Regulatory Compliance

  1. Food status:

    Food status EU: Monomers and additives are listed as authorized monomers/additives in Annex I of Regulation (EC) No. 10/2011. Please refer to our Declarations of Compliance regarding substances restricted by SMLs.
    [Status: 14th January 2011]
    Dual Use Additives: Some ADMER® grades contain a Dual Use Additive subject to a restriction in food.
    USA: All ADMER® grades conform to FDA 21CFR, §175.105 (Adhesives) for indirect food contact. Some grades are also suitable for direct food contact. [Status: 1st April 2010]
  2. Compliance with Further Legislation Relevant to Food Contact Materials:

    Directive 96/5/EC as amended (Baby Food Directive)
    Directive 2003/89/EC as amended (Absence of Allergenic Food Ingredients)
    Directive 94/62/EC as amended (Packaging and Packaging Waste Directive)
    US CONEG
    French Décret No. 98/638
    Directive 2005/84/EC as amended (Absence of Phthalates)
    Directive 2009/48/EC (Safety of Toys)
    DIN EN 71-3 on Toys
  3. Automotive Applications:

    To help our customers verify compliance with ELV Directive 2000/53/EC and amendments we create Material Data Sheets in IMDS and send them to our customers. Our products are free of any declarable or prohibited substances according to GADSL (Global Automotive Declarable Substances List).
  4. Compliance with Further Legislation Relevant to Automotive Applications:

    Directive 2002/95/EC as amended (RoHS)
    Directive 2002/96/EC as amended (WEEE)
    Directive 2003/11/EC Brominated Flame Retardants
    Compliance with Automotive Lists, e.g. Ford, Toyota, Renault, GM etc.
  5. ADMER® - COMPLIANCE WITH REACH

    All ADMER® monomers and additives, if applicable, have been pre-registered both by MCE and our EU suppliers or non-EU suppliers (via Only Representative). Registration of the major monomers was done by MCE in September 2010. Further registrations will follow in 2013 and 2018, respectively.
    Some substances have been or will be registered by our suppliers. ADMER® is in compliance with the requirements of Annex XVII of the REACH Regulation (EC) No. 1907/2006.
    In the unlikely event that a substance contained in ADMER® should be listed on the REACH Candidate List of SVHCs we will inform our customers in due course.
  6. Pipe Applications

    Approval for the usage of certain ADMER® grades in pipe applications must always be obtained by pipe manufacturers. We will support customers in the pipe sector in that approval process by directly disclosing the required information to authorized testing laboratories on request.
    Evidence of ageing resistance of Admer pipe grades according to DVGW W542 and ISO2578 has been obtained.
  7. Pharmaceutical Packaging

    ADMER® is in compliance with the definition of polyolefins given in chapter 3.2 of the European Pharmacopoeia Monograph. Pharmaceutical packaging always has to be tested and approved together with the relevant pharmaceutical. We will support our customers in any of those approval processes if required.

 

For further details please contact your local sales office.

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"Should you require regulatory documentation, please get in touch with your local sales contact. We will be pleased to assist you!"

Dr. R. Doeller - Manager of Product Safety

Dr. R. Doeller
Manager of Product Safety

Sales Contact
 

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