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With the publication of entry 78 in Annex XVII of the REACH Regulation, the European Union has enacted one of the most far-reaching regulations to curb microplastics. Since 17 October 2023, the placing on the market of synthetic polymer microparticles (SPM) has been banned in many applications – and the medical device industry is not unaffected.
This means that there is an acute need for manufacturers to take action: Which products are affected? What exceptions exist? And how can material compliance and market access be secured in the long term?
What is regulated?
Since 17 October 2023, entry 78 prohibits the placing on the market of synthetic polymer microparticles (SPM) – either as a substance of their own or in mixtures if the concentration exceeds 0.01% by weight. The definition of the particles concerned is precise:
Solid according to physical definition.
Contained in particles or present as a continuous surface coating on particles, where:
the polymer makes up at least 1 % of the particle weight and
at least 1 % of the particles either:
have all dimensions ≤ 5 mm or
have a length ≤ 15 mm and a length-to-diameter ratio > 3 (fibre-like).
Natural, non-chemically modified polymers and polymers that are either biodegradable or water-soluble (more than 2 g/L) are excluded. Polymeric structures without carbon content are also not covered by the regulation.
Medical devices in focus: exemptions and deadlines
The regulation sets out specific rules for medical devices. Medicinal products for human and veterinary use that fall under Directive 2001/83/EC or Regulation (EU) 2019/6 are completely excluded from the scope of entry 78. No additional proof is required here.
The situation is different for medical devices within the scope of Regulation (EU) 2017/745 that are placed on the market in material or liquid form – i.e. as a substance or mixture. A transition period of six years applies to these products. They may continue to be sold until 17 October 2029, provided no other restriction applies.
After the end of the transition period, affected products must either
be free of SPM or have a concentration below 0.01 per cent by weight limit,
are based on degradable or water-soluble polymers – with corresponding proof,
or fall under one of the derogations provided for in the Regulation (paragraphs 4 or 5).
The permitted exceptional uses include applications in which the particles are completely retained by technical means (e.g. in filters), permanently change their physical structure during use (e.g. by coalescence into a film), or are bound into a solid matrix (as in fibre-reinforced implants).
Medical device with or without microplastics? The clock is ticking for the changeover. (Source: ECHA)
Obligations exist even with exceptions
It is of central importance that even if a medical device remains authorised as an exception, this does not exempt it from all regulatory requirements. For example, the following obligations apply:
Information obligation (IFUD) according to paragraph 7:
Manufacturers must provide suitable instructions for safe use and disposal, especially if release of the particles cannot be ruled out when used as intended. The obligation to provide information applies to industrial as well as professional and private applications. An example of this is an absorbable wound gel that disintegrates during use – it must be clear from the product information that no environmentally relevant particles are released.
Reporting obligation according to paragraph 12:
When supplying to professional users or end users, an estimate of the quantities of SPM released must be made annually and reported to the competent authority. This usually concerns the first actor in the EU supply chain, such as the manufacturer or importer.
Obligation to provide evidence:
It must be possible to document the utilisation of an exemption in a comprehensible manner upon request. In this context, authorities expect technical information on particle size, physical incorporation in the product and, if applicable, release analyses or proof of use.
 Guidance documents were recently published by the EU Commission for the implementation of the obligations.
Compliance does not start with CE labelling
The REACH restriction on microplastics is not a quick fix, but an expression of the EU’s long-term environmental strategy. For manufacturers of medical devices, this means a new dimension of regulatory due diligence obligations – with a direct impact on product development, market access and strategic risk management.
In order to set the right course for material compliance at an early stage, it is worth developing a robust material compliance strategy. seleon supports manufacturers in this process with individual workshops, portfolio analyses and practical implementation support.
Please note that all details and listings are not intended to be exhaustive, are without guarantee and are for information purposes only.
