive list that are not subject to specific restrictions, and most importantly, the adoption of test conditions set out in the Plastics Regulation. The draft Belgian and Dutch texts also follow this approach.
In the Netherlands, the (amended) Warenwet (law) of December 28, 1935, is the framework legislation setting out the general provisions applicable to food-contact materials. The Packaging and Utensils Regulations of 1979 (as amended) set out the requirements applicable to food-contact materials and articles, notably, the "positive lists" of substances that are permitted for use in their manufacture. Coatings are specifically regulated in Chapter X, Appendix A, of these regulations, which are being revised significantly.
In Belgium, the overarching legislation regulating food-contact materials and articles, which is currently also undergoing revision, is the Royal Order of May 11, 1992. This law also sets specific requirements for certain food-contact materials, but not for coatings, so the adoption of the draft coatings legislation will change the country's regulatory landscape drastically.
What food-contact materials will be regulated?
Like the current Chapter X, the draft Dutch legislation will maintain a broad scope by regulating a wide range of coatings intended to come into contact with food. The draft is divided into four sections: generic coatings (coatings that may be applied on all substrates); metallic coatings; wax coatings; and high temperature coatings. In contrast, the scope of the draft Belgian Order is limited to metal packaging, flexible packaging, and heavy-duty coatings.
Positive lists in the Netherlands v. indicative list in Belgium
One of the fundamental ways in which the Dutch draft differs from the Belgian one is that the lists set out in Chapter X will continue to be positive lists, whereas the anticipated Belgian list of substances authorized for use in coatings, will be merely "indicative."
The main section in the Dutch draft is "generic coatings." This section is divided into expanded positive lists for monomers on the one hand, and for additives, polymer production aids, and aids to polymerization on the other. Additionally, the draft Chapter X will authorize monomers/starting substances and additives listed in Annex I of the Plastics Regulation to be used in the manufacture of food-contact coatings, provided that applicable restrictions or specifications set out in the Regulation are met. This is significant, as no such cross-reference to the Plastics Regulation exists in the current version of Chapter X.
Appendix A of the 1979 Dutch regulations is also being revised to include a new and very important Chapter 0, which will include general provisions mostly applicable to all food-contact materials and articles regulated in the Netherlands. Chapter 0 outlines that, for non-plastic materials such as coatings, unlisted substances may be used provided that they:
- Are not carcinogenic, mutagenic or toxic to reproduction (CMRs);
- Migrate at less than 10 ppb; and
- Are not substances in nanoform.
An unlisted substance does not have to be separated from the food by a functional barrier to migration, as required under the Plastics Regulation.
In contrast, the Belgian "indicative list" will not be included in the legislation itself, but, instead, will be published on the website of the Belgian Federal Public Service (SPF) Public Health, Food Chain Safety and Environment. This was done to ease updating, and to avoid the need to comply with a burdensome legislative process. In accordance with the draft Belgian Order, monomers/starting substances and additives would be authorized in the manufacture of coatings subject to its scope, if they:
- Are listed in the Plastics Regulation; or
- Are officially authorized in the national legislation of another EU Member State; and
- Have been evaluated by a competent authority, provided that the toxicological evaluation meets the European Food Safety Authority's criteria – this could apply to evaluations conducted by the U.S. Food and Drug Administration, for instance.
Of course, applicable restrictions and/or specifications would have to be met in all cases.
Furthermore, the draft Belgian Order outlines that substances not meeting these criteria may still be used in food-contact coatings if:
- They comply with Article 3 of the EU's Framework Regulation (i.e., they do not endanger human health or bring about an unacceptable change in the composition of the food, or a deterioration in the organoleptic characteristics of the food);
- They do not migrate at a level greater than 10 ppb;
- They are not CMRs; and
- The declaration of compliance asserts reliance on the no migration principle. Like the Dutch draft, there is no requirement that such substances must be used behind a functional barrier but, in contrast, the proposed Belgian Order does not exclude substances in nanoform from the above exemption.
Importantly, there is no requirement in either of the draft texts that substances in nanoform be explicitly listed as such (in contrast to the Plastics Regulation).
Declaration of Compliance and supporting documentation
Both draft texts propose to introduce a declaration of compliance requirement for food-contact coatings falling within their scope, pursuant to Article 16(2) of the EU Framework Regulation, as amended. The draft Belgian Order goes one step further as it defines the content of the declaration of compliance.
The Dutch draft proposes to introduce a requirement that "relevant" information be passed along the supply chain in relation to dual-use additives (additives used in the manufacture of a coating that are also authorized food additives), in the same way as the Plastics Regulation. That said, the Dutch draft sets a specific migration threshold for dual-use additives from the coating, above which information must be passed on. The proposed threshold is 5% of the limit set out in the food additives legislation.
Similarly, the Belgian draft includes a provision that adequate information be passed along the supply chain on dual-use additives. However, unlike the Dutch version, it does not propose to introduce a specific migration threshold, but leaves this to the discretion of business operators.
Generic SML of 60 mg/kg
Like the Plastics Regulation, both the Dutch and Belgian drafts propose to introduce a generic specific migration limit of 60 mg/kg, which will apply to all substances authorized for use in coatings that are not subject to a specific restriction.
Safety Assessment of Non-Intentionally Added Substances (NIAS)
An explicit requirement that a safety assessment must be conducted on non-intentionally added substances (NIASs) is another proposal included in the Dutch legislation. Although there is no such clause in the Belgian Order, such an assessment would be needed to certify compliance with the safety requirement in Article 3(1)(a) of the EU Framework Regulation.
The Dutch are also proposing to replace the test conditions in its existing legislation with those in the Plastics Regulation. Similarly, the draft Belgian Order incorporates the migration test conditions set out in the Plastics Regulation, with some minor deviations. For example, citric acid at 5 mg/l may be used as an alternative simulant to simulant B (3% acetic acid) for coatings on metal substrates. In both jurisdictions, the overall migration limit, as set out in the Plastics Regulation, of 10 mg/dm2 (or 60 mg/kg for coatings intended for infants and young children) will apply.
Mutual Recognition clause in draft Belgian Order
The draft Belgian Order states that its provisions, with the exception of Article 8 (the declaration of compliance requirement), shall not apply to products legally manufactured and/or marketed in other EU Member States, the European Economic Area or Turkey. The Dutch draft does not contain such a mutual recognition clause. However, given that this is a general principle of EU law, it applies even though no such clause is included (although there are some limitations/exceptions to this principle).
The path to adoption
With respect to the Dutch draft, Chapter 0 and the updated testing conditions were notified to the European Commission on July 23, further to Directive 98/34/EC on the procedure for providing information for technical standards and regulations. The end of the standstill period, during which the Commission and Member States may comment on the draft text, ends on October 23. However, it is possible that this period may be extended by a further three months, if the Commission or a Member State submits a detailed opinion that the draft text hinders the free movement of goods in the EU. During the standstill period, the Netherlands may not take any steps to adopt the draft text. It is expected that the updated Chapter X (coatings) will be notified to the Commission in 2014. It is noteworthy that the draft Chapters 0 and X do not contain transitional provisions, which could cause serious difficulties to industry if they were adopted as they are currently worded.
The draft Belgian Order has not yet been notified to the European Commission. It contains a transitional provision, the language of which is under discussion. Also the timeline for entry into force of the draft Belgian Order, set for December 31, is likely to be affected by the time needed to complete the notification process.
While both drafts propose significant new requirements, the Dutch text would appear to impose the more severe obligations on business operators in view of its broad scope and the detailed requirements set out in Chapter 0. The absence of a mutual recognition clause in the draft Dutch text may also present challenges to operators in the coatings industry that import into the Netherlands, as it may signify that the Dutch authorities, by contrast to Belgian authorities, are reluctant to implement the mutual recognition principle in practice (although, as previously noted, it is a general principle of EU law and would apply, even if not explicitly included in the adopted text). Yet, Member States may only deny mutual recognition when certain conditions are met. Further, the absence of this clause may lead to a lack of awareness amongst business operators that they may potentially have recourse to the mutual recognition principle when importing products that were already lawfully manufactured or marketed in another EU Member State into the Netherlands.
A version of this article first appeared in ChemicalWatch: Global Risk & Regulation News. It is reprinted with the permission of ChemicalWatch.