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With regard to the exemption of medical devices and medical packaging from the REACH authorisation requirements specific to DEHP, a number of questions have been raised by stakeholders, for example: Are medical devices containing DEHP exempt from authorisation under REACH? And if so, does this exemption apply also to the upstream supply chain of the medical device producers? Are blood bags in fact medical devices? And is medical packaging containing DEHP exempt from authorisation under REACH?
Unless specifically exempt or specifically authorised, REACH authorisation is a ban on the use or application or incorporation into an article of a substance listed on Annex XIV of REACH and on placing the substance (on its own, in a preparation or incorporated in an article) on the market in the EU beyond the sunset date stipulated by the European Commission.
Medical devices are exempt from authorisation under Articles 60(2) and 62(6) of the REACH Regulation EC No 1907/2006. To quote:
a) Article 60(2): The Commission shall not consider the risks to human health arising from the use of a substance in a medical device regulated by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
This exemption is detailed further in Article 60(3) which states that the exemption only applies to substances that are classified as Carcinogenic, Mutagenic or Reprotoxic with a threshold (emphasis added), and does not apply to substances “having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties” (Article 60(3c)).
b) Article 62(6): The application [for authorisation] shall not include the risks to human health arising from the use of a substance in a medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC.
DEHP is subject to authorisation because of its Reprotoxic 1B classification, and as it is reprotoxic with a threshold, it is clear that medical devices containing DEHP are exempt from authorisation.
This position has been confirmed by a document produced by the Commission and presented for comment to CARACAL in October 2011. This confirmation also covers the incorporation of the substance into a medical device during the production process. The Commission's interpretation is in a Question and Answer format, and is expected to be published on the ECHA Frequently Asked Questions site in due course.
It should also be noted that blood bags are specifically defined as medical devices in Council Directive 90/385/EEC, annex IX (on the classification of medical devices) rule 18 which states “By derogation from other rules, blood bags are in class IIb”.
The exemption of medical packaging is specifically covered in Regulation 143/2011 which deals with the authorisation of DEHP:
In article 17 of the preamble to the regulation, the subject of medical packaging is introduced: “DEHP, BBP, and DBP are used in the immediate packaging of medicinal products. Aspects of safety of the immediate packaging of medicines are covered by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( 3 ) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 4 ). That legislation of the Union provides for a framework to properly control risks of such immediate packaging materials by imposing requirements on the quality, stability, and safety of the immediate packaging materials. It is therefore appropriate to exempt the use of DEHP, BBP, and DBP in the immediate packaging of medicinal products from authorisation under Regulation (EC) No 1907/2006.”
And in Regulation 143/2011 itself, the use of DEHP in the immediate packaging of medicinal products is listed under the exempt category of uses on page 5: “Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC”.
The plasticisers industry has been investing and developing alternatives to DEHP in medical devices. Today, other plasticisers such as Di-isononyl cyclohexanoate (DINCH), Tri-2-ethylhexyl trimellitate (TEHTM) and Dioctyl Terephthalate (DOTP) are being proposed in medical applications such as medical tubing and blood bags.