The REACH Regulation and its Definition of Nanomaterials: What You Need to Know
REACH regulation uses the term Nanoform to define nanomaterial in Annex VI. The legal requirement under Annex VI of REACH is to report the number-based particle size distribution with indication of the number fraction of constituent particles in the size range within 1-100 nm. Nanomaterials are widely used in the automotive industry, cosmetics, electronics products, medicines, textile manufacturing and sports equipment. Smaller size and surface area make studies of the toxic effects of nanomaterials more challenging. Also, their properties can be more difficult to analyze than other chemicals. The European Union Observatory for Nanomaterials (EUON) has recently concluded that there are approximately 2200 products on the EU, EEA, and Swiss markets containing nanomaterials, of which 90 nanomaterial substances have not been listed in any of the inventories. As of 1 January 2020, legal requirements under REACH apply to all companies that manufacture or import nanoforms. Revised annexes to the REACH regulation describe these reporting obligations. Characterization of nanoforms is covered by registration and is defined under Annex VI Annex I outline chemical safety assessment Annexes III and VII-XI describe registration information requirements and Annex XII explains downstream user obligations For each form that qualifies as a nanoform, the manufacturer or importer must report in the registration dossier. Also, they must make sure that a corresponding hazard dataset is submitted. As a consequence of the REACH regulation, companies must submit a great deal of information in their registrations. Companies must provide information on their nanomaterials’ properties, manufacturing processes, and intended use. Moreover, companies must also provide information on human and environmental health risks associated with their nanomaterials. Due to their wide applications in society and our increased exposure to them, it is important to understand potentially harmful effects they might have on our health and how regulatory bodies acts. We offer a team of REACH compliance experts who can assist you in understanding the regulations and ensuring your company stays in compliance. ComplianceXL enables you to concentrate on your business while we handle compliance requirements.
All you need to know about REACH SVHC update 2022
On January 17, 2022, ECHA added four more substances to its list of SVHC candidates, which was updated from 219 to 223. The chemicals contain hormone-disrupting properties, interfere negatively with reproductive health, are bioaccumulative, toxic, persistent, and biodegradable, which makes them harmful to humans and the environment. There are four substances listed on the Candidate List, one of which is used in cosmetics and may disrupt human hormones. In addition to these, there are two that are used in rubber, lubricants, and sealants, and which are included because they are detrimental to fertility. There is a fourth chemical that is used in lubricants and greases, and it has been added because it is persistent, bioaccumulative, and toxic (PBT), and therefore is harmful to the environment. Below are the newly added 4 chemicals in the SVHC List: tris(2-methoxyethoxy)vinylsilane: CAS number is 1067-53-4. Inclusion is due to the fact that this substance is potentially toxic for reproduction. The substance acts as a coupling agent. According to Article 57CC, the reason for inclusion is that these chemicals are toxic for reproduction. They can be found in rubber, lubricants, adhesives, inks, and fuels. (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC): As per Article 57 f – human health, the reason for inclusion is Endocrine Disrupting Properties. This substance is used in cosmetics. 6,6′-di-tert-butyl-2,2′-methylenedi-p-cresol: CAS number is 119-47-1. The reason for inclusion is Toxic for reproduction, as per Article 57 c. It is used in rubbers, plastics and sealants products. S-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate: CAS number is 255881-94-8. As stated in Article 57d, the reason for inclusion is the persistent, bioaccumulative and toxic nature of the substance. It is commonly found in greases and lubricants. By adding these substances to the EU REACH SVHC List, the total REACH SVHC List now stands at 223 substances. Prior to this addition, SVHC 219 was added in July. Substances that are added to the EU REACH SVHC List come with immediate obligations for affected companies who use the substances in their products above the agreed threshold, which includes notifying their customers and informing ECHA through submissions to the SCIP Database. We at ComplianceXL help organizations coordinate this process from start to finish, including coverage for the SCIP Database, by performing data collection, data validation, substance calculations, and report generation as part of our EU REACH data services. Find out more about what we can do for your company in relation to EU REACH compliance by getting in touch with us today.
Alert EU REACH SVHC List updated – ECHA adds 4 new substances
On 5 January 2020, the European Chemicals Agency (ECHA) announced 4 new additions to the REACH candidate list of Substances of Very High Concern (SVHCs) having below properties Carcinogenic Mutagenic and reprotoxic (CMR) Persistent, bioaccumulative and toxic (PBT) Very persistent and very bioaccumulative (vPvB) substances The inclusion of perfluorobutane sulfonic acid (PFBS) and its salts was decided with the Involvement of the Member State Committee (MSC). The PFBS and its salts were added due to its Equivalent level of concern, having probable serious effects on human health and to the environment as per Article 57(f) (human health and environment). With this addition, the The Candidate List of substances of very high concern (SVHCs) for authorisation now contains 205 substances. The new substances included in the Candidate List are: Diisohexyl phthalate: CAS# 71850-09-4 – Diisohexyl phthalate is added because of Its reproductive toxicity as per Article 57(c). 2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone: CAS#119313-12-1 – This substance is also toxic for reproduction as per Article 57(c) and is used in in polymer production. 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one: -CAS# 71868-10-5 – This substance used in polymer production is included because it has reproductive toxicity property as per Article 57(c). Perfluorobutane sulfonic acid (PFBS) and its salts: It’s added because of its serious effects on the Environment as well as human health, as per article 57(f). It’s used as a catalyst/additive/reactant in polymer manufacturing and the synthesis of chemicals. It’s also used as a flame retardant in polycarbonate for electronic equipment. Manufacturers producing or selling products containing these substances in the EU must disclose the presence of SVHCs above 0.1% (w/w) within six months of the latest update on January 16, 2020. The SVHC list get updated frequently with inputs from the Member State Committee. All manufacturers/suppliers should keep a track of the SVHC list to stay compliant and avoid business continuity risks. Do you want to know whether you are compliant to the latest Update? Talk to our Compliance Experts today! Write us at [email protected].
2 Potential SVHCs for REACH Candidate list, June 2015
The 13th version of the REACH Candidate List (CL) is expected to be published in June 2015 with more additions. Since suppliers or product manufacturers are continuously monitoring the CL to keep their product in compliance with REACH, it’s always good to know the Substances of Very High Concern (SVHCs) earlier to start the proceedings. Only two substances have been proposed for inclusion as SVHCs this time by the member states.