Regulatory Compliance

1. FOOD STATUS
EU: ADMER™ is intended for use as an adhesive in multilayer structures. Following the definitions given in Commission Regulation (EU) No. 10/2011 and the Union Guidance to this Regulation published in November 2013 ADMER™, is a non-plastic intermediate for which a Declaration of Compliance as described in Annex IV to Commission Regulation (EU) No. 10/2011 does not have to be issued.

2. Compliance with Legislation Relevant to Electric and Electronic Equipment
All ADMER™ monomers and additives, if applicable, have been pre-registered both by Mitsui Chemicals Europe GmbH and our EU suppliers or non-EU suppliers (via Only Representative). Registration of the major monomers was done by Mitsui Chemicals Europe GmbH in September 2010. 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. Substances listed on the REACH Candidate List of SVHCs are not contained in concentrations above 0.1% by weight (Status 17.12.2015).

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) and in compliance with Automotive Lists, e.g. Ford, Toyota, Renault, GM etc.

4. COMPLICANCE WITH FURTHER LEGISLATION RELEVANT TO FOOD CONTACT MATERIALS:

  • Commission Directive 2006/125/EC as amended (Baby Food Directive)
  • Regulation (EU) No. 1169/2011 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

5. COMPLIANCE WITH LEGISLATION RELEVANT TO ELECTRICAL AND ELECTRONIC EQUIPMENT:

  • Directive 2011/65/EU as amended (RoHS2)
  • Directive 2012/19/EU as amended (WEEE)
  • Directive 2003/11/EC Brominated Flame Retardants

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
Most ADMER™ grades are 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 respective pharmaceutical product. We will support our customers in any of those approval processes if required. 

Please contact us for further details.

8. MEDICAL DEVICES
ADMER™ is a product dedicated to food packaging, automotive and industrial applications. We do not recommend to use ADMER™ in medical applications. It is the sole responsibility of the manufacturer of medical devices to ensure the suitability of raw materials for the intended application. We are willing to support our customers in approval processes after receiving prior written information on the details of such applications. Mitsui Chemicals Europe GmbH cannot assume any liability regarding the use of ADMER™ in medical applications or medical devices.

9. FURTHER LEGISLATIVE COMPLIANCE

  • Directive 2005/84/EC as amended (Phthalates in Toys and Childcare Articles)
  • Directive 2009/48/EC (Safety of Toys)
  • DIN EN 71-3 on Toys
  • Cosmetic Products Regulation (EC) No. 1223/2009
  • California Proposition 65 (Status: 4.12.2015)

Status: May 2016