Hazard Classification of Glyphosate by EFSA and ECHA
A record number of comments were received during EFSA and ECHA’s consultations on the draft assessments of glyphosate, indicating that it is a highly relevant substance. The level of public participation in the evaluation of active substances in the EU highlights the importance of transparency. As of 10 May 2022, EFSA added significant new data to a dossier containing far more scientific evidence than are normally available for such assessments with the input received from the consultations and responses received from the applicant (the Group on the Renewal of Glyphosate) in response to the agency’s request for additional information. The Assessment Group on Glyphosate (AGG), composed of four EU Member States – France, Hungary, the Netherlands and Sweden – that is currently updating its initial draft renewal assessment report (dRAR), will thoroughly review the additional information. To accommodate this context, EFSA and ECHA revised the timeline for the remaining steps in the process of re-evaluation. ECHA’s classification As part of its plenary meeting on 30-31 May, the ECHA’s Committee for Risk Assessment (RAC) is scheduled to discuss the hazards of glyphosate. As part of its review, the Committee will examine carcinogenicity, genotoxicity, reproductive and developmental toxicity, as well as environmental classification. A draft of RAC’s opinion will be made available to EFSA and published on ECHA’s website within 8-10 weeks (i.e., mid-July to the end of August 2022). As part of the peer review of the dRAR, the EFSA will take into account the RAC opinion. EFSA’s peer review The EFSA received 368 responses to its public consultation, many of which included multiple comments. Additionally, EFSA received approximately 2400 comments from Member State experts and the Glyphosate Renewal Group (GRG). The GRG and the AGG will need to review approximately 3000 pages of these contributions, which will serve as the basis for developing an updated dRAR. As per AGG’s notification to EFSA, the updated dRAR is scheduled for submission on 30 September 2022. The Pesticides Peer Review meetings will therefore be held between November and December 2022 at EFSA, and the conclusions will be finalized by July 2023. EFSA will evaluate all possible risks associated with glyphosate exposure, including those to humans, animals, and the environment. In addition to considering all comments, this updated timeline reflects our obligation to conduct a thorough risk assessment. Timeline: Glyphosate re-assessments December 2019: The Glyphosate Renewal Group (GRG) submits a renewal application. June 2020: The Glyphosate Review Group submits a complete renewal dossier, and the Assessment Group on Glyphosate (AGG) begins working on the initial assessments. June 2021: The AGG submits the draft renewal assessment report (dRAR) and the Harmonised Classification and Labelling (CLH) report to EFSA and ECHA, respectively. August 2021: AGG updates dRAR and CLH reports for EFSA and ECHA based on qualitative and administrative checks. September 2021: EFSA and ECHA launch parallel consultations. November 2021: The parallel consultations close. First half of 2022: In addition, AGG takes into account the GRG’s response to each of the comments received during the consultations. EFSA and ECHA review the comments and the information received during the consultations, including the AGG considerations. EFSA requests additional information from GRG to complete the data package and sends agreed action points for AGG to follow up on 21/22 April 2022: The ECHA’s Committee for Risk Assessment (RAC) Working Group discusses the proposal for harmonized classification and labelling (CLH). 30 May – 3 June 2022: ECHA’s RAC will meet, and an opinion will be adopted on glyphosate’s classification. End of September 2022: EFSA will receive an updated dRAR from the GRG following the identification of action points and the evaluation of additional information provided by the GRG. November – December 2022: Experts from EFSA and EU Member States will meet to peer review the updated renewal assessment report (RAR). The AGG shall then review the RAR in light of the expert meeting outcomes and, subsequently, EFSA shall draft the peer review Conclusions in conjunction with follow-up consultations with AGG and Member States experts. July 2023: The European Commission, member states, and the GRG will receive the conclusions of EFSA’s peer review.
Consultations Launched for Applications for Authorization
The European Chemicals Agency (ECHA) is seeking comments on 13 applications covering 17 uses of the following: chromium trioxide (EC 215-607-8, CAS 1333-82-0): It is used to functional chrome plate, anodize aluminum spars or electroplate shock absorber rods, coat substrates with chrome, etch and electroplate substrates. In addition to its industrial applications, this chemical is also used in the hard chromium coating of complex outer surfaces of firearm auxiliary parts subject to mechanical, chemical, and thermal stress for great heat, corrosion, wear, and barrier properties, plus the ability to withstand hot combustion gas erosion after post-processing. The plating of dental instruments used by professionals for dental treatment; plating small components with simple geometries that don’t require special approval procedures for their use in demanding sectors like food, paper, and chemical production. It is an electroplating process for different kinds of substrates that are designed to produce a bright, long-lasting, durable (shiny) or matte surface (functional electroplating with decorative characteristics). 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated (EC -, CAS-): used as a detergent in the purification of lapidated OspA protein subsequently used for manufacturing of a lyme disease vaccine candidate; 4-nonylphenol, branched and linear, ethoxylated (EC 500-209-1, CAS 68412-54-4): Mixing by the Applicant of an NPnEO-containing epoxy resin used for the manufacture of glass fibre articles for critical composite helicopter parts, that is exempt from authorization under REACH Art. 56(6)(a) More information about the uses that authorization is applied for, including the description of the function of the substance, exposure scenarios, possible alternatives identified by the applicants, together with socio-economic information, is available on the ECHA website. The deadline is 6 April 2022.
ECHA Postpones Submission Data for Bisphenol a Restriction Report
According to ECHA, the submission of the 4,4′-isopropylidenediphenol (bisphenol A, BPA) (EC 201-245-8,CAS 80-05-7) restriction report by Germany has been postponed until 7 October 2022. European Chemicals Agency (ECHA) is seeking comments on the substance and examples of its uses: N-(Hydroxymethyl)acrylamide (EC 213-103-2, CAS 924-42-5) used as monomer for polymerization.The chemical Bisphenol A (BPA) is used to make polycarbonate plastic. In addition to hard plastic items, such as baby bottles, re-usable water bottles, food containers, pitchers, tableware, and other storage containers, polycarbonate plastic is also used to make soft plastic items. BPA may have adverse effects on the fetus, infant, and child’s brain and prostate gland when exposed to it. Children’s behavior may also be affected by BPA exposure. In addition, additional research indicates that BPA may be related to increased blood pressure, type 2 diabetes, and heart disease. The deadline for comments on BPA restriction is 19 April 2022. Until the outcome of the Annex XV review and any restrictions proposed, ECHA keeps a registry of restriction intentions. A restriction proposal can be prepared by a Member State or by ECHA either on their own initiative or at the request of the Commission. An authorization request can be made for substances on the Authorization List. A Member State must inform ECHA of its intention to develop a restriction dossier as a matter of law. Interested parties can plan and prepare their comments in advance by reviewing the advance notice. Following the progress of a proposal through the restriction process is possible, starting with the notification of the intention, followed by the adoption of the final opinions by the Risk Assessment Committee (RAC), the Socioeconomic Analysis Committee (SEAC), and the adoption by the European Commission of the restriction. As part of the preparation and consultation of the restriction proposal, stakeholders are encouraged to submit any relevant information to the dossier submitters. It is important to receive information to motivate any exemptions to the scope described in the intention during the preparation phase of the dossier. Companies are responsible for making sure they are aware of the composition of the products they sell. Using ComplianceXL’s Managed Compliance Solution, you’ll enhance data collection and streamline reporting for chemical substances using regularly updated restricted substances lists.
All you need to know about CoRAP by ECHA
CoRAP (Community Rolling Action Plan) prioritizes Substances for evaluation for a period of three years. Substances that require an immediate evaluation are listed in first year of the plan. Member states will evaluate the risk of substance listed CoRAP. ECHA updates the plan every March in order to advance planning for the coming year and add new substances. The plan can include the revision of already listed substance. When a member state has information suggesting a substance is priority for evaluation, they can notify the substance at any time for inclusion. A risk based criteria is used by ECHA and Member states for the selection of substances for the CoRAP. The selection criteria covers hazard information (Substance fall under – PBT, Endocrine disruption or CMR), exposure information and total registered volumes. CoRAP will check if the listed substance has any serious risk to Human health or environment. The evaluation might end up in either of the two ways: The risk is under control with the existing measures, need not require any additional measures. If the Member state conclude that the substance has a risk, then below options are addressed, Harmonized classification and labelling for carcinogenic, mutagenic or reproductive toxicity, respiratory sensitiser or other effects To identify as the substance of very high concern. To restrict the substance Actions outside the scope of REACH such as a proposal for EU-wide occupational exposure limits, CoRAP process uses all the dossiers registered by the registrants. As on 1st of Sep 2021, new substance evaluation conclusions are published for below 3 chemicals: Silicon Dioxide – CAS 7631-86-9. This was added to CoRAP list in 2012 and was evaluated by Netherlands. This is used as a repellent in plant protection products. Conclusions made: The substance has concluded for Harmonized Classification and Labelling, Need for follow-up regulatory action at EU level and Other EU-wide measures. Dichloromethane -CAS 75-09-2. This is added to CoRAP list in 2016 and evaluated by Italy. Dichloromethane is a restricted substance in the Annex XVII of the REACH Regulation (Entry 59). Conclusions made: This has been concluded as Need for follow-up regulatory action at EU level and Harmonized Classification and Labelling Bis(2-ethylhexyl) adipate – CAS 103-23-1. This was added to CoRAP list in 2020 and evaluated by Finland. Conclusions made: This has been concluded as Need for follow-up regulatory action at EU level and Harmonized Classification and Labelling
ECHA publishes SCIP data
ECHA has released the first public database of SCIP, which contains the results of testing on substances of very high concern. The SCIP database is a comprehensive and systematic compilation of chemical information on substances including potential adverse effects. This SCIP database allows consumers to be informed about their products and facilitates recycling and reusing of them. The EU’s new SCIP database available to the public will help in the development and use of safer chemicals, and in identifying alternatives to hazardous substances for which there is no appropriate alternative. There are around 6000 companies that have successfully comply with notifying SVHCs (Substance of high concern) in SCIP. There are more than four million article notifications in the database. It includes details on when restrictions were imposed, how they can be used safely if they are not banned, their potential risks and examples of where they have been subject to restrictions elsewhere in the world. This will help authorities in member states identify potentially harmful substances more quickly when new ones are brought onto their markets. Based on the information available; below are the common product categories that are notified. Furniture Vehicle and parts of vehicle Measuring instruments Electronic equipment Machinery and its parts Rubber products/article Below are the most common substances that are notified by the companies: Dechlorane Plus, found in paints and Glue Lead Monoxide, found in Vehicle parts, lamps Lead, found in batteries and Ball bearings Lead titanium trioxide found in electronic items Silicid acid or lead salt found in Vehicle coatings and leaded crystalware The data can be searched by Product category, chemical name, type of category, brand or article name. This data will help the consumers in buying products of their choice by understanding any hazardous substance in the product. Waste operators utilize the data to enhance the reuse of products.
Did you know? ECHA has identified 300 chemicals as candidates for regulatory action
On 21 April 2021, ECHA published its third report on Integrated Regulatory Strategy. It provides latest information on Agency’s work regarding the identification and management of chemicals that are hazardous. It aims at accelerating data generation, identifying of groups of substances of concern, and regulatory action. Last year, ECHA addressed the chemical with similar structure in groups instead of each chemical individually. This increased the total number of chemicals assessed in 2020 to 1900.As per the report, RMOA (Regulatory management option analysis) it was concluded that 290 substances were identified for further regulatory risk management. These chemicals require more data to be submitted and hazard confirmation before taking any regulatory action. These substances include potential CMRs, few potential EDs, PBTs and respiratory sensitizers. The conclusion will be shared and publicly available on ECHA’s website by end of 2021. Under EU legislation, harmonized classification is a prerequisite for risk management actions. Over 100 chemicals identified would warrant harmonized classification, but still not picked up by the authorities. Lack of harmonized classification can cause a delay in risk management action by the authorities, The progress is made in clarifying the need for regulatory action of substances registered above 1 ton. ECHA recommend that, while the agency continue to work on optimizing group approach for substances: Member states, without delay should initiate regulatory risk management for the substances that require further action. Member states should collaborate with each other to maximize their outcome of work. Industries should make use of the developed programs to help them to review and update the REACH Dossiers. Updates must be done proactively, even before authorities take regulatory actions. ECHA aims to provide clarification by 2027 for which registered substances are a high priority for regulatory risk management or data generation, and which are currently a low priority for further regulatory action. Talk to one of our global compliance specialist today!
ECHA working to make Drinking water safe
On 10 th Jan 2020, ECHA announced that they are working on developing a positive list of substances that can be safely used in materials that come into contact with drinking water. It will improve consumer protection and ensure equal safety standards for the industry. The first positive list containing around 1500 chemicals, is expected to be adopted by the EuropeanCommission by 2024. This list is based on the existing list in the member states. ECHA will reassess,prioritise, review the list and will recommend expiry dates for them. This will be based on thehazardous properties and as well as the quality of the substance. This important consideration in the regulation comes to improve the quality and supply of drinking water and also the confidence in tap water. With this regulation, ECHA wants to ensure that only safe substances can be used in pipes and taps in contact with water. This will minimise the harmful effects of pollution on both human health and natural resources, in line with the European Green Deal. The introduction of this full risk-based approach would improve coherence with the Water Framework Directive and helps to identify potential contamination sources, to reduce risks and therefore to better focus treatment and monitoring efforts. The implementation will be carried out in collaboration with the European Food Safety Authority (EFSA) since water is closely related to food contact materials. The regulation is expected to tackle emerging pollutants such as microplastics, endocrine disruptors as well as new types of chemicals (PFAs). If any of the companies want to keep their substance in the positive list, they need to submit a review application to ECHA. They can also apply if they want to add new substances to the list. Are you affected by this upcoming regulation? Talk to one of our ECHA Compliance Experts to learn more and do an assessment.
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
ECHA Proposes To Restrict Intentionally Added Microplastics
ECHA (European Chemicals Agency) has submitted a proposal for a new regulation to restrict microplastic particles that have been added intentionally in consumer and commercial products. What are microplastics? Microplastics are tiny particles of plastic material, typically smaller than 5 mm including much smaller nano-plastics. They are deliberately manufactured and intentionally added to products for certain specific reasons and used in a variety of consumer, agricultural, professional, and industrial products such as: Cosmetics and personal care products – both rinse-off and leave-on products Detergents and cleaning products – encapsulation of fragrances in laundry detergents and cleaning products paints, inks and coatings Products used in the oil and gas industry abrasive blasting media Agricultural and horticultural products – fertilizers and plant protection products Apart from this, some products are designed to intentionally release microplastics as a part of their function; for example, products such as nutrient pills used in the agricultural sector. These microplastic particles accumulate in the environment and may get consumed by animals and fish, which eventually be eaten consumed by human beings, which can be hazardous. What has been done in the EU? Many EU states have either banned the intentional use of such microplastics or have proposed bans. The biggest concern with the impact of products is they adversely affect human health and the overall environment. Some of the consumer products that use ‘microbeads’ in ‘rinse-off’ cosmetics, which act as exfoliating and cleansing agents are expected to be banned. What is ECHA’s assessment? Intentionally added microplastics are likely to get accumulated in terrestrial and aquatic environments. The alarming factor is that the bio-accumulation of these microplastics is rather persistent and lasts for thousands of years and becomes practically impossible to remove. At present, it is nearly impossible to measure the long-term exposure of these microplastics and their impact on the environment. Limited availability of data The risk assessment of microplastics on the environment is highly challenging due to the inadequate availability of information on the after-effects. The food chain becomes more vulnerable to the negative effects of microplastics because of its size and their degradation will result in much smaller particles, which makes it very difficult to identify or control. The socio-economic impact of such restrictions ECHA has identified that the agricultural sector will be the most affected industry segment, and the restrictions are likely to result in a difference in the cost of the product. However, ECHA expects the entire activity to be cost-effective in all sectors in the long run, by using environmentally friendly alternatives at better costs. Labeling requirements In addition to the ban of microplastics, the new regulations also require manufacturers to provide warnings through labels about potential microplastics released during usage. Some of the products affected by this requirement include: Paints, inks, and coatings – both for professional and consumer applications Chemicals – esp. oil and gas processes Construction products – cement and adhesives Medicinal products and medical devices What does the restriction proposal not cover? At the outset, few of the naturally occurring polymers such as cellulose, polymers that meet the proposed interim biodegradability criteria, or fertilizing products, are not included. However, the upcoming Fertilizing Products Regulation will keep a check on such products. How would the restriction work? The regulation is expected to be effective starting in 2021, in a phased manner to give manufacturers enough time to redevelop, rediscover and find suitable environmental friendly alternatives to microplastics. By this regulation, the release of microplastics is estimated to reduce by 400,000 tons over 20 years. What do you need to do? With the enforcement of various environmental regulations, manufacturers have to be more cautious and remain up-to-date, to stay compliant. Ensuing compliance requires extensive efforts in understanding complete regulations, compliance documentation requirements, supplier engagement, finding alternatives and accurate compliance reporting. Are you affected by this upcoming restriction? Talk to one of our Compliance Experts to learn more and do an assessment.