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.
REACH Requirements and Chemical Recycling
“Chemical Recycling of Polymeric Waste in the Circular Economy” was a report published by ECHA to examine the current state of chemical recycling from plastic, rubber, and other polymeric waste materials. In its report, the commission outlines recommendations and conclusions that must be followed in order to perform chemical recycling and reduce plastic pollution. As part of chemical recycling, plastic polymers are chemically broken down to produce new products, such as crude oil, fuels, which can be used in new plastic production. Mechanical recycling, which consists of mechanically crushing the plastic into granules, has been replaced by chemical recycling. It is possible to recycle both mixed plastic waste and contaminated plastic waste through chemical recycling. Recommendations and Conclusions of Chemical Recycling Study A total of 6 conclusions and 4 recommendations were made in the study. At the moment, scientific papers do not mention the regulatory aspects of chemical recycling. REACH and other chemicals, waste and product safety legislation present opportunities and challenges specific to each chemical recycling technology. Consequently, the report recommends that regulatory issues be examined on a case-by-case basis, separately for each type of chemical recycling technology. The report also summarizes feedback from operators on the challenges associated with each recycling technology. Only a limited amount of knowledge exists about the potential of different chemical recycling processes to eliminate substances of concern. Further studies at chemical recycling facilities are necessary to reach sound conclusions. The circularity of plastics can be achieved using a variety of chemical recycling processes. In order to avoid false generalizations on one technology’s pros and cons for the entire field of chemical recycling, each technology should be evaluated individually. Through digital technologies, the traceability of substances of concern in recycling can be improved. Their implementation, however, requires that a lot of effort and coordination be made between and within organizations. The lack of clarity in chemical recycling terminology creates confusion about chemical recycling’s potential in the circular economy. The term chemical recycling should be harmonized so that a consistent discussion can be held regarding chemical recycling potential. To distinguish technologies that meet the definition of recycling, outlined under the Waste framework directive, chemical reprocessing technologies should always be mentioned in reports and regulatory documents. The use of Block chain technology can be used to monitor substances of concern in plastic waste. However, its implementation requires substantial efforts on the part of companies to implement it. ECHA mentions that it is critical to understand the different methods for recycling chemicals. By using these techniques, it will be possible to reduce the presence of harmful substances in recycled materials. This will lead to a no-toxic cycle in the circular economy. In addition, ECHA would like to know how many new REACH registrations will be created. The report outlines the advantages and disadvantages of different chemical recycling processes. Talk to our Global Compliance specialist to understand how this new chemical recycling requirements affect your organization.
All you need to know about PFCAs restricted by EU under Annex 17
PFCAs (perfluorocarboxylic acids), a subset of PFAs (per- and polyfluoroalkyl substances) has been restricted by European commission – under Annex XVII of REACH Regulation. This new regulation replaces the entry 68 of Annex 17 to REACH on PFOA. PFOA related substances are now regulated under POPs regulation (EU) 2019/1021. It restricts the PFCAs and their salts, containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs). The below substances are excluded from the definition: CnF2n+1-C (= O) OX’ where n> 13 and X’=any group, including salts CnF2n+1-X, where X = F, Cl, or Br where n = 9, 10, 11, 12, 13 or 14, including any combinations thereof. Companies cannot manufacture, use or place the PFCAs and their salts on the market from 25th Feb 2023. These are toxic and very persistent and very bioaccumulative (vPvB). C9-C14 PFCAs act as a substitute for PFOA. This is also added under Candidate List as substances of very high concern (SVHCs) under REACH. It can be used as a constituent in other substances, mixtures or articles, if the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances. The regulation is applicable from 4th July 2023 to: Textiles for oil – and water repellency for protection of workers from dangerous liquids. The manufacturer of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF), used in the production of: Industrial sealants capable of preventing volatile organic compound leakage. Equipment for industrial waste heat exchange. Membranes used in corrosion resistant gas filters, water filters and medical devices. The regulation is applicable from 4th July 2025 for: Photographic coatings applied to films. Implantable and invasive medical devices. Fire-fighting foam for liquid fuel vapor suppression and liquid fuel fire for Class B fires. photolithography or etch processes used in the manufacture of semiconductors. Different transition periods are granted to certain industry and professional. Articles placed before 25th of Feb 2023 on EU market are exempted. Talk to one of our REACH Regulation Specialists today!
Perfluorooctanoic acid (PFOA)- Restrictions and deadline
Per-and polyfluoroalkyl substances (PFAS) are a large family of synthetic chemicals widely used in the society. PFOA is one of those families present in PFAS. Since they contain Carbon chain of different lengths and the Hydrogen atoms are completely or partly substituted by Fluorine atoms, they form a very stable bond and are not degradable in the environment. PFOA can be found in Non-stick pans, furniture, cosmetics, household cleaners, clothings, packaged food containers, furniture treatments products, food wraps, sprays for leather, shoes and paints. EU has taken a regulatory approach to reduce the usage of PFOA and its salts under Annex I to Regulation (EU) 2019/1021.PFOA is considered as a substance of concern because of 2 main reasons. Toxic for reproduction Persistent, Bioaccumulative and Toxic Substance Perfluorooctanoic acid has CAS number 335-67-1.PFOA salts and polymers comes with formula C7F15- , C8F17- .Below are the substances that are excluded from this designation:— C8F17-X, where X is F, Cl, Br. — C8F17-CF2-X′ or C8F17-C(=O) OH, C8F17-C(=O )O-X′ (where X′ is any group, including salts). Important dates: 4 July 2020 PFOA should not be used in equal to or more than 25ppb including its salts or 1000ppb of one or a combination of PFOA related substance in any substance/constituent, mixture or article. 4 July 2022 This rule will apply to the equipment used to manufacture semi-conductors and latex printing inks. 4 July 2023 The rule will apply to textiles for the protection of workers, and membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment, and plasma nano-coatings. 4 July 2032 The rule applies to medical devices other than implantable medical devices within the scope of Directive 93/42/EEC. The US Environmental Protection Agency also regulates PFOA. On Feb 20,2020, EPA proposed regulatory determinations for perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in drinking water. On March 10 2020, EPA issued initial regulatory determination under the safe drinking water act (SDWA) for PFOS and PFOA. They also started 60 -day public comment box which expired on May 11,2020. The public comment period is for interested parties to submit the input to EPA regarding on adverse health effect of substance, frequency of presence of this substance in water and health risk. A negative finding will lead to withdrawing preliminary determination. Our REACH compliance experts keep a tab on developments on REACH regulation and help organisations meet their compliance requirements. Our expertise combined with consultancy services and experience in consumer product supply chain provides an edge in understanding the specific requirement in such cases. Would you like to learn more about how ComplianceXL can support your REACH compliance activities? Talk to our compliance specialists today!
REACH AUTHORIZATION LIST – 18 NEW SUBSTANCES
On 1ST Oct ,2019, European Commission recommended 18 substances of very high concern for (SVHC) to be added in REACH authorization list. These substances are reproductive toxicants, endocrine disruptors, carcinogens, very persistent and very bio accumulative (vPvB) substances or respiratory sensitizers. They are prioritized due to their high volume and widespread use that can be a threat to human or environment. The European Commission in collaboration with the Member States and the European Parliament, will take final decision on the inclusion of the substances in the Authorization List and on the dates by which companies will need to apply for authorization to ECHA. List of 18 substances included in the ninth recommendation: 4,4′-isopropylidenediphenol (Bisphenol A; BPA) – Toxic for reproduction, Endocrine disrupting properties in human health and environment. It’s found in Epoxy resin hardeners. 1,6,7,8,9,14,15,16,17,17,18,18- Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca7,15-diene (“Dechlorane Plus”™) has got vPvB properties .It’s a Flame retardant in adhesives and polymers. 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 (4-Hbl) has Endocrine disrupting properties. Affects environment. Used in Lubricants and greases. 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5- dithia-4-stannatetradecanoate (DOTE) is toxic for reproduction. Found as stabilizer in polymers. Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7- oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2- ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2- oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4- stannatetradecanoate (reaction mass of DOTE and MOTE) – is toxic for reproduction. Found as stabilizer in polymers. 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2) has carcinogenic properties. Available in printing inks. Dioxobis(stearato) trilead is toxic for reproduction. Used as stabilizer in PVC. Fatty acids, C16-18, lead salts are toxic for reproduction. Used as stabilizer in PVC. Trilead dioxide phosphonate is toxic for reproduction. Used as stabilizer in PVC.; rubber production; mirror backing. Sulfurous acid, lead salt, dibasic has reproductive toxicity. The substance has no registered uses but is recommended based on grouping considerations as it could potentially replace other lead stabilizers in some of their uses. This is to avoid regrettable substitution. [Phthalato(2-)]dioxotrilead has reproductive toxicity. The substance has no registered uses but is recommended based on grouping considerations as it could potentially replace other lead stabilizers in some of their uses. This is to avoid regrettable substitution. Trilead bis(carbonate) dihydroxide is Toxic for reproduction. Found in Artists’ paints. Lead oxide sulfate is Toxic for reproduction. Used in Mirror backing. Cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans-cyclohexane-1,2-dicarboxylic anhydride [3] (HHPA) has respiratory sensitising properties. Found in epoxy resin hardeners. Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro-1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] (MHHPA) has respiratory sensitising properties. Found in epoxy resin hardeners. Tetraethyllead is Toxic for reproduction. Found as an additive in aviation fuel. 2-methoxyethanol is Toxic for reproduction. Used as a solvent. 2-ethoxyethanol is Toxic for reproduction. Used as a solvent. Once the final dates are out, the selected companies will compulsorily need to apply for Authorization to ECHA. The inclusion of these substances will avoid any further damage and the substances then will be safe to use. Talk to our REACH Compliance Experts – +1 872 529 6162 or Email us at [email protected].
Reach SVHC List updated-Four new substances added
On 16th July, the European Chemical Agency (ECHA) has updated REACH SVHC list by adding 4 new substances having properties given below. Toxicity to reproduction Endocrine disruption Very Persistent and Very Bioaccumulative (vPvB) substances Persistent, Bioaccumulative and Toxic (PBT) The decision to include the substances Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) and 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy) propionic acid, its salts and its acyl halides was taken with the involvement of the Member State Committee (MSC). The new substances included in the Candidate List are: 2-methoxyethyl acetate Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) 4-tert-butylphenol The last substance on the list that is 4-tert-butylphenol has been added to the list after it was identified as an SVHC by the EUROPEAN commission due to the endocrine disrupting properties it holds. The substances mentioned above are usually used as antioxidants to stabilize polymers, in coating products, polymers, adhesives, as a processing aid in the production of fluorinated polymers and for synthesis of other substances. It is mandatory for any organization dealing with these products in the European Union to communicate the presence of SVHCs in their products above the concentration of 0.1% (weight by weight) within six months of date of substance inclusion in the candidate list by ECHA, for which the latest update is 16th July, 2019. To avoid business continuity risks and to stay compliant, it is best to keep an active check on ECHAs SVHC list. This addition made an increase in total SVHC from 197 to 201. For more information on these obligations, talk to our REACH compliance expert – Call +1 872 529 6162
REACH Compliance – FAQ
EU Reach plays a vital role in keeping a check on the risks of hazardous materials that affect human health and the environment. We bring you a list of FAQ’s to help you stay updated on regulatory compliance and be compliant in all forms. 1. What is REACH? REACH is a new European law regulating the use and production of chemical substances. 2. Who will pay for the risk assessment that has to be done in accordance with REACH? Those who import or produce a new chemical must pay the costs for the testing of the chemical. 3. What are the implications of REACH for animal testing? Animal testing will increase significantly due to all the chemical tests that have to be carried out. However, officials from the European Commission have stated that an increase in animal testing of almost four million more animals was not “ethically defensible” and that there are plans to reduce this high number by almost 70%. 4. How many chemicals will have to be registered? Within the 11 years of implementation of REACH, approximately 30,000 chemicals have to be registered. Those being most hazardous or existent in the largest quantity will go first. 5. What are substances of very high concern (SVHCs)? Substances that are one of the following: carcinogenic, mutagenic or toxic to reproduction (CMRs) persistent, bio-accumulative and toxic (PBTs) very persistent and bio-accumulative (vPvBs) seriously and / or irreversibly damaging the environment or human health, as substances damaging the hormone system The general aim of REACH is to replace these potentially very hazardous substances by safer alternatives whenever possible. If this is not possible, in exceptional cases hazardous substances can be authorized if the registrant can prove that an adequate risk control is guaranteed the benefits for the society or the economy are estimated higher than the potential risk no alternative substances are existent according to research results Every such authorization is however limited in time in order to encourage research for an alternative substance. If the potentially hazardous substances are used for R&D purposes, exemptions can be granted. 6. What can REACH do if it finds a very hazardous substance whose use is very risky? REACH has the power to ban either the chemical or even the entire product containing the chemical. 7. Will all products on the market be safe in the future? No. The REACH regulation is valid only for chemical substances that are produced in or imported into the EU. It is – unless specific safety regulations apply – not valid for chemicals within a finished product. Thus, for imported products there is still no safety guarantee. 8. What are the concerns of the REACH regulation? Animal protesters fear that the REACH regulation may lead to an increase in animal testing. Economists are concerned that the regulation might hamper global trade, as there is a possibility that international companies might consider moving away from Europe to avoid red tape and additional costs related to the regulation. According to the Commission animal testing will be reduced and no economic negative implications have to be feared. 9. Is the regulation valid for all chemicals? No. Polymers, a group of chemicals which includes plastics, do not have to be registered at the moment, as there is currently no easy, cost-effective way to test them. 10. Is it possible to register chemicals online? Yes. You will be able to download a free simplified version of the International Uniform Chemical Information Database (IUCLID 5.0), which is also available as a commercial version including the ORACLE management system. Companies also have the possibility to outsource the submission through IUCLID. 11. Do I need to register preparations I want to import into the EU? Yes, if the preparation volume that you want to import equals or is bigger than 1 tonne per year. 12. What is the OSOR-principle? This means that for every single substance a registration needs to be submitted (one substance – one registration). 13. Does REACH include food or cosmetics? No, food is not an article, substance or preparation. Cosmetics were originally excluded from REACH, but in order to increase customer consumer confidence they were included afterwards. REACH is now supposed to function hand in hand with the Cosmetics Directive. 14. What are No-Longer Polymers? These are substances that were considered as polymers under the EINECS regulation, but no longer fall into this category due to a change of definition of “polymer” in the directive 92/32/EEC. These now need to be registered in accordance with REACH. Normal polymers are exempted from being registered and evaluated. However, they may still be subject to authorisation or even restriction. 15. What happens if I don’t register? Failure to register means that the substance must not be imported or manufactured within the EU. 16. What is a RIP? A RIP is REACH Implementation Project, with 11 years’ project timeline till 2018. 17. What is the difference between a phase-in and a non phase-in substance? A phase-in substance is a substance that has been listed in EINECS and/or manufactured in the EC, but never actually been placed on the market during the last 15 years. No-longer polymers are also phase-in substances. A non phase-in substance is a completely new substance that has neither been used nor registered in the market before the entry of force of REACH. Any non phase-in substance must be registered before it can be used in a manufacturing process. 18. What is a Chemical Safety Assessment? A chemical safety assessment (CSA) is a part of the registration dossier that must be prepared, if the import of a substance is bigger than 10 tonnes a year. It should list the hazards of the substances and assess their risks. The Chemical Safety Report (CSR) completes the risk assessment by stating how the risks are adequately controlled. The risk assessment needs to be performed for all different exposure scenarios, that is: for all ways in which the substance is manufactured or used, including the different ways