- May 31, 2005, Sheila A. Millar Attorney-at-Law, Keller & Heckman, Washington, DC
Packaging products, particularly products in contact with food, are subject to regulation around the world. The differences in those regulations, particularly differences between the US and European Union (EU) systems, reflect fundamental differences in policy, rooted in their respective legal frameworks, that are important for industry members to understand. The subject is highly technical and complex; we provide here only a brief overview.
Under Section 201 of the Federal Food, Drug and Cosmetic Act (FDCA), food additives are defined as follows: …any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in…packing…packaging…or holding food….
Excluded from this definition are substances not reasonably expected to become a component of food ("no migration"), those "generally recognized as safe" (GRAS), and "prior sanctioned" substances.
Substances meeting the "food additive" definition are required by law to be "pre-cleared" by FDA, i.e., the subject of an applicable food additive regulation clearing the specific use, a Threshold of Regulation letter granted in accordance with FDA’s regulations, or an applicable Food Contact Notification (FCN).
Other exemptions apply to housewares, packaging materials separated from food by a functional barrier, or polymerization aids used at low levels to make a duly regulated polymer. The "no migration" principle allows for self-determinations by marketers that their products are not likely to become a component of food and thus are not subject to FDA’s pre-clearance authority. It allows companies to bring products to market quickly, efficiently, and safely, without unduly burdening either FDA or the company.
The FCN process adopted several years ago allows for far better turnaround times for FDA clearance, permitting the substance to be marketed 120 days after submittal unless FDA objects. Unlike Food Additive Regulations, which are generally applicable to any company that can meet the terms and conditions of the regulation (including, but not limited to, the petitioner), FCNs are proprietary to the notifier and his or her customers.
Regulatory activity governing food contact materials in the EU began at the national level. The history of EU-level regulations is linked to changes in the makeup of the European Community (now the EU), and in differences between the legal effect of "Directives" versus "Regulations."
"Directives" must be implemented at the national level. The process takes much time and sometimes involves new twists or requirements at national level that can complicate the process of EU-wide compliance. Regulations, on the other hand, automatically apply in the Member States and do not require further national implementation.
The most significant feature of the European approach to regulating food additives has been reliance on "positive lists" of permitted substances as a basis for marketing of food contact materials.
The Framework Regulation covering materials intended to come into contact with food (Reg. No. 1935/2004) became effective Dec. 4, 2004. By its terms, the Regulation clarifies its intended application to all materials which, in their finished state, are intended to contact food, or can reasonably be expected to contact food, or transfer their constituents to food under normal or foreseeable conditions of use. This includes so-called active and intelligent packaging.
The Commission currently is working on a "Super Regulation" covering food contact plastics materials. The plan is to finalize the Super Regulation in 2006, to be effective in 2007. Also relevant to the converting industry is the European Commission’s proposal for a new EU-wide regulatory framework on chemicals: Regulation, Evaluation and Authorization of Chemicals ("REACH"). In late April, a High Level Group met to evaluate impact assessment information, including the impact on supply chains, provided by members of the chemical, automobile, flexible packaging, inorganics, and electronic sectors. The Group acknowledged the potential impact of REACH on smaller-volume chemicals and SMEs.
The regulatory picture is becoming increasingly complicated for converters and suppliers at a time when expanding into global markets and improving efficiencies are increasingly important.