by Tatjana Benko
On 16 January 2020, four new substances were added to the Candidate List for Authorisation (also known as substances of very high concern (SVHCs)). Three substances were added due to concerns over toxicity to reproduction and one substance was added due to probable serious effects to human health and the environment.
|1||71850-09-4||276-090-2||Diisohexyl phthalate||Toxic for reproduction|
|2||119313-12-1||404-360-3||2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone||Toxic for reproduction|
|3||71868-10-5||400-600-6||2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one||Toxic for reproduction|
|4||–||–||Perfluorobutane sulfonic acid (PFBS) and its salts||Equivalent level of concern having probable serious effects to the environment
Equivalent level of concern having probable serious effects to human health
Additional information requirements apply to Substances listed on the Candidate List and are as follows:
Notification and communication obligations of the Candidate List substance in articles
- The manufacturer and importers of articles need to notify to ECHA substances listed on the Candidate list if they:
- are present in an article in a concentration greater than 0.1% (w/w) and
- the total quantity of the substance across all uses exceeds 1 tonne per year.
Notification of substance in articles should be done at the latest 6 months after it has been included in the Candidate List (so for these new substances added, one has until 16 July 2020 to notify).
- Information on the Candidate List substances present in articles needs to be communicated down the supply chain if substance concentration is greater than 0.1% (w/w). This information also needs to be provided to consumers within 45 days upon request.
Safety Data Sheets update
- Suppliers of substances listed on the Candidate List have to provide the Safety Data Sheet (SDS) to customers. Information on substances listed on the Candidate list should be included in Section 15 (Regulatory information) of the SDS.
- Suppliers of mixtures not classified as hazardous according to the CLP Regulation (EC) No 1272/2008 have to provide SDS to customers, upon their request, if the mixture contains a substance listed on the Candidate List in concentration ≥ 1% (w/w) for non-gaseous mixtures and ≥ 0.2% by volume for gaseous mixtures.
As of January 16, 2020, the Candidate List of substances of very high concern (SVHC) contains 205 entries. As such, substances on this list are candidates for eventual inclusion on the Authorisation list. Once on the list, manufacturers or importers of such substances would need to apply for permission to continue use of the substance after its published sunset date.
Recommended Action Items:
- Review your products composition and determine if your product contains substances listed on the Candidate list of SVHC for Authorisation.
- If your product/article contains substance listed on the Candidate list, then investigate suitable alternatives.
- Notify and communicate to your users if a substance on the Candidate List substance is in your manufactured article.
- Update the Safety Data Sheet, if needed
The LOLI® Database
UL’s industry-leading LOLI Regulatory Database (List of Lists) is an unprecedented, high-quality structured source of information that connects the restrictions and conditions in regulations to the chemical substances and families to which they apply.
As government and advisory agencies (as well as advocacy groups and brands) issue their policies in many languages and formats, which are then dispersed online and via various physical mediums, LOLI is a single and structured source for the substance-specific data points you need for hazard assessment and product compliance around the world.
LOLI Illuminator is the latest evolution in access to the LOLI Database, providing personalized views and automated change alerts for chemical regulatory data, including a “radar” for monitoring your substances of concern.
For personalized alerts of changes like this one, we recommend adding the following lists to your Collections in LOLI Illuminator:
- Candidate List of substances of very high concern for Authorisation: https://echa.europa.eu/candidate-list-table
- REACH, SVHC, Authorisation, Candidate List, EU, European Union
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