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Welcome to GPC Europe - Regulation

  • They have 4 specific regulations on FCM based on a positive list of individual substances– 2004, amended from time to time.
  • (Plastics (10/2011/EU), recycled plastics (282/2008/EC) ceramics (Directive 84/500/ EEC), regenerated cellulose (Directive 2007/42/EC) and active/ intelligent packaging materials (450/2009/EC). For these DOC is mandatory.
  • Specific measures on substances are present – i.e. positive list of monomers and additives.

In the European Union (28 member states); all the FCMs fall into these European pieces of legislation.

  • Under this the manufacturers hold the responsibility that end products comply with Article 3.
  • They have specific regulations, well established regulatory systems and well-formulated regulations on FCM supported by scientific evidence.
  • Article 3 states that the FCM must not transfer substances to food particles under normal or predictable use, which:-
    • Are a threat to human health.
    • Cause an undesirable change in the composition of foods.
    • Bring about damage or interfere with properties of food.

The Framework Regulation No. 1935/2004 is the basic community legislation that covers all the Food Contact materials and articles. It basically defines what exactly are “Food Contact Materials” and sets the basic requirement for these materials. Materials that are contact with the food particles i.e., the packaging they come in, the materials that come in contact post the packaging i.e., the containers, cups we put them in, even the inner walls of the refrigerator can be considered also the cardboard packaging some eatables come packed in.

  • They have 4 specific regulations on FCM (out of 17no. listed in Annex I) based on positive list of individual substances– 2004, amended from time to time.
  • Plastics (10/2011/EU), recycled plastics (282/2008/EC) ceramics (Directive 84/500/ EEC), regenerated cellulose (Directive 2007/42/EC) and active/ intelligent packaging materials (450/2009/EC). For these DOC is mandatory.
  • Specific measures on substances are present – i.e. positive list of monomers and additives.                               

The basic reason behind declaration of these regulations is to make sure that all the materials that are intended to come in contact with the food must be sufficiently inert so that excess migration does not happen which avoids to possibility of endangering the human health or bring about an unacceptable change in the food composition which changes the organic properties of the food particles present in it.

The purpose of this Regulation is also to ensure efficient functioning of the internal market regarding the materials which can be used with/along food particles and also stating a benchmark regarding the safety measures and ensuring a high level of safety.

The stated regulations are applicable on all the materials, articles i.e. including all the intelligent food contact materials; which in their finished state: -

Are intended to be brought into contact with food, are already in contact with food and were intended for that purpose, can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use.

The stated regulations are not applicable to: -

Materials which are supplied as antiques, Covering or coating materials for e.g., material coatings covering the prepared meat products or fruits, which form part of the food, Fixed public or private water supply equipment.

Community legislation on FCM covers the following: -

1. Materials already in contact (packaging of prepacked food)

2. Materials intended to come in contact with food (cups, utensils)

3. Materials expected to come in contact (table top, refrigerator walls-etc.)

4. Materials which are to be reasonably expected to come in contact with food. [global]

Basic requirements are set to ensure safe food: -

  1. FCM shall not endanger human health
  2. FCM shall not change the composition of food in an unacceptable manner
  3. FCM must not change taste, odour or texture of the food
  4. FCM must be manufactured according to good manufacturing practice (GMP)      

Exceptions from 2nd and 3rd are made for active materials and articles

GMP is stated under framework regulations.

A few of the highlights of EU regulatory system include: -

  • Labelling i.e. for the consumers to be informed/known for :-
  • The suitability of the product for food contact for which fig 1.0 is used.
  • The person responsible for manufacturing or placing on the market of the product.
  • The instructions for the safe use of the product.
  • Means of identification of the product for traceability.

Traceability i.e. a broad requirement arising from general food law that ensures, for example, batch retrieval in the event of a necessity. Labelling can take several forms: on the goods itself, on supporting paperwork, or on a sign beside the merchandise at the merchant. The consumer must not be misled by the information supplied on the label. Also, that the producer is responsible for putting all the details stated above along/on the packaging as per the declaration of compliance.

The Framework Regulations enable the European Commission to establish the material's needs/requirements. The specifications of the basic guidelines of the framework regulations are among these requirements/needs. The requirements can be set for various types of materials including plastics etc.

Specific requirements composed of

  • Authorisation of manufacturing processes or certain materials
  • Rules On Labelling and Compliance testing

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post submission support and technical liaison with authorities. 

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