First SVHC Update of 2025: New Substances Added to the REACH Candidate List

First SVHC Update of 2025 New Substances Added to the REACH Candidate List

On January 21, 2025, the European Chemicals Agency (ECHA) expanded the Candidate List of Substances of Very High Concern (SVHCs) by adding five hazardous chemicals and updating one existing entry. With this update, the Candidate List now contains 247 entries, highlighting chemicals that pose potential risks to human health and the environment. The primary goal of this update is to ensure companies effectively manage the risks associated with these substances and provide essential safety information to customers and consumers. The newly added substances to the REACH SVHC Candidate List are: These substances have been added due to their hazardous properties. Two of them are classified as very persistent and very bioaccumulative (vPvB), while another two exhibit persistent, bioaccumulative, and toxic (PBT) characteristics. The reaction mass of triphenylthiophosphate and tertiary butylated phenyl derivatives, despite not being registered under REACH, has been identified as an SVHC to prevent regrettable substitution. Additionally, the existing entry for Tris(4-nonylphenyl, branched and linear) phosphite has been updated to indicate its endocrine-disrupting properties when it contains ≥ 0.1% w/w of 4-nonylphenol (branched and linear, 4-NP). Industry Impact : The newly added SVHCs are commonly used in lubricants, adhesives, sealants, and coatings. They also play a role in manufacturing cosmetics, personal care products, pharmaceuticals, electrical and electronic equipment, optical devices, machinery, and vehicles. Effects and Compliance Requirements The inclusion of these substances in the Candidate List encourages companies to seek safer alternatives. Under REACH regulations: Compliance XL offers expert consulting and training services to assist businesses in achieving REACH compliance. Our team supports companies in collecting and managing REACH declarations, ensuring that supplier certificates remain up to date and compliant with regulatory requirements. FAQs: 1. What is the one updated entry in the REACH Candidate List? The entry for Tris(4-nonylphenyl, branched and linear) phosphite has been revised to reflect its classification as an endocrine disruptor, particularly when it contains ≥ 0.1% w/w of 4-nonylphenol (branched and linear, 4-NP). 2. Which newly added SVHC has no active registrations but is still included in the list? The reaction mass of triphenylthiophosphate and tertiary butylated phenyl derivatives has been added despite having no active REACH registrations, as a precautionary measure to prevent regrettable substitution.

New Hazardous Chemical Added to ECHA’s REACH SVHC Candidate List

New Hazardous Chemical Added to ECHA's REACH SVHC Candidate List

The European Chemicals Agency (ECHA) is a key regulatory body within the European Union, responsible for managing the registration, evaluation, authorization, and restriction of chemicals. It plays a critical role in ensuring that chemicals used in the EU are safe for human health and the environment. ECHA’s work is central to the implementation of the REACH Regulation (Registration, Evaluation, Authorisation, and Restriction of Chemicals), which aims to protect human health and the environment from the risks posed by chemicals, while enhancing innovation and competitiveness in the EU. On November 7, 2024, the European Chemicals Agency (ECHA) added triphenyl phosphate to the Candidate List of Substances of Very High Concern (SVHC), increasing the total number of SVHCs from 241 to 242. This chemical is commonly used as a flame retardant and plasticizer in a variety of products, such as polymer formulations, adhesives, and sealants. Its inclusion is primarily due to its endocrine-disrupting properties, which can interfere with hormonal functions and potentially cause adverse health effects. The addition of triphenyl phosphate to the Candidate List has several significant implications: Compliance XL provides consulting services for REACH compliance and the collection of REACH declarations. We assist companies in maintaining up-to-date supplier certificates and declarations as part of a comprehensive compliance data management strategy. FAQs: 1. Why was triphenyl phosphate added to the Candidate List? Triphenyl phosphate was added due to its endocrine-disrupting properties, which can interfere with hormonal functions and present health risks. 2. What are the obligations of companies when a substance is added to the Candidate List? Companies must provide safety data sheets and instructions for the safe use of products containing the substance. They must also notify ECHA if the substance is present in concentrations exceeding 0.1% by weight. 3. What is the outlook for triphenyl phosphate? Triphenyl phosphate may eventually be moved to the Authorisation List, which would require companies to seek authorization before continuing its use.

How REACH Affects Non-EU Companies: What Exporters Need to Know

How REACH Affects Non-EU Companies_ What Exporters Need to Know

The European Union’s REACH Regulation establishes a rigorous framework to safeguard human health and the environment. For non-EU companies exporting chemical-containing products to the EU, compliance with REACH is mandatory. Failing to meet these requirements can lead to restricted market access, substantial fines, and damage to your reputation. If your business involves selling products in the EU, understanding REACH compliance is essential. This blog outlines the critical steps your company must take to successfully navigate the European market. Key REACH Requirements for Non-EU Exporters 1. Registration of Chemicals Non-EU companies are required to register any chemicals imported into the EU in quantities exceeding 1 ton per year. This involves providing the European Chemicals Agency (ECHA) with detailed information about the chemical’s properties, applications, and potential risks. 2. Appointment of an Only Representative (OR) To fulfill REACH obligations, non-EU exporters must appoint an Only Representative (OR) based in the EU. The OR acts as a liaison with ECHA, handling chemical registrations and ensuring compliance with all regulatory requirements. 3. Compliance for Imported Goods Manufacturers of finished products containing chemicals, such as electronics or clothing, must also ensure compliance with REACH. This includes registering any relevant chemicals and providing Safety Data Sheets (SDS) when required. 4. Notification of Substances of Very High Concern (SVHCs) If your products contain Substances of Very High Concern (SVHCs) in concentrations above 0.1%, you are obligated to notify ECHA and inform your customers. SVHCs include carcinogenic or toxic chemicals that pose significant risks to human health and the environment. 5. Restrictions and Authorizations Certain hazardous substances are restricted under REACH, while others may require explicit authorization for use. Exporters must ensure that their products do not contain prohibited or restricted substances unless authorized. Why Compliance is Crucial for Non-EU Companies Failure to comply with REACH can have serious consequences, including: Steps Non-EU Companies Can Take to Ensure REACH Compliance To access the EU market seamlessly and avoid compliance-related penalties, follow these steps: 1. Identify Your Chemicals Assess your products to determine the chemicals they contain. Verify whether these chemicals are registered under REACH. For unregistered substances, either complete the registration process or appoint an OR to manage it on your behalf. 2. Appoint an Only Representative Designate an OR within the EU to oversee compliance activities, including chemical registration and communication with ECHA. 3. Submit Required Declarations to ECHA Collect comprehensive data about your chemicals and submit it to ECHA for registration. This includes details on their properties, uses, and potential risks. 4. Update Safety Data Sheets (SDS) Ensure that SDS for hazardous substances are regularly updated to reflect current compliance requirements. 5. Stay Informed on REACH Updates Monitor changes to REACH regulations, particularly regarding new substances added to the SVHC list or updated restrictions. Staying informed helps maintain ongoing compliance. 6. Seek Professional Guidance Consult regulatory experts or legal professionals specializing in REACH compliance to better understand and fulfill your obligations. Adhering to REACH is essential for non-EU companies aiming to access the European market and avoid penalties. With ComplianceXL as your compliance partner, you can simplify the process by leveraging our expertise in appointing an Only Representative, registering chemicals, and ensuring all safety and labeling requirements are met. Our tailored solutions help businesses thrive in one of the world’s most regulated yet lucrative markets. Proactive compliance, supported by ComplianceXL’s services, ensures smooth market entry and sustained growth. FAQs: 1. Does REACH apply to non-EU companies? Yes, non-EU companies must register chemicals with ECHA if they intend to import more than 1 ton per year. Registration applies to both pure chemicals and substances within finished products, such as electronics, toys, and clothing. 2. Can I export products to the EU without complying with REACH? No. Non-compliant products are likely to be denied entry into the EU market. Failure to adhere to REACH can result in fines, export bans, and legal action. Only compliance ensures market access.

Six New SVHCs Proposed by ECHA : Implications for Compliance and Industry Impact

Six New SVHCs Proposed by ECHA Implications for Compliance and Industry Impact

In August 2024, the European Chemicals Agency (ECHA) launched a public consultation on a proposal to add six new substances to the Substances of Very High Concern (SVHC) Candidate List under the EU REACH Regulation. If approved, the number of entries on the Candidate List would reach 247, increasing obligations for affected industries. The consultation, published on August 30, 2024, remains open for comments until October 14, 2024. Current Status of the SVHC List: As of June 27, 2024, the REACH SVHC Candidate List contains 241 entries. Inclusion of new substances places immediate regulatory responsibilities on companies that use these substances in their products above the specified thresholds. These obligations include customer notifications and required submissions to the SCIP (Substances of Concern in Products) Database. Newly Proposed SVHCs and Their Properties: ECHA’s proposal includes six substances, flagged for their potentially hazardous characteristics, including reproductive toxicity, persistence, bioaccumulation, toxicity (PBT), very persistent, very bioaccumulative (vPvB) properties, and endocrine-disrupting effects. These substances are: The Impact of New SVHC Inclusions: If a substance is officially identified as an SVHC, it is added to the Candidate List, which serves as a stepping stone to possible inclusion on the Authorisation List. When a substance is on the Authorisation List, companies must seek authorisation from the European Commission for continued use; otherwise, its use is restricted or prohibited. Immediate Obligations for Companies: For suppliers, the addition of new SVHCs triggers several requirements: Benefits of Compliance: Identifying and addressing SVHCs helps companies proactively manage potential risks associated with hazardous substances, aligning with EU’s stringent environmental and public health standards. Proactive compliance not only supports legal requirements but also bolsters customer trust and brand reputation, as consumers increasingly prioritize sustainable, safe products. Compliance XL provides comprehensive consulting services for REACH compliance, including support with REACH declarations and SVHC data management. Our services include maintaining supplier certificates and declarations to ensure up-to-date compliance records, simplifying the ongoing obligations companies face as they adapt to regulatory updates. As the regulatory landscape evolves, understanding and adhering to REACH requirements is essential. Compliance XL is committed to helping companies stay ahead of regulatory changes, ensuring smooth operations and compliance. Reach out to learn how we can assist with your REACH compliance strategy and data management needs. FAQs: 1.Who needs to comply with REACH?  Companies or individuals that import, manufacture, use or place substances, mixtures or articles on the EU market must be compliant with the REACH regulation. 2.How can companies ensure compliance with REACH?  Companies can ensure compliance by registering their substances with ECHA, maintaining up to date SDS, keeping detailed records, and staying informed about regulatory changes.

REACH SVHC Candidate List: Newly Added Substances and Their Significance

REACH SVHC Candidate List Newly Added Substances and Their Significance

The European Chemicals Agency (ECHA) has added five new hazardous chemicals in its 30th update of the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) Candidate List, bringing the total to 240 SVHC entries. This underscores the importance of effectively managing the risks associated with these substances and underscores the commitment to enhancing chemical safety. The European Chemicals Agency (ECHA) added five new substances to the REACH SVHC Candidate List on 23rd Jan 2024. The ECHA has also updated the existing Candidate List entry for dibutyl phthalate to include its endocrine-disrupting properties for the environment. Five chemicals are added to the candidate list based on the level of their toxicity. One of them is reprotoxic, three are very persistent and very bio accumulative and one is toxic for reproduction and persistent, bio accumulative, and toxic. Newly added chemicals are commonly used in coating products, adhesives, and sealants, and washing and cleaning products. Newly added substances may be placed on the Authorisation List in the future. If a substance is part of the Authorisation list, its use will be prohibited if companies do not apply for authorization and the European Commission authorizes them to continue its use. Suppliers of articles containing an SVHC above a concentration of 0.1 % (weight by weight) must inform their customers and consumers how to use them safely and have to provide a safety data sheet. Importers and manufacturers of articles should notify ECHA if their article contains a Candidate List substance within six months from the inclusion date. Compliance XL provides consulting services to companies in the field of REACH compliance and the collection of REACH declarations. We also help customers regularly maintain their supplier certificates and declarations to ensure they are up to date as part of their compliance data management strategy. FAQs: 1.What is the REACH limit for SVHC? Article 33(1) of the REACH Regulation states that manufacturers and importers of articles (products) are required to notify their customers of the presence of any Substances of Very High Concern (SVHC) in their products exceeding 0.1% by weight and provide instructions on safe use of the product. 2.What type of chemicals are considered under REACH SVHC candidate list? Chemicals that are Carcinogenic, mutagenic or reprotoxic (CMR) category 1 or 2, persistent, bio-accumulative and toxic (PBT) substances, very persistent and very bio-accumulative (vPvB) substances, substances for which there is evidence for similar concern, such as endocrine disruptors.

Anticipated Expansion of REACH SVHC List to Reach 240 Substances

Anticipated Expansion of REACH SVHC List to Reach 240 Substances

Keeping up with the most recent developments is crucial when it comes to chemical safety and regulatory compliance. REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) Candidate List 30th update started by the European Chemicals Agency (ECHA) lately. Within the European Union’s chemical regulation framework, the REACH Candidate List is an essential tool. It performs the function of a dynamic inventory of compounds that could be harmful to the environment or human health. For producers, importers, and other chemical industry players, being on this list is essential since it serves as a basis for future licensing and restriction measures. The ECHA has proposed five compounds for consideration as SVHCs in this most recent update. After a careful evaluation, it was determined that these compounds have characteristics that could have negative effects. One proposal also seeks to update a previously listed substance’s SVHC property. Let’s examine these compounds in more detail: Dibutyl Phthalate (DBP) Dibutyl phthalate, or DBP, has been the subject of long-term investigation. DBP has once again come under regulatory scrutiny after being classified as an SVHC in 2008 due to its harmful effects on reproduction. The European Commission (EC) acted decisively in 2017 by admitting that it has endocrine-disrupting effects on human health. It is now suggested that its endocrine-disrupting qualities be acknowledged regarding the environment, hence increasing its classification as an SVHC. Other Proposed SVHCs Although DBP is the focus, it’s important to pay attention to the other substances that have been suggested in this update. Every one of these compounds has potential uses as well as a unique set of worries. We’ve put up the following table to provide you a clear summary: Substance name CAS number (EC Number) Reason for proposing Potential application 2,4.6-tri-tert-buty1phenol (2.4,6-TTBP) 732-26-3 (211-989-5) Toxic for reproduction (Article 570; PBT (Article 57d); vPvB (Article 57e) Used in industrial formulation of fuel additives and fuel blends; Used as inter- mediate 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl) phenol 3147-75-9 (221-573-5 vPvB (Article S7e) Used in air care products, coating products. adhesives and sealants, lubricants and greases, polishes and waxes and washing & cleaning products. 1-Butanone, 2-(dimethylamino)-2-[(4-methylphenyl) methyl]-1-[4-(4-morpholinyl) phenyl]- 119344-86-4 (438-340-0) Toxic for reproduction (Article 57c) Used as photo initiator in IJV-inks; Used as intermediate- Used in industrial application of coatings and inks- Burnetrizole 3896-11 -5 (223-445-4) vPvB (Article 57e) • Used in coatings, adhesives, sealants, printing inks, polishes and wax blends, textile dyes, finishing and impregnation products: • Used in washing and cleaning products, fillers, putties, plasters, modelling Clay, cosmetics, fragrances, air care products, biocidal products, pho- to-chemicals, and metal and non-metal surface treatment- Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol (OAPP) 68512-30-1(700-960-7) vPvB (Article 57e) Used in adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, inks and toners and polymers. Dibutyl phthalate (DBP) 84-74-2 (201-557-4) Toxic for reproduction (Article 57c); Endocrine disrupting properties (Article S7(f) – human health), Endocrine disrupting properties (Article 57(f) – environment) Used as plasticizer for PVC, synthetic leather. It can be found in plastisol, and flock printing For stakeholders in a range of industries, including toys, children’s items, hardlines, soft lines, electrical and electronics, and more, the possible addition of these compounds to the REACH Candidate List has substantial ramifications. Those who may be impacted must keep up with these changes to guarantee compliance and control any possible dangers related to these compounds. The projected SVHCs’ future is in jeopardy while the public consultation continues. In December 2023 or January 2024, there will be 240 SVHCs overall included on the Candidate List if the Member State Committee manages to come to a unanimous decision. This update reaffirms the European Union’s dedication to improving chemical safety and guaranteeing environmental and public health protection. To aid businesses in adeptly navigating the regulatory landscape associated with these planned restrictions, ComplianceXL offers comprehensive compliance management services. Our tailored solutions streamline compliance management, facilitate risk assessments, and deliver accurate reports on schedule. Leveraging two decades of extensive knowledge in the field, ComplianceXL ensures that companies are well-prepared to tackle the challenges posed by the ever-evolving regulatory environment.

Deciphering REACH: Annex 14, Annex 17, and SVHC Distinctions

To oversee and manage the utilization of chemicals in the European Union (EU), the EU established the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) legislation. Enacted on June 1, 2007, REACH aims to ensure a high standard of protection for both the environment and public health while simultaneously enhancing the competitiveness of the European chemicals sector. In our exploration of “Meeting REACH requirements,” we identified three pivotal lists that EU manufacturers must be mindful of to ensure comprehensive compliance: 1. Substances of Very High Concern (SVHC): Chemicals with potential hazards to the environment or human health are listed on the SVHC or Candidate Lists. These substances undergo further scrutiny and may end up on the Authorization List. Manufacturers, importers, and downstream users have specific obligations if a substance is included on the Candidate List. If an SVHC is present in their product at a concentration exceeding 0.1% by weight, they must report it to the European Chemicals Agency (ECHA). The purpose of this list is to monitor and prioritize compounds for future evaluation and regulation. The SVHC list is revised biannually, necessitating businesses to reassess product compliance and request data from suppliers to meet REACH standards. 2.The Authorization List (Annex XIV): Annex XIV of REACH, known as the Authorization List, comprises substances of very high concern (SVHC) posing serious risks to the environment or human health. Unless a specific exemption applies, companies using substances listed on the Authorization List must obtain authorization from ECHA before their use. The primary goal of the Authorization List is to phase out or restrict the use of hazardous substances gradually while promoting safer alternatives. 3.The Restriction List (Annex XVII): The Restriction List, or Annex XVII of REACH, imposes specific restrictions on the production, marketing, or use of hazardous chemicals. These legally binding restrictions aim to mitigate risks associated with substances, products, or processes. Restrictions may take the form of usage prohibitions, concentration thresholds, or other controls. In summary, the REACH legislation assigns distinct responsibilities to these lists: Substances of very high concern are identified on the Candidate List, triggering additional scrutiny. The use of chemicals listed on the Authorization List requires specific authorization. The use of certain hazardous substances is legally restricted according to the Restriction List. These lists collectively govern the use of chemicals in the EU, ensuring that businesses dealing with these substances adhere to relevant REACH requirements and regulations. With over 20 years of regulatory experience, ComplianceXL provides ongoing assistance to companies seeking compliance with REACH regulations, facilitating efficient risk assessments, compliance management, and accurate reporting for improved regulatory operations.

ECHA proposes to add 9 new chemicals as SVHC

Change is in the air again with ECHA proposing to add nine more substances to SVHC, if approved the number of SVHC will increase from 224 to 233. The European Chemicals Agency (ECHA) launched the public consultation for the 28th update of the REACH Candidate List on 2 September 2022. The public consultation will end on 17 October 2022. Based on the previous public consultation, the following criteria are used to identify and propose SVHCs: Carcenogenic, Mutagenic or toxic to Reproduction (CMR) category 1 or 2 as per the directive Directive 67/548/EEC Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) as per Annex XIII of REACH Any substance evaluated causing serious effects to human health or environment Below are the substance details and its applications: Substance Name: 4,4′-sulphonyldiphenol (bisphenol S; BPS)CAS number: 80-09-1Reason for proposal: Toxic for reproduction (Article 57c); Endocrine disrupting properties (Article 57(f) – environment); Endocrine disrupting properties (Article 57(f) – human health)Used in: Manufacture of pulp, textile, leather or fur, paper products etc. Substance Name: Perfluoroheptanoic acid and its saltsCAS number: Group compounds hence not applicableReason for proposal: Toxic for reproduction (Article 57c); PBT (Article 57d); vPvB (Article 57e); Equivalent level of concern having probable serious effects to human health (Article 57(f) – human health); Equivalent level of concern having probable serious effects to the environment (Article 57(f) – environment)Used in: stain-resistant fabrics, paper food packaging, and carpets Substance Name: MelamineCAS number: 108-78-1Reason for proposal: Equivalent level of concern having probable serious effects to human health (Article 57(f) – human health); Equivalent level of concern having probable serious effects to the environment (Article 57(f) – environment)Used in: polymers and resins, Coating products, Adhesives and sealants, lab chemicals Substance Name: 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]CAS number: 37853-59-1Reason for proposal: vPvB (Article 57e)Used in: used as a flame retardant for many thermoplastic. Substance Name: 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenolCAS number: 79-94-7Reason for proposal: Carcinogenic (Article 57a)Used in: reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards and paper and textiles. Substance Name: Barium diboron tetraoxideCAS number: 13701-59-2Reason for proposal: Toxic for reproduction (Article 57c)Used in: paints and coatings Substance Name: Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereofCAS number: Group of compounds hence not applicableReason for proposal: vPvB (Article 57e)Used in: flame retardant, plasticizer for flexible polyvinylchloride, wire and cable insulation, carpet backing, coated fabrics etc. Substance Name: Isobutyl 4-hydroxybenzoateCAS number: 4247-02-3Reason for proposal: Endocrine disrupting properties (Article 57(f) – human health)Used in: coating products, fillers, putties, plasters, modelling clay, inks and toners etc. Substance Name: 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) morpholineCAS number: Group of compounds hence not applicableReason for proposal: vPvB (Article 57e)Used in: in formulation or re-packing at industrial sites and in manufacturing etc. Timelines: The deadline for comments from all affected/concerned parties is 17 October 2022. Interested in learning more about the upcoming REACH update and its impact on various industries? Talk to one of our compliance specialists at ComplianceXL.

ECHA adds a new substance to REACH SVHC

On 10th June, 2022, The European Chemicals Agency (ECHA) has added one more substance to its list of SVHC candidates, which was updated from 223 to 224. The newly added substance to candidate list is N-(hydroxymethyl)acrylamide (CAS-924-42-5) which is mainly a carcinogen as well as Mutagen. N-(hydroxymethyl)acrylamide is generally found as intermediate compound in thermoplastic manufacturing. Also, N-(hydroxymethyl)acrylamide is classified as TOXIC LIQUID, ORGANIC, N.O.S. (N-(Hydroxymethyl)acrylamide, acrylamide, formaldehyde) with UN 2810 and dangerous for transportation by road, rail and air. As a result of substance additions to the EU REACH SVHC List, if the substances are used in products above an agreed threshold, affected companies are subject to immediate obligations. ECHA must also be informed through submissions to the SCIP Database, which include notifying customers. In addition, this obligates supply chains to contact all their immediate suppliers to identify the risks due to N-(hydroxymethyl)acrylamide. We at ComplianceXL help organizations coordinate this process from start to finish, including coverage for the SCIP Database. We do this by supplier engagement, data collection, data validation, substance calculations, and report generation as part of our EU REACH compliance documentation services. Get in touch with us today if you would like to know more about what our company can do for you regarding EU REACH compliance needs.

Turkey REACH and its Implications

Turkey REACH law is like EU REACH and requires the companies to pre-register (by 31 Dec 2020) and register (31 Dec 2023) substances (on their own, in mixtures or in articles) manufactured in Turkey or imported into Turkey with volumes equal to or above 1 ton per year. This is called as KKDIK. KKDIK stands for Turkish for Registration, Evaluation, Authorization and Restriction of Chemicals. Only one representative (OR) can be appointed by companies to submit KKDIK registration and CLP notification on their behalf. There are no separate deadlines set depending on the classification of the substance or the annual tonnage band, for pre-registration and registration. Submissions for Pre-MBDF will be accepted after 31 Dec 2020 All registrations must be completed between 31 Dec 2020 – 31 Dec 2023 After 31st Dec 2023,substances that are equal to or above one ton per annum, cannot be place or manufactured in Turkish market, If they are not registered as per KKDIK provisions. KKDIK came into force on 23rd Dec 2017 and replace below 3 regulations in Turkey. The Inventory and Control of Chemical Regulation (KEK) – Effective from 23, Jun 2017 Regulation on Restrictions for the Manufacture, Marketing and Use of certain Dangerous Substances and preparation – Effective from 23 December, 2017. Regulation on Safety Data Sheets for Hazardous Substances and Mixtures (GBF)- Effective from 31 December, 2023. Below are the main obligations that is under KKIDK: Notification on MBDF- Deadline is 31 Dec 2020 Registration – Deadline is 31 Dec 2023 Authorization – Date/substance in Annex XIV determined by the MoEU (Turkish Ministry of Environment and Urbanization) Restriction – Dates Annex XVII (Article 66 of KKDIK regulation) Below substances and Mixtures are not covered by KKDIK: Radioactive substances Goods in free-zone for re-export Non-isolated intermediates Transport of dangerous substances and mixtures by various modes Substances manufactured or imported for defense purpose Medicinal products Cosmetic products Veterinary products Food and feeds Medical devices Active substances and co-formulants that are only manufactured or imported for using in plant protection products need to be registered under Turkey REACH. Active substances approved for biocidal products also need to be registered. GHS safety data sheet and labelling are still needed for the plant protection products and biocidal products, that are exempt from KKDIK. Candidate list for Turkey REACH is same as that of EU candidate list. The main key difference between EU REACH and Turkey REACH is that, KKDIK, requires only trained and qualified experts sign off and registrations and notifications. There are no other major differences between EU REACH and Turkey REACH.

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