In July 2019, the European Chemical Agency (ECHA) added four new substances to the REACH candidate list of Substances of Very High Concern SVHC, extending the list to a total of 201 substances. The candidate list describes substances that may have a negative impact on human health or the environment.
Producers, importers or suppliers of products that contain SVHC-listed substances are obliged to notify ECHA when they are located in the Europen Union, the total quantity of the listed substance used is more than one tone per year and/or the listed substance is present at more than 0.1% of the mass of one produced object.
See the full SVHC list here. It is frequently updated, last in july 2019. Find out all about ECHA and REACH in our previous blog post “How the European Union regulates Chemicals”. The four new substances included in the candidate list of Substances of Very High Concern (SVHC) are:
- 2-methoxyethyl acetate
- 4-tert-butylphenol
- Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)
- 3,3,3-tetrafluoro-2-(heptafluoropropoxy) propionic acid, its salts, and its acyl halides
The substances were included due to their toxicity for reproduction, endocrine disruption, and a combination of other properties.
The following list explains exactly why these specific substances were included:
2-methoxyethyl acetate
Application: Solvent for nitrocellulose, cellulose acetate, various gums, resins, waxes, oils, textile printing, photographic film, and lacquers.
Reason for inclusion: Toxic for reproduction Article 57 (c)
CAS NO: 110-49-6
Sweden initially proposed the substance to the SVHC’s listing.
4-tert-butylphenol
Application: Used in coating products, polymers, adhesives, sealants, and for the synthesis of other substances.
Reason for inclusion: Endocrine disrupting properties Article 57(f) – environment
CAS No: 98-54-4
Germany initially proposed the substance to the SVHC’s listing.
Tris(4-nonylphenyl, branched and linear)
Applications: Antioxidant to stabilize polymers.
Reason for inclusion: Endocrine disrupting properties Article 57(f) – environment.
France initially proposed the substance to the SVHC’s listing.
3,3,3-tetrafluoro-2-(heptafluoropropoxy)
Applications: Processing aid in the production of fluorinated polymers.
Reason for inclusion: Equivalent level of concern having probable serious effects to the environment Article 57(f) – environment. Equivalent level of concern having probable serious effects to human health Article 57(f) – human health.
What happens next?
Once the substances are on the SVHC List, companies may have legal obligations, which are described in detail here. These obligations apply to the listed substance on its own, in mixtures or in articles. Any supplier of articles containing a candidate list substance (above a concentration of 0.1 % w/w) has the obligation to inform customers down the entire supply chain and further any downstream user. This process is linked to safety data sheets.
Update your Safety Data Sheet
Article 31 of REACH states that affected companies must provide a safety data sheet, compiled in accordance with Annex II. The safety data sheet must be dated and shall contain the following headings:
Safety Data Sheet Headings
1. identification of the substance/preparation and of the company/undertaking;
2. hazards identification;
3. composition/information on ingredients;
4. first-aid measures;
5. fire-fighting measures;
6. accidental release measures;
7. handling and storage;
8. exposure controls/personal protection;
9. physical and chemical properties;
10. stability and reactivity;
11. toxicological information;
12. ecological information;
13. disposal considerations;
14. transport information;
15. regulatory information;
16. other information.
In particular, section 15.1 of the safety data sheet must be updated, if the product, mixture, or article contains a candidate list substance. Section 15.1 of the safety data sheet informs users about safety, health, and environmental regulations and legislations that apply to the specific substance, mixture, or article. This includes the question of whether the substance is subject to any prohibitions or restrictions in the country or region into which it is being supplied. Further, the safety data sheet must be in an official language of the member state where the substance is placed on the market. Companies which are producing, supplying or importing products that contain SVHC-listed substances in Europe are obliged to update the safety data sheet without delay
- as soon as new information which may affect the risk management measures, or new information on hazards becomes available,
- once an authorisation has been granted or refused,
- once a restriction has been imposed.
Moreover, importers and producers of articles containing the substance have six months from the date of its inclusion in the candidate list to notify ECHA. For the four substances listed above the six-month notification time period will end in mid-January of 2020. According to Article 31 (4) of REACH, the update of the safety data-sheet can be skipped if the “(…) dangerous substances (…) are provided with sufficient information to enable users to take the necessary measures as regards [to] the protection of human health, safety, and the environment unless requested by a downstream user or distributor.”
Our Standing
In every case, CheMondis supports any legislation that promotes sustainability along the industrial supply chain and beyond. We trust the assessment of the European Chemical Agency and comply with it.
On the marketplace, thousands of chemical products have already been uploaded, and more and more are following every day. As our approach to contribute to Article 30 of REACH, we take it upon us to raise awareness around it on our marketplace.
When uploading products onto CheMondis, sellers have the possibility to state if the specific product is bound to article 30 of REACH. This makes it easy for sellers to be transparent on their product content. Also, sellers on CheMondis can upload safety data sheets to all of their products.
All safety data-sheets are regularly examined by our chemical product managers as a double check to detect possible misunderstandings. Particularly the check of safety data sheets of products that contain SVHC listed products is mandatory to us.
We want to encourage sellers and buyers on CheMondis to comply with REACH regulations. Also, when buyers and sellers operate outside of the European Union. A number of countries outside of the European Union have started to implement REACH regulations as well or are in the process of adopting such a regulatory framework under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
China, the largest chemical manufacturer in the world, has also moved towards a more efficient and coherent system for the control of chemicals in compliance with GHS. Balkan countries such as Croatia and Serbia are in the process of adopting the EU REACH system under the auspices of the EU IPA program.
Switzerland has moved towards the implementation of REACH through partial revision of the Swiss Chemical Ordinance. Turkey has also paved the way to adopt REACH with the new Chemicals Management Regulation.
Now it is up to you
What do you think of the four new substances on the candidate list? Have you updated your safety data sheets yet? What do you think of section 15? And do you think Article 31 (4) of REACH is a free ticket for affected sellers? Let us know and leave a comment in the section below!
Thanks for taking the time to read the CheMondis Blog.
