Regulation (EC) No. 1907/2006 (REACH) is a constantly growing and changing construct. It applies to all chemical substances and mixtures found in everyday life, such as in cleaning agents or paints, but also in electronic devices and components, textiles or furniture. The REACH regulation affects both private and industrial applications and therefore involves most companies in the EU. The only exceptions are radioactive substances, substances used in pharmaceuticals, non-isolated intermediates and other areas of application regulated by other legislation.
The REACH regulation serves to identify and register, evaluate, authorize and restrict hazardous substances. In doing so, companies have to fulfill various obligations. They must disclose the risks of the substances and mixtures manufactured or used to the European Chemicals Agency (ECHA) and, if necessary, provide downstream users with information on safe handling.
The core elements of the regulation are:
- Candidate List
- REACH Article 33 information requirement on substances in articles
- Bi-annual extension
- Annex XIV
- List of substances subject to authorization
- Annex XVII
- List of general restrictions for substances
Upstream of these lists is a complex process in which substances to be regulated are discussed and evaluated across multiple bodies.
Extension of the candidate list with new substances
In this young year of 2023, a lot has already happened. On January 17, 2023, the candidate list was expanded by 14 entries and thus the following substances:
- 1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]
- 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol
- 4,4'-sulphonyldiphenol
- Barium diborone tetraoxide
- bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof
- Bis(2-ethylhexyl) tetrabromophthalate
- Isobutyl 4-hydroxybenzoate
- Melamine
- Perfluoroheptanoic acid and its salts
- ammonium perfluoroheptanoate
- potassium perfluoroheptanoate
- Perfluoroheptanoic acid
- Sodium perfluoroheptanoate
- reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine
Note: 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol or also "tetrabromobisphenol A/TBBA" is proposed for restriction under Directive 2011/65/EU (RoHS).
New PFAS restriction proposal
Per- and polyfluoroalkyl substances (PFAS) are a large group of chemicals that are very persistent in the environment and are also referred to as "eternal chemicals." The reason for this is their fully fluorinated hydrogen atoms, which give their structure a very strong chemical bond. As long as PFAS continue to be used, humans, animals and nature are exposed to them. Due to their high mobility in water and air, PFAS contaminate groundwater and drinking water. They are already present in remote environments such as the Arctic and Antarctic and in higher atmospheres. Contamination can be irreversible and cause health problems.
Some PFAS are already banned globally by the United Nations Stockholm Convention on Persistent Organic Pollutants, implemented in the European Union by (POPs) Regulation (EU) 2019/1021. Other proposed restrictions on members of the PFAS family are still under discussion. Since the banned long-chain PFAS have been replaced by not yet banned short-chain members of the same group in many applications, but which are no less hazardous, two restriction proposals have been made for the whole group.
- PFAS in firefighting foams
- PFAS in general
The restriction proposal for firefighting foams was created earlier and paves the way for the general restriction proposal for various uses. The proposals cover the entire PFAS group, which includes over 10,000 substances, making them the most comprehensive restriction proposals to date. It is estimated that 4.4 million metric tons of PFAS will be released into the environment over the next 30 years unless restrictions are put in place.
PFASs are used in the following products, among others:
- Rainwear, textiles and surface treatments
- Non-adhesive coatings for pans and pots, food packaging
- Fire-fighting foams
- Chrome platings, paints and building materials
Identified hazards of some PFAS:
- Reproductive hazard and harm to the fetus
- Possibly carcinogenic
- Influence on the endocrine system
- Harmful to bones, liver, kidneys and other organs
Next steps in the general PFAS restriction proposal:
- March 22, 2023: Start of 6-month public consultation period
- April 5, 2023: ECHA online information event for interested parties to the consultation
- Opinion formation of the ECHA Committees
- Committee for Risk Assessment (RAC)
- Committee for Socio-Economic Analysis (SEAC)
- Communication of the elaborated restriction proposal to the European Commission
- Discussion of the proposal by the European Commission and the Member States
Review of the safety data sheets
As part of ECHA's "harmonised enforcement project (REF-11), the compliance of safety data sheets on chemicals will be reviewed by national enforcement authorities across the EU this year. The main objective is to check compliance with Annex II of the REACH Regulation. This includes, among other things, the provision of REACH registration numbers. If the registration has not been carried out properly, this could have an impact on the supply chain, as REACH Article 5 states that the principle of "no data, no market" applies.
Conclusion
In summary, there is a tendency towards group consideration. As a result, a whole series of substances are regulated with one entry in one of the lists. Transparency about hazardous chemical substances is increasingly in focus internationally.
We recommend companies to strengthen their material knowledge in order to be able to react to potential substance restrictions or bans at an early stage. For further details or queries we are at your disposal, just contact us!
