GPC Newsletter May-2023

On 14 March 2023, the US EPA has come up with its new long-awaited drinking water standards to prevent water from Per- and poly fluroalkyl substances (PFAS) contamination. The new rule sets maximum contamination levels (MCLs) for six PFASs to safeguard public health. It would enforce separate standards for the almost disused PFOA and PFOS, as well as a combined limit for PFNA, PFHxS, PFBS and GenX.

In the current version of the proposed standard, MCLs separately regulate PFOA and PFOS at 4 part per trillion (ppt)  which is realistic based on existing quantification and water treatment techniques. As a part of the proposal, mixtures of any of the four compounds to a hazard index of 1.0 which would indicate whether the combined amounts could pose a risk.

Water systems would need to be monitored for all six pollutants under the Safe Drinking Water Act (SDWA) regulation. Utility companies would have to inform the public and treat the water if levels were to surpass the limitations.

On 15 May 2023, the European Commission adopted the 12th revision of The SCCS Notes of Guidance for the testing of Cosmetic Ingredients and their Safety Evaluation. The SCCS Notes of Guidance (NoG) are revised and updates by the European Commission’s Scientific Committee on Consumer Safety (SCCS) approximately every 3 years, to incorporate the progress in the field of testing and safety evaluation of cosmetic ingredients. The NoG aim to provide guidance to public authorities and the cosmetic industry in order to improve harmonised compliance with the current cosmetic EU legislation (Regulation (EC) No. 1223/2009). The notes contain information on the different aspects of testing and safety evaluation of cosmetic substances with the emphasis on cosmetic ingredients, although some guidance is also indirectly given for the safety assessment of finished products.

The updates in the 12th revision of the Notes of Guidance have emphasis on the following aspects:

• Importance of systematic literature review

• Updating of animal-free alternative methods: NAM (New Approach Methodology), changes introduced for acute inhalation, skin irritation testing, eye irritation testing with DAL (Defined Approach for eye irritation, Liquid), DASS (Defined Approaches for Skin Sensitisation), new in vitro methods for genotoxicity testing (3D skin Comet; in vitro micronucleus)

• Importance of AOP (Adverse Outcome Pathway), DAs (Defined Approaches), IATA (Integrated Approaches to Testing and Assessment), NGRA (Next Generation Risk Assessment) with definition of BER (Bioactivity/Exposure Ratio), TTC (Threshold of Toxicological Concern), iTTC (internal TTC)

• Updating of in silico prediction possibilities

• Exposure data reviewed (models, parameters specific for inhalation, aggregate exposure)

• Exposure of children to different cosmetic product categories according to age

• Sun protection by sunscreen products: rationale behind exposure data

• Human biomonitoring (HBM) and differences with SCCS approach for risk assessment

• Reporting requirements for cancerogenic, mutagenic and reprotoxic substances (CMRs)

• Introduction of non-monotonic dose response, reporting requirements for endocrine active substances

• Templates for PBTK (Physiologically Based ToxicoKinetic) model description and parameter verification and analysis

The full text of the NoG can be found here: https://health.ec.europa.eu/system/files/2023-05/sccs_o_273.pdf

The "Chemicals in Plastics: A Technical Report" released by the UN on 3 May 2023, attempts to educate the world's population on the frequently disregarded chemical-related problems associated with plastic pollution, including their detrimental effects on human health and the environment, resource efficiency, and circularity.  It further emphasises the urgent need for action and provides potential areas for action based on convincing scientific evidence.  Additionally, it aims to aid in the development of the plastic pollution instrument based on resolution 5/14 of the United Nations Environment Assembly. Several reliable and openly accessible research studies and projects pertaining to chemicals in plastics and the intersection of science and policy are described in the report. 

According to the report, more than 13,000 chemicals have been linked to plastics and plastic manufacture in the most recent studies, out of these more than 3,200 plastic monomers, additives, processing aids, and non-intentionally added substances (NIAS) have been identified as chemicals of potential concern based on their hazardous qualities and 7,000 compounds have been evaluated for their hazardous properties.    

The following table lists priority industries, along with a list of the chemicals that should be of particular concern: 

Chemicals in plastics: Exposure of the ecosystem and people 

Plastics in the environment deteriorate and fragment into smaller pieces to generate microplastics and nanoplastics as a result of exposure to sunshine, wind, and waves. Other processes that can break down plastics include biodegradation, photodegradation, thermal degradation, and hydrolysis. In contrast to underground, underwater (such as in the deep sea), or in non-surface polar conditions where UV radiation and mechanical erosion are negligible, plastics are more prone to deteriorate on surface soil, surface water, or in the air. Plastics are very persistent in the environment, though, as the bulk of them are produced from non-biodegradable polymers and contain additives like UV stabilisers, antioxidants, and heat stabilisers that are meant to keep them durable. 

Chemicals linked to plastic are particularly dangerous to women and children. Exposures can negatively affect a woman during numerous important stages of her life and even affect future generations. For instance, exposures during foetal development and in children can result in problems related to neurodevelopment and neurobehavioral processes. Men are not exempt either, as recent studies show that significant negative impacts on male fertility are caused by existing combined exposures to dangerous chemicals, many of which are linked to plastics. 

Replacing chemicals and plastic with more environmentally friendly substitutes 

Since using drop-in chemicals (i.e., replacement chemicals that can be utilised without affecting existing production processes) is easiest and frequently seen as most technically viable, dangerous chemicals in plastics are currently generally substituted chemical-by-chemical. 

However, it is frequently necessary to consider several other options in addition to particular drop-in chemicals from a much wider perspective. Drop-in chemicals frequently have physicochemical features that are strikingly similar to those of the chemicals they replace; as a result, they may have effects on human and environmental health that are comparable to or even worse. 

PLASTIC WASTE MANAGEMENT IN A CIRCULAR ECONOMY 

As per the UN-report the following key points can be referred for the waste management. 

1. Global plastic flow and waste management 

2. Challenges of recycling, energy recovery and managing plastics containing hazardous chemicals 

3. Options for recycling and managing plastics containing hazardous chemicals. 

4. Developing capacity for waste management, recycling, recovery, and destruction 

On 17 April 2023 the European Commission notified proposed revision of the Classification, Labelling and Packaging (CLP) Regulation to the WTO. The proposal was originally published on 19 December 2023.  The revision of the CLP and the planned revision of REACH are important parts of the Chemicals Strategy for Sustainability (CSS) framework which again is a key building block of the European Green Deal. The revision package aims to:

• Ensure that all hazardous chemicals including those with endocrine disruptive (ED), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), and very persistent and very mobile (vPvM) properties are classified adequately and uniformly throughout the EU. The new hazard classes are already implemented through the Delegated Act of 20 April 2023. Read more here.

• Improve the efficiency of hazard communication by making labels more accessible and understandable for users of chemicals. Provide companies with more flexibility and thereby reducing the administrative burden without lowering safety levels.

• Ensure that the rules on chemical hazard classification and communication are applied by all relevant actors in the supply chain.

The revised regulation will be clearer on labelling issues such as readability and digital labelling. It will also increase compliance with CLP for online sales of chemicals. This will help businesses, including SMEs and the free movement of substances and mixtures within the EU market. The revision will introduce the following:

• Better and faster processes for all actors to inform on hazards of chemicals placed on the EU market.

• Improved communication of chemical hazards, including online, through simpler and clarified labelling and advertising requirements.

• The right for the European Commission (in addition to Member States and industry) to develop classification proposals on potentially hazardous substances, speeding up the pace at which hazardous substances can be identified.

• The first ever specific rules for refillable chemical products so consumers buy and use these products (e.g. home care chemicals) in a safe way.

The proposal in currently undergoing the Ordinary Legislative Procedure. The EU Parliament and the EU Council are expected to formally adopt the new legislation in the first quarter of 2024.

On 5 May 2023 the European Food Safety Authority (EFSA) requested additional evidence regarding the potential migration of plasticisers from food contact materials (FCMs). Stakeholders and interested parties can submit their information until 30 June 2023.

Upon the European Commission's request, EFSA is conducting a re-evaluation of phthalates, substances with similar structures, and alternative materials utilized in FCMs. To facilitate this process, EFSA has extended an invitation for data submissions from various entities, including national food authorities, research institutions, academia, and food business operators.

This is the second call for evidence on migration data in relation to dietary exposure assessment, following a consultation conducted last year. Phthalates, terephthalates, citrates, and benzoates are some of the plasticisers that will be evaluated.

Previously, in January 2023, the European Commission proposed an update to the regulation governing plastics used in FCMs. This proposed update would introduce changes to existing authorizations and specific migration limits (SMLs) for certain uses of phthalates such as dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), diethylhexyl phthalate (DEHP), and diisononyl phthalate (DINP).

At the 11th meeting of the Conference of the Parties (COP) to the Stockholm Convention on 5 May 2023, more than 120 countries agreed to add 2 plastic chemicals and one pesticide to the Conventions list of substances for global elimination (Annex A). The delegates to the COP found that the chemicals, the plastic additive UV-328, the flame retardant Dechlorane Plus (also often used in plastics), and the pesticide methoxychlor all meet the Convention criteria as persistent organic pollutants (POPs) required for a global ban.

The uses and hazards of the 3 substances are:

However, time-limited exemptions were agreed on for the use of UV-328 and Dechlorane Plus. The expemtions are summarised in the tables below.

Several countries called for labelling of products that contain the 2 plastic additives while others opposed. The Convention’s Scientific Review Committee plans to evaluate options for identifying POPs in products and waste.

On 28 April 2023 the European Commission put forward a proposal for a revised Regulation on detergents and surfactants that would amend Regulation (EU) 2019/1020 and repeal Regulation (EC) No 648/2004. The new proposal introduces digital labelling and product passports for detergents and surfactants, new requirements for cleaners containing micro-organisms as well as rules for refilled detergents. This proposal updates the existing rules in line with the objectives of the European Green Deal, the Chemicals Strategy for Sustainability and the recently adopted Commission Communication on the long-term competitiveness of the EU.

Detergents are chemicals with intrinsic properties that have the potential to pose risks to human health and the environment. In order to be placed and move freely on the EU market detergents need to comply with Regulation (EC) No 648/2004 (the ‘Detergents Regulation’) from 2004. The regulation contains labelling and biodegradability requirements and phosphorous limits. However. the Detergents Regulation does not take into account innovative products such as microbial cleaning products and sustainable new practises such as refill sales. Furthermore, there are overlaps between the Detergent Regulation and the Classification, Labelling and Packaging (CLP) Regulations leading to e.g. duplication of information of the emergency health response for detergents classified as hazardous under the CLP Regulation. The revised Regulations will address these issues.

The revised Regulation will ensure that the EU rules specific for detergents remain complementary to the general provisions applicable to chemicals i.e. the CLP Regulation and the REACH regulation. The revised Regulation puts forward the following changes:

Introduction of safety requirements for micro-organisms in detergents: New innovative cleaning products that use the action of micro-organisms have recently been developed. The revised Regulation will introduce safety requirements for micro-organisms in detergents. Furthermore, manufacturers must label the presence of micro-organisms in the detergents. This will allow these products to move freely in the Single Market and contribute to protecting human health and the environment since they may be alternatives to harmful chemicals.

Introduction of product passports: A product passport that contains compliance information will be introduced which will reduce the amount of non-compliant detergents and surfactants on the market in the EU. A detergent that is presented at customs can only be released for free circulation ad placed on the market if it has a corresponding product passport. National inspectors will continue to be responsible for carrying out checks on products, although a new IT system will screen all digital product passports at the external borders.

Introduction of voluntary digital labelling: For pre-packaged products some of the mandatory labelling information may be move to a digital label. For refillable products all labelling information may be provided digitally – except for dosage instructions for consumer laundry detergents.

Introduction of rules for refilled detergents: Under the revised Regulation refilled detergents are subject to the same rules as pre-packaged detergents. Furthermore, voluntary digital labelling is introduced for refilled detergents to further facilitate the use of these as this is sustainable and reduces packaging waste.

Simplification of market rules by abolishing unnecessary or redundant requirements: The following rules in the Detergent Regulation will be abolished:

• the obligation to provide an ingredient data sheet for hazardous detergents

• the obligatory involvement of approved laboratories performing tests

• the possibility to request a derogation for surfactants that do not meet the criteria of ultimate biodegradability

• the obligation for detergent and surfactant manufacturers to be established in the EU

Furthermore labelling requirements will be simplified and streamlined to reduce the administrative burden for the industry and making them easier to understand for end-users.

The complete text of the revised Regulation can be found here: https://single-market-economy.ec.europa.eu/publications/com2023217-proposal-regulation-detergents-and-surfactants_en

The European Commission has finally adopted restrictions prohibiting the use and sale of lead in polyvinyl chloride (PVC) articles, including imports in order to safeguard individuals and the environment against the harmful impacts of lead. The primary beneficiaries of this measure are people's health, especially children. These efforts align with the objectives of the Chemical Strategy for Sustainability and the European Green Deal.

Lead compounds are commonly found in PVC products used in the construction industry, such as window profiles, pipes, tubes, wires, and cables. Implemented within the framework of EU REACH, this restriction is expected to prevent the release of approximately 8.4 tonnes of lead emissions annually.

Since the regulation’s entry into force on 28 May, the industry has 18 months to transition and must now add a warning label to the packaging of relevant products.

To encourage recycling and reduce carbon emissions by 1.5 million tonnes annually, items made from recycled rigid PVC can still be sold and used for ten years after the 28 May entry into force. However, only if the rigid PVC contains less than 1.5% lead in the recovered rigid PVC, and less than 0.1% lead for a layer of newly produced PVC. Furthermore, these recycled rigid PVC items must be entirely coated with a lead-free layer to ensure safety and prevent accidental exposure to lead for both people and the environment.

The United Nations Recommendations on the Transport of Dangerous Goods, commonly known as the UN Model Regulations, are maintained, and amended by the UN Sub-Committee of Experts on the Transport of Dangerous Goods (TDG Sub-Committee). The UN Model Regulations, which are updated every two years, serve as the foundation for unified international and national dangerous goods transit legislation.  

Following the UN Committee of Experts' acceptance of the revisions to the UN Recommendations on the Transport of Dangerous Goods in December, the 23rd amended edition will shortly be released. Duty holders do not need to take any action at this time because the revisions won't take effect until the beginning of 2025. The numerous model, regional, and national agencies in charge of the laws that businesses must abide by will spend the interim time incorporating the revisions into their rules. 

Listing and distinctive provisions  

The following list contains  some of the significant modifications made to the 23rd updated edition of the Model Regulations: 

•  New entries in the Dangerous Goods List 

• One new special provision specific to sodium ion cells and batteries, namely SP 401New paragraph added after paragraph 5:  UN 3556 VEHICLE, LITHIUM ION BATTERY POWERED, UN 3557 VEHICLE, LITHIUM METAL BATTERY POWERED and UN 3558 VEHICLE, SODIUM ION BATTERY POWERED, as applicable, apply to vehicles powered by lithium ion, lithium metal or sodium ion batteries transported with the batteries installed.     

• The final two phrases in the former paragraph 6 (now paragraph 7) have been merged to form the following:    

• UN 3558 is subject to a new SP 404, while the three newly adopted entries for battery-powered vehicles are all subject to a new SP 405 

• A new SP 400 grants a broad exemption for UN 3552 alone, acknowledging the negligible risk that sodium ion batteries in equipment represent. 

• A new SP 407 is necessary due to the implementation of new entries for fire suppressant dispersion equipment. 

• Only Class 9 of the UN 3559 standard shall be applied to fire suppression dispersal equipment. 

• SP 408 and SP 409, two brand-new special provisions, have been approved and assigned to UN 1835. 

• Additionally, SP 310 has been changed to read as follows: "2.9.4 (a), (e) (vii), (f) (iii), (f) (iv), and (g) shall not apply to cells or batteries from production runs of not more than 100 cells or batteries, or pre-production prototypes of cells or batteries when these prototypes are transported for testing."  

On the UNECE website, the online version of the 23rd revised edition of the UN Model Regulations will be released when it is ready (for reference, the 22nd revised edition debuted in September 2021); a notice will be posted on the publications page and the dangerous goods main page. 

On 5 August 2021, the Commission Regulation (EU) 2021/1297 was released to restrict the use of perfluorocarboxylic acids (C9-C14 PFCAs), their salts, and C9-C14 PFCA-related compounds under entry 68 of REACH Regulation (EC) No. 1907/2006 Annex XVII.   

Starting on 25 February 2023, there is an EU-wide update for restriction on perfluorocarboxylic acids (PFCAs) with a chain of 9 to 14 carbon atoms, as well as their salts and related compounds.  . Some uses have been granted longer transition periods.  

The restriction will take effect on 4 July 2023, and it will apply to PFCAs used in the production of specific products such as polyvinylidene fluoride (PVDF) and polytetrafluoroethylene (PTFE), as well as textiles that are oil- and water-resistant to protect workers from hazardous liquids that could endanger their health and safety. 

From 4 July 2025 onwards the restriction will apply to substances used in invasive and implantable medical devices, photolithography or etch processes in semiconductor manufacturing, photographic coatings applied to films, and firefighting foam for liquid fuel vapour suppression and liquid fuel fire. 

Fluoropolymer and fluoroelastomer manufacture, as well as the production of PTFE micropowders, are all permissible under exemptions granted by the European Commission. 

For the total of C9-C14 PFCAs in fluoroplastics and fluoroelastomers containing perfluoroalkoxy groups, the concentration limit will be 2,000 parts per billion (ppb) up until 26 August 2024. However, this limit will thereafter be lowered to 100 ppb. Also, the Commission has established a limit of 1,000 ppb for the total amount of C9-C14 PFCAs, their salts, and associated compounds when present in PTFE micro particles. Both exemptions will be evaluated by 26 August 2024. 

Per- and polyfluoroalkyl substances (PFASs) include PFCAs as a subset. The much-awaited ECHA proposal to set limits on more than 10,000 PFASs was released last month. 

On 22 March 2023 the European Chemical Industry Council (Cefic) and 30 other associations representing market sectors in the European plastics value chain published a joint letter to the European Commission. In the letter they call on the European Commission and Member States to adopt EU harmonized calculating rules for recycled content, by means of mass balance credit method with a fuel-use exempt model, in 2023. The Single Use Plastics Directive (SUPD) Implementing Act should be used as legal foundation.

The mass balance chain of custody tracks specific characteristics and guarantees that the chemically recycled monomers and basic polymers are correctly certified. This methodology is already used in other sectors where sustainable materials are included in a mixed production process such as fair-trade cocoa and chocolate.

In order to reach the EU’s 2050 climate and circularity targets the chemical recycling infrastructure needs investments. The Plastic industry needs legal certainty on the mass balance chain of custody in order to make the necessary investments in the recycling infrastructure.

On 10 May 2023 the British government presented an amendment to the Retained EU Law (Revocation and Reform) Bill removing the sunset clause that would automatically revoke most retained EU law on 31 December 2023.

Originally the Retained EU Law (REUL) was established by the European Union (Withdrawal) Act 2018 to guarantee legal certainty and continuity in the period after Brexit by keeping all EU and EU-derived law as it was on 31 December 2020 when the UK left the EU.  On 22 September 2022 the Government presented the Retained EU Law (Revocation and Reform) Bill to Parliament. The Bill contains a sunset clause that would revoke the majority of REUL on the 31 December 2023 unless positive steps were taken by the government to keep it. REUL consists of around 4,800 pieces of legislation that must be reviewed before it can be decided if they should be preserved, reformed, or revoked.

The amendment to the Retained EU Law (Revocation and Reform) Bill presented on 10 May removes the sunset clause from the Bill. Instead it presents a list of approximately 600 retained EU laws that the government intends to revoke at the end of 2023. The list contains REUL that is obsolete now that the UK has left the EU. The remaining legislation will be retained but can be revoked or reformed later after proper assessment and consultation. The full list can be found here. It contains a variety of legislation concerning biocides, persistent organic pollutants (POPs), import and export of substances subject to the prior informed consent (PIC) regulation, CLP Annex VIII obligation related to poison centers, food additives and environmental permits. 

On 20 April 2023, the UK Department for Environment, Food and Rural Affairs (DEFRA) laid a draft Statutory Instrument (SI), REACH (Amendment) Regulations 2023, before Parliament. The SI will formally extend the submission deadlines under UK-REACH by 3 years.

The table below shows the original and new deadlines for the various tonnage bands and hazard categories.

The changes will come into force after approval by each of the Houses of Parliament. This SI is expected to be enacted and in force by the third quarter of 2023.

Since Ukraine became an EU candidate in June last year the country has been working on aligning its chemical policy with EU REACH. Last December the country published the law on chemical safety and management of chemical products in accordance with the EU legislation.

Furthermore, Ukraine has issued a draft resolution in accordance with the 1998 EU Directive on protection of employees from harmful chemicals where it lists hazardous substances prohibited for production.

Now, Ukraine is aligning its chemical regulations with the EU's CLP system. The country is set to adopt its first technical regulation on hazard classification, labelling, and packaging of chemical products this summer.

Ukraine's recent law on chemical safety and product management laid the groundwork for aligning with EU legislation, outlining basic hazard classification principles and general labelling rules. However, the proposed CLP Regulation takes it a step further by introducing comprehensive rules to protect human health and the environment from hazardous chemicals, ensuring their free circulation in the domestic market, and establishing a national list of approved hazard classifications and labelling elements.

The Ministry of Environmental Protection and Natural Resources anticipates that most aspects of the Regulation will come into effect on 9 July 2023. However, certain elements, including identifiers for dangerous chemical products, alternative substance names, packaging and storage requirements, and requests for new information, are expected to be implemented by 29 June 2024.

To gather feedback, the draft CLP Regulation is currently open for comments via the WTO until 20 June, allowing stakeholders to contribute to the regulatory process.

On 12th May 2023, the Ministry of Environment, Urbanization, and Climate Change of Turkey made an announcement for the substances, mixtures, or articles which are subject to registration under KKDIK.

According to the KKDIK Regulation (Bylaw on Registration, Evaluation, Authorization, and Restriction of Chemicals), whether the substances produced or imported in an annual amount of 1 ton or more in their own form, in the mixture, or in the article are within the scope of KKDIK, and if they are in the scope, whether they are subject to registration requirements are included in the second article of the KKDIK Regulation, titled "Scope".

In addition to that, useful guides on the implementation of the KKDIK Regulation have been published on the Ministry’s website.

In this context, considering the fact that companies are the most reliable owners of information about their own production processes and chemicals and the above explanations, by evaluating the guides in the help desk, primarily the "Registration Guide"; it is expected that the Chemical Evaluation Experts (KDU) determined by the parties or other expert authorities make a determination as to whether the substance, mixture or articles are subject to registration, and do not apply for the written approval of the Ministry in this regard. The Ministry does not issue an approval letter on the subject.

The deadline for KKDIK registration, 31 December 2023, is not expected to be postponed. We suggest that industry representatives should complete the process as soon as possible since substances not registered after the deadline will not be able to enter the Turkish market.

At the 11th meeting of the Conference of the Parties (COP) to the Stockholm Convention on 5 May 2023, more than 120 countries agreed to add 2 plastic chemicals and one pesticide to the Conventions list of substances for global elimination (Annex A). The delegates to the COP found that the chemicals, the plastic additive UV-328, the flame retardant Dechlorane Plus (also often used in plastics), and the pesticide methoxychlor all meet the Convention criteria as persistent organic pollutants (POPs) required for a global ban.

The uses and hazards of the 3 substances are:

However, time-limited exemptions were agreed on for the use of UV-328 and Dechlorane Plus. The exemptions are summarised in the tables below.

Several countries called for labelling of products that contain the 2 plastic additives while others opposed. The Convention’s Scientific Review Committee plans to evaluate options for identifying POPs in products and waste.

On 2 May 2023, the Indian Ministry of Environment, Forest and Climate Change (MoEF) published a draft notification in the Gazette of India for bringing out regulations for Extended Producer Responsibility (EPR) for used oil. The public and other stakeholders have 60 days from the date of publication of the draft to make any objection or suggestions on the proposals contained in the draft notification.

Used oil is a major environmental hazard if it is not disposed of properly. One litre of used oil can contaminate 1 million litres of fresh water. The aim of the draft notification is to promote circular economy for used oil such as re-refining of used lubricants which could have both environmental and economic benefits.

The EPR for used oil is notified under the Hazardous and Other Wastes (Management
and Transboundary Movement) Rules, 2016. The latest amendment of these rules is the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2023 which will come into force on 1 April 2024.

The definition of used oil is defined in subrule 36 of rule 6 of Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 as:

• Any oil derived from crude oil or mixtures containing synthetic oil including spent oil,
  used engine oil, gear oil, hydraulic oil, turbine oil, compressor oil, industrial
  gear oil, heat transfer oil, transformer oil and their tank bottom sludges.

• Any oil suitable for reprocessing, i.e. oil that does not include waste oil and meets the limits for polychlorinated biphenyls (PCBs), lead, arsenic, cadmium, chromium, nickel and polyaromatic hydrocarbons (PAH).

Under the draft notification producers, collection agents, recyclers and used oil importers will have to register on the online system developed by the Central Pollution Control Board. The portal will also be used for filing quarterly and annual returns, EPR certificate and tracing of oil produced or generated by the stakeholders.

EPR obligations for producers of base oil or lubrication starts at 10 % of the oil sold or imported in the year 2022-2023 and increases by 10 % for each of the following 5 years. EPR obligations for used oil importers is 100 % of the imported oil. The import of used oil is permitted only for the purpose of re-refining.

The complete text of the draft notification can be found here: https://egazette.gov.in/WriteReadData/2023/245597.pdf

On 27 April 2023 the Indian Ministry of Environment, Forest and Climate Change published a notification in the Gazette of India announcing the Plastic Waste Management (Amendment) Rules, 2023. The Rules came into force on the day of publication in the Gazette and are an amendment to the Plastic Waste Management Rules, 2016 previously amended by the Plastic Waste Management
(Second Amendment) Rules, 2022.

The following amendments have been made to the Plastic Waste Management Second Amendment Rules, 2022:

Rule 10. Protocols for compostable and biodegradable plastic materials.

The deadline for the provisional certificates for biodegradable plastics issued by the Central Pollution Control Board (subrule 5) has been prolonged by one year. The provisional certificates shall be valid till 30 June 2024 with the condition that production or import of biodegradable plastic shall cease after 31 March 2024.

Rule 11. Marking and labelling

The rule that each plastic carry bag must have name, registration number of the producer or brand owner, and the thickness in case of carry bag and plastic packaging does now not apply to ‘rigid plastic packaging’.

Rule 13. Registration of producer, recyclers and manufacturer

Every producer or importer shall for the purpose of registration make an application as per the guidelines specified in Schedule II. The renewal of registration has been omitted (from Subrule 2). The registration granted under this rule shall be changed only on the request of Producers, Importers
& Brand owners, under the existing Extended Producer Responsibility registration. The registration granted under this rule shall be valid for a period of one year, unless revoked,
suspended or cancelled and shall subsequently be granted for three years.

Schedule II. Guidelines on Extended Producers Responsibility (EPR) for Plastic Packaging

• Clause 6.6: The details regarding registration on the EPR portal have been modified. The following is now valid: While registering, the entities shall have to provide PAN Number, GST Number, CIN Number of the company in case of company and the entities may provide Aadhar Number and shall provide PAN Number of authorized person or representative and any other necessary information as required.

• Clause 10.6: Producers, importers and brand-owners must file annual returns on the collected plastic packaging waste on the EPR portal by 30 June of the next financial year. Provided that the last date for filing of annual returns for the financial year 2022-2023 is the 31 October 2023.

• Clause 11.2: Plastic waste processors (recyclers or other waste processors including composting facilities) must submit annual returns after the end of each financial year by 30 April. Provided that the last date for filing of annual returns for the financial year 2022-2023 is the 31 July 2023.

The Offcial Gazzette can be found here: https://egazette.nic.in/WriteReadData/2023/245496.pdf

The National Health Commission of China published a notification which approved 2 substances to be categorized as new food materials, 6 substances to be categorized as new food contact materials (FCM), and 6 substances to be categorized as food related products new materials. There are in total 14 substances which were approved to use under certain conditions by this notification. 

1. 2 substances were approved as new food materials 

The two substances which were approved as new food materials are Blueberry Anthocyanins and Rye Pollen. The use of them is strictly limited according to the annex of the notification report. 

2. 6 substances were approved as new FCM

The six substances which were included for use as FCM are 

• L-Se-methylselenocysteine, 
• D-psicose 3-epimerase, 
• L-ascorbgy Palmitate, 
• Vitamin B1, 
• Vitamin B2 and 
• Taurine. 

The NHC has approved it for use in coatings and coating layers, at a maximum usage of 5%. However, it cannot be used in FCMs for infants and toddlers.

3. 6 substances were approved to use in food related products as new materials 

The six substances which were permitted to use in food related products are 

• Hexanedioic acid polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 
• 4-tert-butylbenzoic acid, Tricyclodecanedimethanol polymer withterephtalic acid and 1,6-hexandiol, 
• Fatty acids, C18-unsatd., dimmers, hydrogenated polymers with 1,4-butanediol, ethylene glycol, terephthalic acid and trimethylolpropane, block, 
• 1,6-Hexanedioic acid, polymer with (E)-2-butenedioic acid and tricyclodecanedimethanol, 
• Polymer of 1,4-butanediol, 2,2-dimethyl-1,3-propanediol, 1,4-cyclohexanedicarboxylic acid andm-phthalic acid, and 
• Polymer of butanediol-1,4, tricyclodecanedimethanol and dimethyl terephthalate. 

Manufacturers must label packaging containing any of the substances in accordance with the provisions set out in national standard GB 4806. If you need any help regarding China regulatory compliance work, please contact GPC via compliance@gpcregulatory.cn for help.

On 4^th May 2023, National Institutes for Food and Drug Control of China published a notification calling for public opinions on the Guidance for Cosmetic ingredient safety information submission. According to technical guidance on cosmetic safety evaluation (2021 edition), when conducting the cosmetic risk evaluation, the risk of all ingredients must be evaluated. Thus, this Guidance was made to guide the filling of ingredients information. 

There are eleven sections in the Guidance. The first to third section are set for general principles which gives information about the preface, application scope and general principles. The fourth to tenth sections include the main contents of the basic information, manufacturing process and quality control requirements of ingredients. In addition, the Guidance also considers the requirements on evaluation conclusion from international authorities, use in other industries, risk ingredient’s limitation. The last part clarified the conditions and procedures for cosmetic registers or record fillers to update ingredients information under certain conditions. 

The public consultation period is open until 20^th May 2023. If you have any opinions regarding this guidance, you are welcome to contact GPC via compliance@gpcregulatory.cn. We can help you to submit the opinion. 

The Standardization Administration of China and State Administration for Market Regulation jointly published the revised version of national standard on Lip moisturizer (gel and cream), GB/T 26513-2023. This revision will replace the previous one of GB/T 26513-2011. 

The new standard covers the following sections. 

• the definition of a lip moisturiser; 
• technical terms; 
• classifications; 
• product technical requirements; 
• test methods and testing rules; 
• labelling and packaging requirements; 
• transport and storage requirements; and 
• shelf-life details

Compared to the previous standard, the scope of lip moisturizer was broadened, the classification criteria and label were modified. The new standard is expected to come into force from first April 2024. If you have any questions regarding this standard, you are welcome to contact GPC via compliance@regulatory.cn.

On 17 May 2023, the Chemical Materials Research Division of the National Institute of Environmental Research uploaded its plans to conduct evaluations of biocidal substances submitted for approval under the "Act on the Safety Management of Household Chemical Products and Biocides." 

In relation to this, the authority has provided guidance regarding the exemption of efficacy test data for biocidal substances (wood preservatives). 

The Exemption Guidelines for Test Data on Efficacy and Effectiveness of Biocidal Substances (Wood Preservatives) are as follows: 

 
For wood preservatives listed under the Korean standard on wood preservatives and similar substances, the submission of test data on efficacy and effectiveness may be exempted according to the Industrial Standardization Act. KSM 1701 is a standard number issued by the government agency, the Korea Agency for Technology and Standards (KATS), to designate wood preservatives. 

 
Seven out of the 40 existing wood preservatives are subject to deferred approval in 2024. When applying for approval of these confirmed biocidal substances and their representative example products, the submission of test data on efficacy and effectiveness is exempted. 
However, general data on the efficacy and effectiveness of the biocidal substances (such as their functions, control methods, mechanisms of action, limitations, etc.) should still be submitted. 
The exemption for test data on efficacy and effectiveness only applies to wood preservatives and does not extend to other types of biocidal products. The exemption for test data on efficacy and effectiveness of wood preservatives is independent of the designation of existing biocidal substances and internationally approved evaluated substances. Changes in the inclusion or removal of substances under KSM 1701 may result in modifications to the eligibility for exemption from test data on efficacy and effectiveness. 

 
For wood preservatives that are not included under KSM 1701, test data on efficacy and effectiveness should be submitted when applying for their approval. If the efficacy and effectiveness of the biocidal substance are not sufficiently proven or if individual testing is not feasible, evaluation of the representative example product can be used to demonstrate the efficacy and effectiveness of the biocidal substance. As wood preservatives fall under the category of preservatives used in biocidal treatment products, test data demonstrating the desired efficacy and effectiveness in treated biocidal products using the representative example product should be submitted. Both domestic and internationally recognized test methods can be used for evaluating the efficacy and effectiveness of wood preservatives. Refer to the information provided in the Chemical Products Management System.  

Please note that the information provided is based on the referenced guidelines and regulations. It is advisable to consult the official regulatory authorities or seek legal guidance for precise and up-to-date information regarding the exemption of test data on efficacy and effectiveness for wood preservatives. 

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on May 9th, 2023. This is to notify substance name, hazard information, classification and etc as the hazard reviews are completed for registered substances.

The draft amendment mainly proposes revisions including:

• Notification of the results of hazard review of registered chemical substances: 37 new substances
• Revision of notified substances: 30 new substances

If you have any opinion on this amendment, please write your opinion and submit it to the NIER.

The deadline for this consultation is May 29th, 2023.

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Regulations on quasi-drug classification numbers on May 9th, 2023. This is to improve the efficiency of quasi-drug product approval (report) by updating the quasi-drug classification numbers.

The main amendments are:

• Assign quasi-drug classification numbers to ‘products used for sanitary treatment of bleeding and lochia (postpartum vaginal discharge) after childbirth’ that are newly designated as quasi-drugs: Quasi-drug classification number 3510, 3520, 3530, and 3600
• Remove the quasi-drug classification number of items converted to biocides, according to the Consumer Chemical Products and Biocides Safety Control Act (K-BPR): Quasi-drug classification number 4300, 4310, 4910, 5100, 5110, 5120, 5200, 5210, and 5220

If you have any opinion on this draft amendment, please write your opinion in the provided format and submit it to MFDS.

The deadline for this consultation is May 29th, 2023.

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Regulations on Safety Standards for Cosmetics on May 4th, 2023. This is to reinforce cosmetic safety management and protect human health by adding some hair dye ingredients to the prohibited list of cosmetics, considering the results of risk assessment and overseas regulatory trends.

The main amendments are:

• Add 7 hair dye ingredients to the prohibited list of cosmetics
• Lower concentrations upper limits for 2 hair dye ingredients

If you have any opinion on this draft amendment, please write your opinion in the provided format and submit it to MFDS.

The deadline for this consultation is July 4th, 2023.

The Ministry of Food and Drug Safety (MFDS) in South Korea updates the designation of usage standards of cosmetic raw materials, especially on UV protection ingredients, under the Cosmetic Act on May 4^th, 2023. This is to notify the list of cosmetic raw materials and its usage standard based on the screening results.

The main update is as follow:

• UV protection ingredients

In April 2023, Taiwan’s EPA published two draft documents for dossier preparation and is now searching for public comments. The first document is the Overview of QSAR Model Validation Methods (draft) (in Mandarin). The document was initially prepared by the European Chemicals Agency (ECHA) and the OECD. With the permission from the OECD, Taiwan’s Toxic and Chemical Substances Bureau (TCSB) translated the “Guidance Document on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models, OECD Series on Testing and Assessment, No. 69, OECD, 2014” into Mandarin to facilitate the preparation of dossiers for companies.

The second document considers the grouping of chemicals, based on the document the “Guidance on Grouping of Chemicals, Second Edition, OECD Series on Testing and Assessment, No. 194, OECD, 2017” published by the OECD. This document is also translated into Mandarin. The purpose of this document is to avoid unnecessary animal testing when alternative methods are available for data generation.

The authority specifies that these two documents can only be used as reference documents. Compliance obligations need to follow the Regulations of New and Existing Chemical Substances Registration.

Both documents are available on TCSB’s website. Comments for these two draft documents are welcome and should be sent via mail to Chemist@eri.com.tw.

In March 2023, Japan’s Ministry of Health, Labour, and Welfare (MHLW) proposed revised guidelines for measuring workplace exposure limits for hazardous substances under the country’s Industrial Safety and Health Act (ISHA).

A public consultation on the revised technical guidelines for the application of concentration standards was initiated in March 2023, by the MHLW in order to reduce health risks from chemical compounds. The consultation ended on 5 April 2023. The guidelines are expected to be enforced on 1 April 2024.

The guidelines include details on the risk reduction measures, workplace concentration standard values (exposure limits) with their application, and workplace exposure measuring methods for 73 substances including their sampling and analysis methods.

The list of substances includes:

On 16 March 2023, Japan announced the inclusion of 1,469 substances to the list of chemicals for which companies are required to maintain safety data sheets (SDSs) and labels that comply with the UN's Globally Harmonised System of classification and labelling (GHS) in accordance with the country's Industrial Safety and Health Act (ISHA).

There will be two phases of enforcement. The list of substances in Appendix 1 of the notice has a proposed enforcement date of April 2025, and the list of substances in Appendix 2 has a proposed enforcement date of April 2026; however, according to the WTO notice these dates are subject to change.

There are total 651 substances included in Appendix 1 examples are-

Appendix 2 consists of total 818 substances which includes-

In Japan, the GHS is implemented under three laws, which include the Industrial Safety and Health Act (ISHL), the Pollutant Release and Transfer Register (PRTR) Law, and the Poisonous and Deleterious Substances Control Act (PDSCL).

According to the MHLW, it will be necessary for companies to label containers or packages containing the chemicals with specific information, including the substance name, based on the sixth revised edition of the GHS.

In a notice published on March 31, 2023, the Japanese Ministry of Economy, Trade, and Industry (METI) and the ministries of Health, Labour, and Welfare (MHLW) and Environment (MOE) announced the removal of six substances from their priority assessment chemicals (PACs) list under the country's Chemical Substances Control Law (CSCL).

The six substances that have been removed are:

• Ethylamine
• Methyl dodecanoate
• Benzoic acid benzyl ester
• Camphene
• O-dichlorobenzene
• Chlorodifluoromethane (HCFC-22)

Priority assessment chemicals (PACs) are the substances that METI believes may be hazardous to the environment or human health. Companies must submit annual reports to METI for these substances when manufacturing or importing them in volumes of one tonne or more per year.

According to the National Institute of Technology and Evaluation’s (NITE) Chemical Risk Information Platform, there are a total of 218 substances listed under the PAC list. The six substances removed from the PACs list no longer require annual reporting as they are now classified as general chemicals.

On 4 May 2023, Australia Industrial Chemicals Introduction Scheme (AICIS) repealed CBI acceptance for the proper name of 2 Industrial Chemicals in the Australian Inventory of Industrial Chemicals (AIIC). These chemicals are listed below: 

Other updates on cancellation and addition of chemicals to AIIC: 

On 9 May 2023 the Brazilian Chamber of Deputies approved Bill 6120/2019. The Bill will now move on to the Senate for consideration. It is now set to be reviewed by the Environment Committee (CMA) and the Committee on Social Affairs (CAS). The Bill had been shelved since 2019 when President Bolsonaro came into office.

If Bill 6120/2019 is approved in Senate and signed into law it would:

• Establish a National Inventory of Chemical Substances

• Adopt GHS as the mandatory classification system

• Set up an Assessment Committee to assess the risks of the substances and recommend risk management measures

So far, the only Latin American countries that have implemented national chemicals legislation are Chile and Colombia. According to a statement made by Melissa Owen, founder of law practise Ambiente Legal, on LinkedIn there is ‘a distinct possibility that the Bill could be approved as early as this year’ making Brazil the third country in the region to adopt a national chemical legislation.

Last month the Constitution, Justice, and Citizenship Committee at the Brazilian Parliament reopened the debate about bill PL 6120/2019. This is a bill that seeks to create the Inventário Nacional de Substâncias Químicas (The Chemical National Inventory of Brazil), a national database that will consolidate information on chemical substances produced or imported in the country.

The bill was approved by the Commission for Economic Development, Industry, Commerce and Services of the Brazilian Chamber of Deputies on November 23, 2022 and is still in the approval process.

This is a national framework for chemical legislation that is back on track. the Bill is under the consideration of the Constitution, Justice, and Citizenship  Committee. In this case, the Bill will not require a plenary vote after this last Committee, as it would be considered approved by the Chamber of Deputies and move on to the Senate.

Last month, the Committee reopened the amendment period for five additional sessions and discussed appointing a new rapporteur. However, time has run out on these sessions, and no changes were made. The original rapporteur's opinion still stands, and the Bill is ready for a decision in that Committee.

On March 13, 2023, the Vietnamese Ministry of Natural Resources and Environment promoted Circular No. 01/2023/TT-BTNMT which leads to establishment of new National technical regulations (QCVN) on different environmental qualities.

These regulations will come into force from September 12, 2023, and will be replacing previous regulations for ambient air, soil, surface water, underground water, and marine water.

The renewed regulations consist of following:

5. National Technical Regulation on Soil Quality (QCVN 03:2023/BTNMT)

5. National Technical Regulation on Ambient Air Quality (QCVN 05:2023/BTNMT)

5. National Technical Regulation on Surface Water Quality (QCVN 08:2023/BTNMT)

5. National Technical Regulation on Underground Water Quality (QCVN 09:2023/BTNMT)

5. National Technical Regulation on Marine Water Quality (QCVN 10:2023/BTNMT)

These regulations are updated against previous existed environmental regulations in Vietnam. The renewed QCVN on soil is a compilation of previous four QCVNs as one.

The idea to renew regulations that are concerned with the regulation of emissions such as wastewater and exhaust gas seems to be litigious and will be revealed separately.

The Department of Occupational Safety and Health (Dosh) in Malaysia is planning to update the instructions on how to create and submit chemical registers. Under the Occupational Safety and Health Act, manufacturers, suppliers, and users who process, produce, or store hazardous substances at the workplace are required to submit a register to the Director General of DOSH.

The proposed amendments to the Guidelines for the Preparation of a Chemical Register include a requirement that the register be submitted no later than 31 March of the year after their effective date and then each calendar year after that. When enforcement will begin is not known yet, according to the government. Moreover, they make it clear that the following details are necessary: list of chemicals; each chemical's most recent safety data sheet (SDS); average amount processed, generated, or stored per month or year; and chemical's physical state (liquid, gas, or another); the location where it is generated, processed, or stored; chemical hazard categorization; supplier information, and name and address.

The recommendations include a new suggested format in Appendix 1 of the guidelines. This refers to the dissemination of extra information, such as:

Information about the business, the person in charge of creating and approving the register, and a statement from top management that all personnel who could be exposed to hazardous substances would have access to the register.

They should be refreshed consistently, however, no time period was given.

The modifications, which were dependent upon a public discussion from 10 February to 10 March, plan to adjust the rules to the country's Occupational Safety and Health (Classification, Labelling and Safety Data Sheet of Hazardous Chemicals) Regulations, 2013, (CLASS Regulations 2013).

The Occupational Safety and Health (Use and Standard of Exposure Chemical Hazardous to Health) (USECHH) Regulations 2000 set compound substance openness norms to guarantee working environment wellbeing under the Occupational Safety and Health Act 1994 (OSHA 1994).

New Regulation on carbon pricing published by Indonesia. The Regulation of the Minister of Environment and Forestry No. 21/2022 on Procedure for Implementation of Carbon Pricing was declared in Indonesia on October 22, 2022.

The Regulation comprises of measures in order to reduce the emission of greenhouse gases (GHG) which involves trading of emission quotas, emission reduction incentives,and carbon taxes.

The “economic value of carbon” which in Indonesia is referred to as NEK (Nilai Ekonomi Karbon) is considered as the value of each unit of greenhouse gas emitted both through human and industrial activities. NEK initiates to take measures like carbon trading, emission reduction incentives (RPB: Result-Based Payments), and carbon levy, to reduce the emission of GHG. The record of GHG emission reduction target is to be maintained by business operators which is to be verified by an eligible third party. The National Registry System for Climate Change (SRN PPI) needs to take charge of the establishment of NEK measures by the state government.

The measure under the Regulation includes emission trading which consist of trading of emission quotas among different industrial entities. If a business operator’s emissions are less than its quotas, it can choose to either keep the remaining emissions for two years or trade them with other entities. For this a Certificate of GHG Emissions Reduction (SPE-GRKs) for the remaining quota should be issued by the government. In the contrary case, emission quotas can be purchased from other entities. Another measure under NEK is called carbon levy which comprises of imposition of tax based on carbon content emission.

On March 3, 2023, the Minister of Energy and Mineral Resources of Indonesia promulgated Regulation No. 2 of 2023 on the implementation of CCS and CCUS in Oil and natural gas business activities.CCS stands for carbon capture and storage whereas CCUS stands for carbon capture, utilization and storage .These processes require transportation of CO2 if CO2 is not being utilized or stored on site.

16 projects on carbon capture and storage (CCS) or carbon capture, utilization and storage (CCUS) are planned to come into operation before 2030.The Government Authority of Indonesia along with business investors and operators are looking forward to collaborating on this project and also towards carbon trading in order to elevate such projects economically which requires financial support and to become primed to manage risk and to manage an efficient security.

This project is also a way to increase the production of oil and gas and at the same time achieve the vision of reducing the emissions in the country to net zero by 2060.

This regulation facilitates an efficient mechanism for CCS/CCUS projects and a process by which these projects can be implemented and monitored while keeping up to certain standards. These standards have emerged out of experience of implementation of CCS/CCUS projects by other jurisdictions which still needs a bit more precision.

Indonesia hadn’t yet witnessed carbon trading and pricing being implemented there as whole. For CCS projects to work proficiently carbon trading has to be taken into consideration as it further impacts the business gained through CCS. CCUS on the other hand is capable enough to earn profit relying on utilization of carbon along with increased oil production but it fails to contribute towards storage of CO₂.

On 2 May 2023 the Chilean Ministry of the Environment (MMA) published Resolution No. 410/2023 that requests producers (including importers) of priority products to declare the quantity of products they have introduced to Chile during 2022. The Resolution relates to the EPR Law (Law 20920; Establishment of a Framework for Waste Management, Extended Producer Responsibility and Recycling) that requires producers of priority products to create management systems to meet mandatory take-back targets. The requested information must be submitted by 30 June 2023 through the website of the Pollutant Release and Transfer Register.

Resolution No. 410/2023 applies to producers of the following priority products:

• Lubricating oils

• Electrical and electronic equipment

• Batteries and small batteries

• Containers and packages (including those producers that introduce in the market less than 300 kg of containers, reusable containers and containers belonging to the subcategory "others")

• Bicycle, wheelchair, and solid tires

• Newspapers and magazines

Under the EPR law a producer of a priority product is defined as any who:

• sells a priority product for the first time in the national market,

• sells a priority product acquired from a third party that is not the first distributor under its own brand

• imports a priority product for their own professional use

Producers must report the amount of priority products in cubic meters and/or tons brought into the Chilean market during 2022.

On April 21, 2023, Chile approved a Technical Guide of Recommendation for the Labelling of Cosmetic Products. This regulation aims to provide guidelines on packaging and labeling requirements to ensure the safe use of cosmetics in Mexico. The regulation lists specific labeling requirements that manufacturers or importers of cosmetic products must adhere to, such as product denomination, cosmetic use, health registry number, registry number, series, validity period, net content, country of origin, manufacturer/importer/owner, use mode, warnings, specific labeling for special products, ingredients, and storage and conservation conditions.

The objective of this regulation is to promote the protection of the health conditions of the Mexican population by reducing the risks associated with the use of cosmetic products. Compliance with these requirements will be monitored by the Institute of Public Health and the Ministry of Health, who will serve as the regulatory authorities.

It's important to note that this regulation applies specifically to cosmetic products marketed in Mexico, regardless of their country of origin. Manufacturers and importers must ensure that their products comply with these labeling requirements before they can be sold in the Mexican market. Failing to comply with these requirements could result in fines or other regulatory actions. Therefore, manufacturers and importers should pay close attention to this new regulation and ensure that their products meet all the requirements listed in the Technical Guide of Recommendation for the Labelling of Cosmetic Products.

On 3 May 2023 the Mexican government published a decree adding, amending, and repealing various provisions of the Federal Law for the Control of Chemical Precursors, Essential Chemical Products and Machines to Manufacture Capsules, Tablets and/or Pills (in short, the Law on Chemical Precursors and Essential Chemical Products). The changes went into effect the day after the publication in the Official Gazette of the federation (i.e. on 4 May 2023) but the amendment to the regulation will be published within 180 days.

Some of the changes are:

• A synthetic drug is now defined as ‘Any substance of synthetic origin with psychoactive effects available in the illicit drug market and used for non-medical purposes.’

• Chemical precursors are defined as ‘Fundamental substances for the production of synthetic drugs, which incorporate their molecular structure into the final product.’

• Essential Chemicals are defined as ‘Substances that, without being chemical precursors, can be used to produce synthetic drugs, such as solvents, reagents, and catalysts.’

• The time for submitting Annual Reports has been changed to 60 calendar days.

• Affected companies and individuals must now register each activity the involves precursor chemicals or essential chemicals in the Comprehensive System of Substances within 24 hours.

• Penalties will now be as follows: A person who diverts or makes use of chemical precursors or essential chemicals for the production of synthetic drugs, will be sentenced to ten to fifteen years in prison and a fine equivalent to ten percent of the income obtained by such activities. A person who is in possession of chemical precursors, essential chemical products or machines to make capsules, tablets or tablets in the national territory, who does not have the corresponding authorizations or permits, will be sentenced to seven to ten years. imprisonment and a fine of one thousand to five thousand times the daily value of the Measurement and Update Unit.
  ·      

The full text of the decree can be found here:

https://www.dof.gob.mx/nota_detalle.php?codigo=5687756&fecha=03/05/2023#gsc.tab=0

On 2 March 2023, a draft standard was disclosed that involves two standards on marking and labelling requirements from 2008. The draft standard aligns Mexico’s rule with the UN model regulation. It describes the contents and sizes of labels when they are used on packages, containers, tank wagons, and freight containers.

Until 1 May, Mexico’s Secretariat of Infrastructure, Communications, and Transport (SICT), is consulting on the draft standard on marking and labelling.

The Secretariat of Infrastructure, Communications and Transportation (SICT) of Mexico is the national federal entity that regulates commercial road traffic and broadcasting. It sets and conducts policies and programs to develop transport and communications in line with the country's needs. It also regulates, inspects, and oversees mail and telegraph services.

As per the 2008 edition of the standard, shipping of different dangerous goods items in multi-compartment tanks require labels to be displayed on both sides of each compartment. The updated version of the standard from 2023 explains that the labels need to be displayed only once along the sides of the transport unit if all compartments require the same labels.

Also, the provisions in the 2008 edition describe that if a transport unit contains multiple items having different hazard classes for shipping, the labels should identify the two most dangerous items. This requisite has been eliminated from the updated version as there is no information available on the identification of the two dangerous items from the multiple products. Furthermore, a lithium battery mark is introduced in the updated standard for packages containing defined amounts of lithium-ion cells or batteries.

For a substance in quantities of more than 4,000 kg, the standard will associate with the International Maritime Dangerous Goods (IMDG) code to include UN number labels for multimodal containers transported by sea.

23 standards on dangerous goods transport are being revised by the SICT. The standards which are already published involve standards on transport documents, packaging construction and testing, as well as correct use of packaging.

Bolivia establishes new requirements and procedures to perform activities with controlled chemical substances and strengthen their supervision of them. On April 12 2023, the Plurinational State of Bolivia published Supreme Decree 4911. This decree announces the establishment of the online platform Digital State System ED-6 which is administered by the General Directorate of Controlled Substances. ED-6 aims to give speed, control and efficiency in handling procedures related to the legal use of controlled chemical substances.

The following procedures must be performed through the digital system:

• Registrations, renewal, voluntary disqualification, and rehabilitation of registrations, of natural or legal persons
• Modification of registration data or controlled chemical substances
• Prior authorizations for export
• Prior authorizations for importation
• Previous authorizations for production
• Authorizations for local purchase and transport route sheets
• Extension of validity and modification of authorizations
• Legalizations and certifications
• Laboratory Certificates
• Certifications of homologation of controlled chemical substances and finished products
• Neutralization, destruction, or voluntary delivery of controlled chemical substances
• Presentation of monthly discharge reports
• Other procedures subject to regulation

The procedures will be carried out in the ED-6 System, by physical persons directly, by legal persons through their legal representative or in both cases by attorneys, duly accredited as users.

The requirements of regulations extend to various chemical substances, including but not limited to; benzoyl chloride, carbon tetrachloride, acetyl chloride, ethyl alcohol, and sulfuric acid. To comply with these regulations, companies that handle controlled substances are mandated to register and authorize their use through the digital system.

The deadline for initial registration and authorization is 9 August 2023, and previously registered companies must update their information through the same system by 11 October 2023. It's crucial to adhere to these deadlines to ensure compliance with the relevant regulations and avoid possible penalties or legal ramifications.