European Commission Publishes the 4th Amendment to the Plastics Directive

On March 30, 2007, the European Commission published the 4th Amendment to the Plastics Directive (Directive 2007/19/EC). The corrigenda to Directive 2007/19/EC, published April 2, 2007, in the Official Journal of the European Union, provides the final version of the 4th Amendment. The Plastics Directive 2002/72/EC was originally published in August 2002 (for an overview of the Plastics Directive and a brief history of EU food contact legislation, see related articles below). This article is intended to highlight and summarize some of the key changes to the Plastics Directive as a result of the adoption of the 4th amendment.

Key Changes

The most significant changes introduced by the 4th Amendment include:

• The functional barrier doctrine for plastics
• Revisions to the overall migration limit
• Epoxidised soybean oil (ESBO) and other plasticizers in gaskets
• Gaskets and new plastizers permitted in gaskets
• New food simulant for milk
• Fat reduction factor
• Declaration of compliance

A more detailed review of each of these changes follows below.

Functional Barriers

The functional barrier doctrine for plastics permits layers in multi-layer plastic articles to contain substances that are not included on the Plastics Directive or national lists of authorized components and exempts those layers from compliance with existing restrictions on listed substances, provided that the layers are separated from food by one or more layers that would prevent migration of any unlisted or out-of-compliance substances into food at a level exceeding 0.01 mg/kg (10 ppb). The functional barrier exemption is only applicable to substances that are not carcinogenic, mutagenic, or toxic to reproduction.

OML Revisions

The 4th Amendment revises Article 2 of the Plastic Directive to establish an overall migration limit for plastic material and articles to foodstuffs of 60 milligrams per kilogram (mg/kg) of food. In certain cases, though, 10 milligrams per square decimeter (mg/dm2) of surface area is permitted (e.g. in the case of sheet, film or other material or articles which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of such material or article and the quantity of food in contact therewith). However, when the plastics material is intended to be brought into contact with food for infants and young children, the overall migration limit must always be 60 mg/kg.

ESBO Limitations and New Plasticizers for Gaskets

Due to concerns about exposure of adults to epoxidised soybean oil (ESBO), the 4th Amendment sets a shorter deadline (July 1, 2008) for the compliance of gaskets in lids with the restrictions of ESBO and a number of other listed plasticizers set forth in Annex III of the Plastics Directive as amended. The 4th Amendment specifies that gaskets, even it they are part of metal lids, fall under the scope of the Plastics Directive. To allow manufacturers sufficient time to prepare an application for the evaluation of specific additives, the positive list of authorized additives that will be adopted for plastic materials in the future will not apply to the manufacture of gaskets in lids. This will allow other additives to be used for the foreseeable future in the manufacture of gaskets that are in compliance with the national laws of the EU Member States.

Milk and Fatty Food Reduction Factors

The 4th Amendment revises the migration testing Directive (Directive 85/572/EEC), by replacing distilled water with 50 percent ethanol for some milk products, to better simulate their fatty character.

"Fat Consumption Factors" (FRF) allow the use of reduction factors, in addition to the existing Simulant D reduction factors permitted under Directive 85/572/EC, when verifying compliance with specific migration limits for lipophilic substances contacting fatty foods. A list of lipophilic substances currently permitted under the Plastics Directive, and for which these FRF could be used, will be added in a new Annex to the Practical Guide. Correction by the FRF is not allowed under several conditions, including when the material or article is intended to be brought in contact with food intended for infants and young children, as defined by Directives 91/321/EEC and 96/5/EC.

Proving Compliance

The 4th Amendment also introduces a new aspect to Article 9 regarding "recordkeeping." Specifically, documentation will be necessary to suitably demonstrate compliance with the Directive and such documentation must be kept available for public authorities on demand. At each stage of manufacture, supporting documentation substantiating a declaration of compliance is required. The 4th Amendment also states that food business operators should be given access to "the relevant information to enable them to ensure that the migration from the materials and articles to food complies with the specifications and restrictions laid down in food legislation."

Effective Date

Since the 4th Amendment is a Directive, it is not immediately effective in the EU but rather it must be implemented into national law by each of the Member States. Article 3 of the 4th Amendment sets May 1, 2008 as the deadline for Member States to adopt and publish laws, regulations and administrative provisions necessary to comply with the 4th Amendment. In practice, a company selling a product in accord with the 4th Amendment is not subject to adverse action by a Member State pending adoption of the amendment by the Member State as the listing reflects the Commission's position that the material is safe for the intended applications.