Pharma

Healthcare

Food

Cosmetics

CERTIFICATE AND COMPLIANCE

Healthcare

CERTIFICATE AND COMPLIANCE
All equipment is with CE-certificate and in compliance with current European law and standards.

Healthcare product comes into contact with many materials and articles during its production, processing, storage, preparation and serving, before its eventual consumption. Such materials and articles are called Food Contact Materials (FCMs). product contact materials are either intended to be brought into contact with product, are already in contact with product, or can reasonably be brought into contact with product or transfer their constituents to the product under normal or foreseeable use. This includes direct or indirect contact. Examples include:

  • containers for transporting product
    • machinery to process product
    • packaging materials

The term does not cover fixed public or private water supply equipment.
FCMs should be sufficiently inert so that their constituents neither adversely affect consumer health nor influence the quality of the food. To ensure the safety of FCMs, and to facilitate the free movement of goods, EU law provides for binding rules that business operators must comply with.
The EU Rules on food contact materials can be of general scope, i.e. apply to all FCMs or apply to specific materials only. EU law may be complemented with Member States national legislation if specific EU rules do not exist.

The safety of FCM is evaluated by the European Food Safety Authority (EFSA). At EFSA’s website you can search for opinions on substances to be used in food contact materials.

The safety of Food Contact Materials is tested by the business operators placing them on the market, and by the competent authorities of the Member States during official controls. Scientific knowledge and technical competence on testing methods is being maintained by the European Reference Laboratory for Food Contact Materials (EURL-FCM). Its website provides guidelines and other resources concerning the testing of food contact materials.

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