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safety & regulatory issues
Regulation 1935/2004 is the basis of European
Union legislation, and applies to all package materials
for food contact and defines four basic requirements for
these materials:
1. Shall not endanger human health.
2. Shall not bring about an unacceptable change in the
composition of the food.
3. Shall not alter the taste, smell or texture of the food.
4. Shall be manufactured in accordance with good
manufacturing practices.
The basic principles for Good Manufacturing
Practices (GMP) are detailed in Regulation (EC) No
2023/2006 and were enforced on 1 August 2008.
GMP should be applied to all stages of production of
packages and materials. It excludes production stages
of the starting substances and raw materials. For
example, for the production of a plastic material, GMP
requirements apply to transformers and converters,
including the printing process of the package up to the
production of the final article (SCHAFER, 2010).
Regulation 1935/2004 establishes labeling and
a traceability system requirement for the material or
package, as well as compliance declaration requirement.
This statement should contain all product information
necessary for the food industry to use packages
according to the conditions set out. Each manufacturer
must issue a declaration of compliance for the process
under their responsibility.
Regulation 1935/2004 sets out specific
requirements for the authorization of substances for
food contact (including the Positive List) and migration
limits. The migration tests to verify compliance with
the law follow the methods validated by the European
Committee for
Standardization (CEN).
This regulation contains a list of materials for
which specific legislation should be adopted. This list
contains 17 different materials although specific laws
have been drawn up for only some of them:
• Plastics: Regulation No. 10/2011, Regulation
1282/2011, Regulation 1183/2012.
• Restricting the use of bisphenol A in baby bottles:
Regulation 321/2011.
• Import Procedures for polyamide and melamine
kitchenware from China and Hong Kong - Regulation
284/2011.
• Active and Intelligent Packaging: Regulation
450/2008.
• Recycled plastic materials for food contact:
Regulation 282/2008.
• Regenerated cellulose materials: Directive 2007/42/EC.
• Ceramics: Directive 84/500/EEC.
For materials for which the laws were not
harmonized within the EU, national laws can be applied
as well as the resolutions of the Council of Europe.
European Union
The Center for Food Safety and Applied Nutrition
(CFSAN) of the FDA is responsible for food contact materials.
Substances which have contact with food are
defined by the Federal Food, Drug and Cosmetic Act
(FDCA) as those intentionally used as a component of food
packaging material and which in use has no technical
effect on the food. If these substances migrate into food,
they are considered a food additive and therefore should
be subject to regulations for food additives (Food Additive
Petition - FAP) or be allowed through Food Contact
Notification (FCN). The regulations for food additives
relevant to substances with food contact are found in
Title 21 of the Code of Federal Regulation (CFR) in Parts
174-186 and are related to cellulosic materials, plastics,
adhesives and coatings, manufacturing additives etc.,
while the FCN are listed on the FDA website. Substances
United States of America