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Regulatory Compliance

1. FOOD CONTACT 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. To support our customers in their compliance work we provide adequate information for that purpose.

2. Reach
All substances subject to registration requirements have been registered. 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.

3. AUTOMOTIVE APPLICATIONS
To help our customers verify compliance with requirements relevant in the Automotive industry (such as ELV Directive 2000/53/EC and the Global Automotive Declarable Substances List, GADSL) we create Material Data Sheets in IMDS and send them to our customers on request.

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

  • 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)

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

  • DIN EN 71-3 on Toys
  • Cosmetic Products Regulation (EC) No. 1223/2009
  • California Proposition 65 (Status: November 17, 2023)

Status: December 2023