Limitation of substances of very high concern in components in contact with tissue and body fluids
Level: Core
The purpose for this criterion is to minimise contents of carcinogenic, mutagenic and reprotoxic (CMR) substances on the REACH Candidate List.
Details
- Type:
- Award criteria
- ID:
- 11354
- Group:
- General criteria
Criterion text
Points are awarded if the parts of the equipment and medical supplies that are in contact with tissue and body fluids are free from substances classified with the hazard phrases below, as specified in Regulation (EC) No 1272/2008 of the European Parliament on classification, labelling and packaging of substances and mixtures (the CLP Regulation). The concentration shall not exceed 0.1% by weight per substance in each individual part of the product.
| Classification according to regulation 1272/2008 | |
| Hazard class and category | Hazard phrase |
| Carcinogenicity | H350 |
| Mutagenic | H340 |
| Reproductive toxicity | H360 |
Verification
Supplier certificate that proves that the product or medical supplies do not contain CMR-substances above 0.1% by weight in product parts that will come into contact with tissue and body fluids. The certificate must be signed by the authorized representative of the supplier.
Upon request from the contracting authority, supporting technical documentation shall be shown. The contracting authority may also request random testing to be performed by an independent laboratory or other testing institute.
Proposed follow-up
Check technical documentation or test protocols, which shows that the products or supplies do not contain any CMR-substances above 0,1 % by weight.
For medical supplies that are delivered continuously during the contract period, the contracted authority can take random samples for analysis to check compliance with the criteria.
Motive
The medical device regulation (EU 2017/745) limits the presence of CMR substances in contact with the body to 0.1% by weight, from May 2020. Although, the regulation allows a possibility for exceptions in limited cases. Due to the serious properties of the CMR, it is warranted to set the requirement without exceptions.
Carcinogenic, mutagenic and reprotoxic substances are so dangerous that humans should not be exposed to them. In theory, one exposure to a very low dose of some CMR-substances could cause irreversible damages. It could be for example reproductive damages (fertility or embryo/foetus/child development), or damages which in the long term could develop into cancer.
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 11354
- Version date
- 2019-06-03