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How EU Flexible Packaging Regulations Affect North America

Posted 10 Apr 2019 by Justine Hanlon, Senior Account Manager, Tapes, Labels, and Graphics

European Union (EU) regulatory compliance is complicated and requires a working knowledge of multiple regulation statutes and legislation to understand. A general knowledge of REACH and EU Framework Regulation (EC) No 1935/2004 and No 10/2011 is a great place to start for understanding EU compliance for flexible packaging. Many North America converters are growing more concerned about EU regulatory compliance and want to be able to reassure food companies and brand owners that a package produced in North America will be compliant with country-specific regulations as well as the EU framework.

The EU’s definition of food contact materials is very broad. It includes both food packaging materials and any other materials and articles that are expected to come into contact with food under normal end-use conditions. Chemical companies, including adhesive companies that supply food contact materials and packaging, and food companies need to comply with the EU’s food contact regulation. Adhesives typically make up less than 5 percent of the total weight of packaging and direct food contact is not intended for most applications. Click here to learn more about food safe packaging.

REACH

REACH is an EU regulation concerning the Registration, Evaluation, Authorization and restriction of Chemicals. It kicked off in June 2007 and replaced a number of European Directives and Regulations with a single system. REACH applies to substances manufactured or imported into the EU in quantities of one ton or more per year. It largely applies to all individual chemical substances (i.e. CAS#s) on their own, in mixtures or in articles, and allows only registered substance to be placed on the market in the EU for the person who has filed the Registration.

The registration process allows manufacturers and importers of substances (i.e. CAS#s) in the EU to produce data on the substances they manufacture or import, use the data to measure risk, and develop risk management plans measures to address the potential risks of the substances.

EU Framework Regulation No 1935/2004 & No 10/2011

Regulation (EC) No 1935/2004 provides a harmonized legal EU framework. The requirement is that materials do not release their components into food at levels that are harmful to human health and do not change food composition, taste and odor in an unacceptable way. This regulation provides, among other requirements, a list of authorized substances. Evaluations from a national European country list can be used, provided they comply with article three of Regulation (EC) 1935/2004. Table 1 provides national measures regarding adhesives.

Adhesives are not yet treated as an individual regulated group, so the European regulation of adhesives is not harmonized. Adhesives are mentioned in Annex 1 of the framework directive Regulation (EC) 1935/2004 but specific regulation for adhesives has not been published currently. The Regulation (EC) No 10/2011 is a specific measure for plastic food contact materials as mentioned in the European Framework Regulation (EC) 1935/2004 that gives more specifics regarding the use of adhesives in food packaging.

Packages that are printed, coated or held together by adhesives are allowed to contain substances other than those specifically laid out in No 1935/2004. In recent years, plastic food contact materials that consist of up to 15 different plastic layers to attain optimum functionality and protection of the food, while reducing packaging waste, have been developed. In such a plastic multi-layer material or article, layers may be separated from the food by a functional barrier. This barrier prevents the migration of substances from behind that barrier into the food. Behind a functional barrier, non-authorized substances (NIAS) may be used, provided they fulfill certain criteria and their migration remains below a given detection limit.

 

Adhesives and EU Regulation

Adhesives are not yet covered by a specific EU regulation and, therefore, are not subject to the requirement of a declaration of compliance. The best practice for using adhesives in plastic materials and articles is to provide enough information to the food manufacturer to ensure compliance for substances for which migration limits have been established.

Material

Positive List

SML or OML

Substance Quantity in Material (QM)

Adhesives

DE, ES, FR, HR, IT, NL

ES, HR

DE, ES, FR, HR, NL

Table1. National measures for adhesives are available in six main member states (Germany, Spain, France, Croatia, Italy, and the Netherlands). All apply to a list of authorized substances (no negative list). OML and SML and QM ("quantity in material") or residuals are set out for two MSs (Spain, Croatia), whereas only QM-type limits or compositional restrictions are used in Germany, France and the Netherlands.  (Source: Non-harmonized food contact materials in the EU: Regulatory and market situation: BASELINE STUDY: Final report)

For more details on how to select a suitable adhesive for application in food contact materials, please consult the FEICA Guidance for a food contact status declaration for adhesives.

H.B. Fuller has regional and global regulatory specialists who understand complex regulations and can help with migration testing, NIAS studies, declarations of compliance, supplier document assessment, and regulatory clarifications.

If you need help navigating this complex process, or for more information on EU regulatory compliance, send me an email.

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