Authorisation in REACH
The first step of the authorisation procedure in the REACH chemicals regulation is the identification of substances of very high concern (SVHC) and their inclusion in the Candidate List. For identification of SVHC substances ECHA or member states are preparing Annex XV dossiers.
SVHC substances are:
- Carcinogenic, Mutagenic or toxic to Reproduction (CMR),
- Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB),
- Other hazardous substances causing serious effects to human health or the environment (e.g. endocrine disrupters).
A public consultation has just been launched on proposals to identify nine new substances of very high concern (SVHCs) in the European chemical legislation REACH. The deadline for comments is 20 October 2017.
The substance names and examples of their uses are shown below:
- 4,4′-Isopropylidenediphenol (Bisphenol A) (EC 201-245-8). Used in the manufacture of polycarbonate, as a hardener for epoxy resins, as an anti-oxidant for processing PVC and in the production of thermal paper. Bisphenol A is already included in the Candidate List due to its toxic for reproduction properties and its endocrine disrupting properties with effects on human health.
- Chrysene (EC 205-923-4). Not registered under REACH. Normally not produced intentionally but rather occurs as a constituent or impurity in other substances.
- Benz[a]anthracene (EC 200-280-6). Not registered under REACH. Normally not produced intentionally but rather occurs as a constituent or impurity in other substances. Strong carcinogen
- Cadmium nitrate (EC 233-710-6). Used in laboratory chemicals and for the manufacture of glass, porcelain and ceramic products.
- Cadmium hydroxide (EC 244-168-5). Used in laboratory chemicals and for the manufacture of electrical, electronic and optical equipment.
- Cadmium carbonate (EC 208-168-9). Used as a pH regulator and in water treatment products, laboratory chemicals, cosmetics and personal care products.
- Tricobalt tetraoxide containing ≥ 0.1% w/w nickel oxides (EC 215-157-2). Used in laboratory chemicals, pH regulators and in water treatment products, semiconductors, polymers and coating products.
Dechlorane plus (structure from Pubchem)
- Dechlorane plus (including any of its individual anti- and syn-isomers or any combination thereof) (CAS 13560-89-9; 135821-74-8; 135821-03-3). Used as a non-plasticising flame retardant, used in adhesives and sealants and in binding agents.
- Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥0.1% w/w 4-heptylphenol, branched and linear] (EC – ). Used as a lubricant additive in lubricants and greases.
When the public consultation procedure is over, these chemicals may be listed in the Candidate List of Substances of Very High Concern for Authorisation.
The SVHC Roadmap 2020 aims to have all relevant SVHCs on the Candidate List by 2020.
Per September 2017 this Candidate List contains 174 entries (substances or groups of substances). The perfluoroalkyl substance PFNA was included in December 2015, PFDA in January 2017 and PFHxS in June 2017. In June 2017 also 4 phthalates (DEHP, BBP, DBP, and DiBP) were listed.
The next activity of the Authorisation procedure is the prioritisation of the entries on the Candidate List and transfer into the Authorisation List (Annex XIV).
ECHA regularly assesses the substances from the Candidate List to decide which ones should be included in the Authorisation List as a priority. This prioritisation is primarily based on the information in the registration dossiers on uses and volumes of the substance in the scope of authorisation. The latest assessment and recommendation for inclusion in the authorization list is from March 2017 contains 7 entries.
Per September 2017 there are 43 entries in the Authorization List with latest application dates and sunset dates:
Companies may request authorisation to use or continue to use substances on the Authorisation List.
Per September 2017 a total of 98 authorisations have been granted.
Restrictions under REACH
If a chemical poses an unacceptable risk that needs to be addressed on a EU-wide basis, a Member State or ECHA (on request of the Commission) may propose a restriction on the manufacturing, placing on the market or the use of that chemical of concern.
All the restrictions adopted in the framework of REACH and the previous legislation, (Directive 76/769/EEC) are included in Annex XVII to REACH.
Annex XVII includes per September 2017 65 entries (substances or group/family of substances), thus each entry can cover many single substances.
Among the newly restricted substances are bisphenol A in thermal paper, decaBDE as flame retardant in plastic and textiles and PFOA (see special newsblog).
Member countries may submit restriction proposals. In October 2015 the European Commission proposed to restrict 291 substances.
The Registry of Intentions to restrict had 35 entries in April 2017. In the same time ECHA submitted an intention to restrict 5 more entries a.o. the siloxanes: octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5), and the perfluorinated chemicals: PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA and PFTeDA, including their salts and precursors. In July 2017 five cobalt salts were included in the registry.
In 2016 ECHA has adopted a Community Rolling Action Plan (CoRAP) for 2016-2018 for evaluation of 138 priority substances by member states. CoRAP will regularly be updated, and the latest version covers 2017-2019 and contains 117 substances.
In 2016 and 2017, respectively, 39 and 22 substances was intended to be evaluated. The project is running somewhat slower than planned.