REACH Regulation (EC) 1907/2006
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the central EU chemicals regulation (EC) No 1907/2006, administered by ECHA (European Chemicals Agency) in Helsinki.
Relevant for manufacturers and importers of gloves and PPE:
1. SVHC (Substances of Very High Concern): substances classified as carcinogenic, mutagenic, reprotoxic (CMR), persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB). SVHC >0.1 % in articles must be notified to ECHA and published on the candidate list.
2. Restrictions (Annex XVII): certain substances may only be present in products up to defined limits. Relevant for gloves: phthalates (DEHP, DBP, BBP, DIBP) in PVC articles; polycyclic aromatic hydrocarbons (PAH) in rubber materials.
3. Authorisation (Annex XIV): certain SVHCs require authorisation from ECHA before industrial use.
Manufacturers and importers must ensure their products are REACH-compliant and maintain safety data sheets for contained chemicals where applicable.
Frequently asked questions
What are SVHC substances under REACH and why are they relevant for gloves?
SVHCs are substances of very high concern (carcinogenic, toxic for reproduction, persistent and so on). Those relevant to gloves are phthalates (e.g. DEHP in vinyl/PVC) and PAHs in rubber materials. Where an article contains a Candidate List SVHC above 0.1 % by weight, information duties towards customers and consumers apply (Art. 33) together with a SCIP notification to ECHA; a separate ECHA notification under Art. 7(2) is additionally required above one tonne per year.
Which phthalates are restricted in PVC gloves?
Under REACH Annex XVII (entry 51), DEHP, DBP, BBP and DIBP are restricted in articles containing plasticised material: individually or in combination no more than 0.1 % by weight of the plasticised material. For skin-contact PVC gloves this limit has applied since 7 July 2020. Medical devices are exempt from entry 51; instead the requirements of the Medical Device Regulation (MDR, Reg. (EU) 2017/745) apply, which sets its own labelling and justification duties where phthalates exceed 0.1 %.
Does REACH apply to medical devices?
Yes. REACH applies in principle to medical devices as well — they are not generally exempt (unlike medicinal products, which are largely exempt). The registration duty and the information duties on SVHCs (Art. 33, SCIP) apply without restriction. Medical devices are, however, exempt from the authorisation requirement for SVHCs (Annex XIV), and individual Annex XVII restrictions specifically exclude medical devices (for example the phthalate entry 51). Gloves are therefore subject to REACH requirements as articles — the detail depends on whether they are placed on the market as a medical device, as PPE or as a consumer article, and for medical devices the substance-related provisions of the MDR apply in addition.