GPC Newsletter Aug-2023

Regulatory News

In a recent update, the Government of Canada has informed WTO Members about a delay in the release of the final "Prohibition of Certain Toxic Substances Regulations, 2022." Originally slated for publication in 2023, these regulations are now expected to be made available no earlier than the summer of 2024. 


On May 14, 2022, the Government of Canada introduced the "Prohibition of Certain Toxic Substances Regulations, 2022" (proposed Regulations). This announcement was made via the Canada Gazette, Part I, initiating a 75-day public comment period that ended on July 28, 2022. 

Key Changes 

These proposed regulations were designed to replace the existing "Prohibition of Certain Toxic Substances Regulations, 2012" (current Regulations) on the day when the final Regulations would come into effect. The primary goal of the proposed Regulations was to impose stricter controls on specific categories of per- and polyfluoroalkyl substances (PFASs), as well as two types of flame retardants and related products already under regulation. Additionally, two additional flame retardants and their products were slated for inclusion under these regulations. 

Ongoing Review 

During the public comment period, a significant number of complex and technical comments were received. Authorities are diligently assessing these comments and taking them into consideration in the development of the final Regulations. 

This delay in the publication of the final Regulations underscores the Government of Canada's commitment to ensuring a comprehensive and well-considered approach to the regulation of toxic substances. Stay tuned for updates on this crucial matter. 

On August 3, 2023, Health Canada issued a consumer product recall notice for four cosmetic goods manufactured by the US-based company Yes To due to the presence of plastic microbeads. Microbeads are listed as toxic substances in Schedule 1 of the Canadian Environmental Protection Act (CEPA).

Yes To, a global pioneer in natural skincare products since 2006, is now devoted to sustainability. The company sells fruit and vegetable-based goods manufactured from natural ingredients such as tomatoes, grapefruit, cucumber, watermelon, avocado, and tea tree. 90% of the products are vegan.

The following four products of the Yes To brand are listed in the recall notice. 35,964 units of the products were sold in Canada between July 2018 and December 2022:

  • Grapefruit Daily Facial Scrub

  • Tomatoes Charcoal Detoxifying Daily Cleanser

  • Tomatoes Detoxifying Charcoal Deep Cleansing Scrub

  • Tomatoes detoxifying charcoal deep cleansing scrub CA

Since 2018, the Microbeads in Toiletries Regulation implemented by the Canadian Government bans the manufacturing, importation, and sale of exfoliating or cleansing toiletries using plastic microbeads, as well as non-prescription medications and natural health products. The manufacturing, import, and sale of personal care goods containing plastic microbeads of 5mm (about 0.2 in) or less in size is prohibited. The purpose of the ban is to prevent microplastic particles from contaminating waterways. Health Canada has asked users to cease using the goods immediately and return them to the retailer where they were purchased for proper disposal.  

The European Chemicals Agency (ECHA) has prepared a draft investigation report on carcinogenic, mutagenic and reprotoxic (CMR, cat 1A or 1B) substances that may be present in childcare articles. The purpose of the current investigation is to support the European Commission in the preparation of a restriction to protect children from exposure to CMR 1A or 1B substances in childcare articles.

The consultation on the draft investigation report has started on 23 August 2023. Interested stakeholders can provide their comments on the report and the appendices until 29 September 2023 (23:59 Helsinki time). Comments can be submitted here.

It is intended for interested parties such as childcare article manufacturers, importers or retailers, industry associations, consumer protection associations, testing laboratories, customs, and enforcement authorities. Both EU/EEA and non-EU stakeholders are encouraged to participate. The information submitted will be used to finalise the investigation report that will be sent to the Commission at the end of October.

The Report and Appendices can be viewed under Related Documents in this link:

Information can be submitted confidentially and will be treated as such by ECHA. Any statement, figure or information provided via this call for evidence should be supported with a robust justification, and reference and calculation whenever relevant. Where information is submitted in this call for evidence, but no reference to sources or calculations are made to justify such information, it is unlikely that ECHA will be able take the comments into account.

For any clarifications please contact: Information on the background for above news can be found  here.


The European Committee for Cosmetics and Consumer Health (CD-P-COS) has revised the safety criteria for cosmetic products for young children under the age of 3. The 2nd edition (2023) of safety guidelines includes a chapter on ingredients, aligning exposure calculations with the Scientific Committee on Consumer Safety's Notes of guidance, and updating fluoride use in toothpaste.

The CD-P-COS is leading the Council of Europe's cosmetics activities, preparing standards and policies to enhance consumer health protection. The rapid increase in children's cosmetics has put pressure on market surveillance authorities to report unsafe products via the EU's Safety Gate system. CD-P-COS's technical standards aim to alleviate this burden.

The revised edition of the guide includes the following:

  • New sections on endocrine disruptors and nanomaterials

  • Updated safety margin calculations for cosmetic compounds

  • Updated standards for evaluating the safety of final goods

  • Recommendations for using goods, such as baby wipes, terpenes, sunblock, and fluoride

  • Updated research and governing body references

All consumers of cosmetic items, regardless of age, should be protected from hazardous chemicals and endocrine disruptors. To address any recognized health hazards associated with cosmetics, it is vital to keep in mind that young children are particularly vulnerable to these substances. Cosmetics' appealing packaging and other features may enhance the possibility of poisoning or choking for youngsters who consume them. The Council of Europe Resolution CM/ResAP (2012) urges European governments to ensure that cosmetic products for infants undergo an appropriate safety assessment before being released on the market.

List of substances excluded to be used in infant cosmetic products

  1. Substances of very high concern that are candidates for inclusion in Annex XIV of Regulation (EC) No. 1907/2009

  2. CMRs category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No. 1272/2008

  3. Endocrine disruptors mentioned in Annex 15

  4. Substances that are potent allergens

The European Network of Official Cosmetics Control Laboratories has closely monitored cosmetics in toys-like containers, finding banned ingredients and high allergen concentrations. Consumers should be encouraged to select care products based on their intended use.

On 25 August 2023, the European Chemicals Agency (ECHA) announced that an amendment, Commission Delegated Regulation (EU) 2023/1656, has been made adding 35 additional hazardous chemicals to the EU’s Prior Informed Consent (PIC) Regulation. The amendment enters into force on 15 September 2023 and will apply from 1 November 2023.

Added chemicals

The 35 chemicals that were added to Annex I of the PIC Regulation include 27 pesticides and 8 industrial chemicals. The full list of chemicals can be seen below. These chemicals will require export notification and in addition most of them will also require an explicit consent from the importing country before exports can take place. The IT tool ePIC has been updated accordingly and companies can already start notifying their exports. 



CAS no

EC no


Use limitations**

‘1-bromopropane (n-propyl bromide)





1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich







1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters





1,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear















Bis(2-methoxyethyl) phthalate






























Diisopentyl phthalate





Dipentyl phthalate














































173584-44-6 144171-61-9





























n-pentyl-isopentyl phthalate



































* Sub-category: p(1) — pesticide in the group of plant protection products, p(2) — other pesticide including biocides. i(1) — industrial chemical for professional use and i(2) — industrial chemical for public use.

** Use limitation: sr — severe restriction, b — ban (for the sub-category or sub-categories concerned)


In addition to the 35 new entries to Annex I, four chemicals (triflumuron, cyfluthrin, chlorfenvinphos, and terbufos) that were previously subject only to an export notification, will now also require an explicit consent (i.e. they have been added to Part 2 of Annex I). 

Furthermore, it was decided at the tenth meeting of the Conference of the Parties (COP) to the Rotterdam Convention to include decabromodiphenyl ether and perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Annex III of that Convention. That means that those chemicals are now subject to the PIC procedure under the Rotterdam Convention. Consequently, those chemicals will be deleted from Part 2 of Annex I to Regulation (EU) No 649/2012 (the PIC Regulation) and instead added to Part 3 of Annex I. The entries in Part 3 are subject to the export notification requirement, and additionally to the explicit consent, except where an import response is published in the PIC circular of the Rotterdam Convention, and certain criteria are met.


Prior Informed Consent Regulation

The PIC Regulation (Regulation (EU) No 649/2012) implements the Rotterdam Convention within the EU. It promotes shared responsibility and cooperation in the international trade of hazardous chemicals. It also protects human health and the environment by providing importing countries with information on how to store, transport, use and dispose of hazardous chemicals safely.


It governs the trade of certain hazardous chemicals that are banned or severely restricted in the EU. It places obligations on companies that wish to export these chemicals to non-EU countries or import them into the EU.

The European Commission updates PIC Annex I, which lists the chemicals subject to export notification and explicit consent from the importing country. It now includes 295 entries.

On 24 August 2023, the transition period for the amendment of Annex XVII REACH regarding restriction of diisocyanates ends. The amendment, Commission Regulation (EU) 2020/1149, came into force on 23 August 2020 and included a transition period of 3 years to allow the concerned workforce to undergo the required training.

After the end of the transition period the Restriction establishes requirements for the use and placing on the market of diisocyanates as substances on their own, as a constituent in other substances, or in mixtures for industrial and professional use(s) in concentrations above 0,1% by weight unless the user has successfully completed a training on the safe use of the substance. The training must include instructions for the control of dermal and inhalation exposure to diisocyanates at the workplace and must be conducted by an expert on occupational safety and health. The training must be renewed at least every 5 years. Details of the required training can be found in Regulation 2020/1149 here.

Placing on the market of diisocyanates has already been restricted since 24 February 2022. The requirements are that diisocyanates cannot be placed on the market as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) unless the concentration of diisocyanates individually and in combination is less than 0.1 % by weight and labelled with the information ‘As from 24 August 2023 adequate training is required before industrial or professional use’.

Diisocyanates are classified as respiratory sensitiser category 1 and skin sensitisers category 1. They are mainly used to make polyurethane products, such as foams, sealants, coatings and in the automotive industry.


Restricting the use of diisocyanates is estimated to prevent over 3 000 new cases of occupational asthma a year in the EU.

On 11 August 2023 the European Commission published an amendment, Regulation (EU) 2023/1627, to Annex I of Regulation (EU) No 10/2011 (the Food Contact Plastics Regulation) in the Official Journal of the European Union.

The amendment grants authorisation for the use of bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH) in the production of plastic food contact materials (FCMs) and will come into force on 31 August 2023.


In the amendment DEHCH is added Annex I of Regulation No 10/2011 which establishes a Union list of authorised substances that may be intentionally used in the manufacture of plastic materials and articles intended to come into contact with food.


The authorisation follows a safety assessment adopted by the Panel on Food Contact Materials, Enzymes, and Processing Aids (CEP) under the European Food Safety Authority (EFSA) in December 2019 on the use of DEHCH as a plasticiser in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact with refrigerated or frozen aqueous, acidic and low-alcohol foods.

Based on a scientific study the CEP concluded that DEHCH does not raise genotoxicity concerns and that no adverse effects were observed in the toxicity studies. The CEP, however, expressed an uncertainty regarding the potential for accumulation of the substance in humans. It was therefore concluded that the migration of the substance should not exceed 0.05 mg/kg food and that it should only be used in PVC in contact with foods, for which simulants A (10 % ethanol) and B (3 % acetic acid) are assigned, at room temperature or below.

On 17 August 2023, the new EU Regulation (Regulation (EU) 2023/1542) concerning batteries and waste batteries entered into force and the Batteries Directive (Directive 2006/66/EC) was repealed. In the coming years the European Chemicals Agency (ECHA) will support the European Commission with tasks aiming to make batteries safer.

The development and production of batteries are strategic priorities for Europe in the transition towards clean energy. The global demand for batteries is increasing rapidly and is predicted to have a 14-fold increase by the year 2030. To minimise the environmental impacts of this growth and considering changes in society, new technological developments, markets and the uses of batteries, the European Commission has implemented the new Batteries Regulation. Some of the keypoints of the new regulation are as follows:

  • Continue to restrict the use of mercury and cadmium in batteries.

  • Introduce a restriction for lead in portable batteries.

  • Aim to strengthen the internal market by ensuring a level playing field through a common set of rules.

  • Promote a circular economy.

  • Seek to reduce the environmental and social impacts throughout the entire life cycle of batteries.

ECHA will support the European Commission in the process by:

  • Assisting in preparing a report on substances of concern contained in batteries or used in their manufacturing that have negative impacts on human health, the environment or recycling for safe and high-quality raw materials. It is expected that ECHA will begin its work toward this report in 2024 and present it by 31 December 2027.

  • Preparing, if requested by the Commission, a restriction proposal on harmful substances used in the manufacturing of batteries or present in batteries when they are placed on the market, and in waste batteries in accordance with Annex XV of REACH.

  • Providing an opinion through the committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) on the effectiveness of the restriction proposal in managing the risk and its impact on society.

Some more details on the new Battery Regulation can be found here.

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH is a regulation of the European Union (EU), adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness chemicals industry of the EU. It came into force on 1 June 2007. REACH also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

 In a recent development, the Annex III Inventory of the REACH regulation, which comprises a compilation of substances deemed unlikely to benefit from reduced information requirements, has been officially withdrawn. Under the REACH regulation, companies are permitted to register substances with reduced information requirements, as long as these substances do not meet the criteria outlined in Annex III. Notably, the need to cross-reference the Annex III Inventory during the evaluation process to determine if a substance aligns with the criteria has been eliminated. This adjustment aims to streamline the registration process and enhance efficiency for companies navigating compliance within the framework of the REACH regulation.

 GPC can assist you to meet all your substance-related obligations under EU-REACH, such as full substance assessments, issuance of compliance certificates, and registration of chemicals. For more information, please email us at or book a free consultation meeting here:

On 3 July 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) adopted Opinion on Water-soluble Zinc Salts Used in Oral Hygiene Products (II). Water-soluble zinc compounds are used in oral cosmetics to minimize mouth malodor, tartar, and plaque development. Water-soluble zinc salts are now controlled under Annex III to Regulation (EC) 1223/2009 (Cosmetics Regulation). Comments are accepted until 8 September 2023.

The SCCS assessment is based on overall exposure, which takes zinc in the diet into account. For toothpaste, it suggests a safe dosage of 0.72% for infants and toddlers. For all ages, 0.1% Zn zinc in mouthwash is considered safe.

Since the use of mouthwash is not suggested for children aged 5 and under, no mouthwash exposure evaluation is undertaken for this age group.

Estimated amounts of zinc exposure for both the separate products and aggregated exposures for children (0.5-5 years and 6-17 years) and adults.

Age Group



Daily intake level (mg/day)

Adults (>18 yrs)








Aggregated exposure adults (>18 yrs)




Children (6-17 yrs)









Aggregated exposure children (6- 17 yrs)




Children (0.5-5 yrs)




On 8 August 2023, the EU published Regulation (EU) 2023/1068 in the Official Journal of European Union amending Regulation (EU) 2019/1021 known as the Persistent Organic Polutants (POPs) Regulation. In the amendment perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds are officially listed in Annex I to Regulation (EU) 2019/1021. The amendment comes into force on 28 August 2023.

PFHxS is part of the group of compounds collectively known as per- and polyfluoroalkyl substances (PFASs). It is a used as a surfactant in a variety of industrial and commercial products such as food packaging, stain and water-resistant materials, fire-fighting foams, and paint additives. PFHxS, its salts, and PFHxS-related compounds are listed in Annex A to the Stockholm Convention since June 2022 without specific exemption. Each Party to the Convention is required to prohibit the chemicals listed in Annex A and/or take the legal and administrative measures necessary to eliminate their production, use, import and export. Therefore, Part A of Annex I to Regulation (EU) 2019/1021 which contains a list of the substances listed in the Convention has been amended to include PFHxS, its salts and PFHxS-related compounds. In accordance with Regulation (EU) 2019/1021 the manufacturing, placing on the market and use of substances whether on their own, in mixtures or in articles) listed in Annex I, is prohibited (if no exemptions apply).

The amendment sets the following a limit value for PFHxS, its salts and PFHxS-related compounds occurring as an unintentional trace contaminant in substances, mixtures and articles.

  • ≦ 0.025 mg/kg for PFHxS or any of its salts

  • ≦ 1mg/kg for the individual PFHxS-related compounds or sum of concentrations of all PFHxS-related compounds

  • For the use in firefighting foams where those limit values cannot currently be met, higher concentration limits should be established, subject to review by the Commission no later than 28 August 2026 with a view to lowering the limits.

In the EU, starting from 1 January 2024, all newly submitted Poison Centre Notifications (PCNs) must comply with the harmonized information requirements detailed in Annex VIII to the Classification, Labelling and Packaging (CLP) Regulation. Importers and downstream users of industrial use only mixtures must therefore be aware of the approaching deadline for poison centre compliance.

Industrial-use-only mixtures are exclusively used within industrial premises and remain inaccessible to both consumers and professionals, whether in their end-product form or through any diluted versions achieved via reformulation, such as mixtures within mixtures (MiM). An example of an industrial-use-only mixture (as a final product) could be an automotive paint used only at industrial site and accessible only by industrial end users.

There will be a one-year transitional period. Notifications for industrial-use-only mixtures that are on the market and notified before 1 January 2024 will remain valid until 1 January 2025 or until changes are made to the product (e.g. changes to the mixture composition, toxicological properties, or product identifiers). 

According to Annex VIII to the CLP Regulation, the harmonised information requirements include:

  • the full chemical composition

  • the toxicological information

  • information about the product

  • the unique formula identifier (UFI)

However, when it comes to industrial use mixtures, there is the option of making a "limited submission" where compositional information from the Safety Data Sheet can be used. If this option is used, the notification must include a contact person who can provide around the clock rapid access to the complete compositional details in case of an incident.

PCNs can be prepared and submitted to the European Chemicals Agency (ECHA) using the International Uniform Chemical Information Database (IUCLID). More information can be found at ECHA’s Poison Centre Website:

On 19 July 2023, the European Commission amended Regulation (EC) No 1223/2009 of the European Parliament. The new regulation will prohibit the use of 31 carcinogenic, mutagenic, or toxic for reproduction (CMR) substances in cosmetic products. The amendment comes into force on 9 August 2023 and is applicable from 1 December 2023.

The EU Commission wants to ensure legal certainty and high human health protection. All CMR substances would be included in the prohibited substances list of Regulation (EC) No 1223/2009 (Annex II) and deleted from the restricted or allowed substances lists. If conditions are met, the lists of restricted or allowed substances would be amended accordingly.

The legislation, officially published in the EU Journal on 20 July, adds the compounds to the list of restricted substances in Annex II of the Cosmetic Products legislation. The published regulation is available here.

Annex II to Regulation (EC) No 1223/2009 is amended as follows:

Replacement of Reference No. 1024 as follows:


Sr. No.

Reference No.

Substance name



2-ethylhexanoic acid and its salts with the exception of those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008

The following substances are prohibited:


Sr. No.

Reference No.

Substance name



Ammonium bromide



Dibutyltin bis(2-ethylhexanoate)



Dibutyltin di(acetate)



Tellurium dioxide



Barium diboron tetraoxide



2,2-dimethylpropan-1-ol,tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol






4,4’-sulphonyldiphenol; bisphenol S






Quinoclamine (ISO); 2-amino-3-chloro-1,4-naphthoquinone



Perfluoroheptanoic acid; tridecafluoroheptanoic acid



methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate; valifenalate



6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts



6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid



6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid



Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione



1,3,5-triazine-2,4,6-triamine; melamine



Fluopicolide (ISO); 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide



N-(2-nitrophenyl)phosphoric triamide



N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide; isoflucypram



Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide [≥ 78 % syn isomers ≤ 15 % anti isomers relative content]; isopyrazam



Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents]






2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate;



Pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate



N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid); Pentetic Acid (INCI)



Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate; Pentasodium Pentetate (INCI)



Acetamiprid (ISO); (1E)-N-[(6-chloropyridin-3-yl)methyl]-N’-cyano-N-methylethanimidamide; (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine



Pendimethalin (ISO); N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene



Bentazone (ISO); 3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide

The commission has also updated the substances list in CLP Annex VI during the 18th adaptation to technical progress (ATP) in May 2023.

On 24 August 2023, the United Kingdom’s Health and Security Executive (HSE) notified the World Trade Organization (WTO) on the amendment of the Great Britain mandatory classification and labelling list (the GB MCL list), following review, by introducing new and revised entries for the mandatory classification and labelling of 26 hazardous chemical substances. The last day for comments is 60 days from the notification date.

Classification in Great Britain

Substances and mixtures placed on the GB market must be classified and labelled in line with the GB Classification, Labelling and Packaging (CLP) Regulation. There are two kinds of classification:

  • Mandatory classification stands for a classification that has been made legally binding within Great Britain. It aligns with the 'harmonised classifications' established under EU CLP. The mandatory classifications and the accompanying hazard labelling (MCL) are listed in the GB mandatory classification and labelling list (GB MCL list). In cases where a substance possesses an MCL for some or all hazard classes, suppliers to the GB market are obligated to implement this classification.

  • Self-classification involves the supplier collecting and assessing all accessible data, subsequently matching it against the classification criteria. Self-classification applies to all mixtures, and to substances which do not have a mandatory classification. Substances which do have a mandatory classification are still subject to self-classification for any hazard classes not covered by that mandatory classification.

GB MCL Technical Reports

Links for the GB MCL technical reports for the 26 hazardous substances can be found here. A GB MCL technical report is an independent scientific evaluation of the information submitted under the GB MCL process or as part of the EU harmonised classification and labelling process. The reports outline if there is adequate scientific evidence to support a new or revised GB MCL of a substance. 

This batch of GB MCL technical reports relate to substances for which the Committee for Risk Assessment (RAC) published a RAC Opinion under Article 37(4) of EU CLP during 2022 and 2023, based on information submitted under the EU CLP Regulation. The scientific information supporting the RAC Opinion is evaluated under the GB MCL system. 

Next steps

The amendment is expected to be adopted in the first quarter of 2024 and is expected to become mandatory by the third quarter of 2025. 

The next batch of technical reports is expected to be published in late November 2023. CLP ebulletin alerts will be issued when technical reports are published on the HSE website. 

On 14 August 2023, the UK’s Office for Product Safety and Standards (OPSS) published a call for submission of any scientific information relevant to the safety assessment of nanomaterials used in cosmetics.


Details of the call

Any interested parties, including academia, manufacturers of cosmetic products / raw materials, and consumer associations are invited by the OPSS to submit any scientific information relevant to the safety assessment of the following nanomaterials used in cosmetics.

  1. Platinum (nano)

  2. Copper (nano)

  3. Silver (nano), colloidal silver (nano)

  4. Gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano)

  5. Silica (nano), hydrated silica (nano), silica silylate (nano), silica dimethyl silylate (nano)

  6. Lithium magnesium sodium silicate (nano)

  7. Hydroxyapatite (nano)

Any scientific data submitted for the safety assessment must include all relevant elements as prescribed in the Scientific Committee on Consumer Safety Guidance on the Safety Assessment of Nanomaterials in Cosmetics.

The deadline for submission of data on silica (nano), hydrated silica (nano), silica silylate (nano), and silica dimethyl silylate (nano) is 27 June 2025. Data on all other substances must be submitted by 22 December 2023. Relevant data can be submitted by email to



Article 16 of the UK Cosmetics Regulation mandates the prior notification of cosmetic items that incorporate nanomaterials to the Secretary of State, a minimum of six months before being placed on the market. This obligation can be fulfilled through the utilization of the Submit Cosmetic Product Notification (SCPN) portal.

When dealing with nanomaterials not listed in Annexes IV, V, and VI, these notifications must include additional data on the safety of the nanomaterial for use in cosmetic products.


Notes regarding the call

The Scientific Advisory Group on Chemical Safety (SAG-CS) will use 70 kg as their default bodyweight assumption for adults in new safety assessments. This aligns with other UK groups, carrying out chemical risk assessments across a range of sectors that have agreed that a default adult body weight of 70 kg is representative of the UK adult population. 


The OPSS is asking for original study reports and literature in full to be submitted for all data relied upon in the safety assessment. This is particularly important for the pivotal studies, those which support the critical No Observed Adverse Effect Level (NOAEL) and point of departure and the dermal absorption value.

The office takes the examination of data very seriously and commits to subjecting all provided information to independent scientific review. Cosmetic products available to consumers must be safe for human health. Following the conclusion of the review process the OPSS will take the necessary action to ensure the safety of consumers. This could include but is not limited to prohibiting or restricting specific ingredients if a risk to human health is identified.

On August 14, 2023, the Office for Product Safety and Standards (OPSS) of the United Kingdom issued a notification to submit any scientific information relevant to the safety assessment of cosmetic ingredients in the list below. Interested parties, including academia, cosmetic product manufacturers, and producers of the substances can submit the information before 15 December 2023. 

List of Chemicals 


Sr. No. 

Chemical Name 




CAS 3380-34-5 



CAS 101-20-2 


4-Methylbenzylidene camphor 

CAS 36861-47-9 / 38102-62-4 


Salicylic acid 

CAS 69-72-7 



CAS 94-26-8 



CAS 99-76-3 


The OPSS wants to evaluate the safety of these chemicals in cosmetic products due to their potential endocrine-disrupting properties. Any pertinent data to support the safety and exposure estimates for children and expectant women should be included if components are used in products that are likely to be used by these groups of people. 


Any scientific data submitted for the safety assessment must include all relevant elements as prescribed in the Scientific Committee on Consumer Safety Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation. 


All data used in the safety evaluation must be submitted in full, original study reports and literature. This is crucial for pivotal studies that support the key No Observed Adverse Effect Level (NOAEL) and point of departure as well as the dermal absorption value. The analysis of data is a major undertaking for OPSS, and they will make sure that any material provided to them is subjected to an impartial scientific study. Emails with pertinent information should be sent to  



The Scientific Advisory Group on Chemical Safety (SAG-CS) will use 70 kg as the default body weight for adults in new safety assessments, aligning with other UK groups like the UK Committee on Toxicity of Chemicals.  

The Office for Product Safety and Standards processes information in compliance with UK General Data Protection Regulation (GDPR) and Data Protection Act 2018 (DPA 2018) regulations. Personal data collected is securely held and used for administrative purposes. 

On 9 August 2023, the British Health and Safety Executive (HSE) issued an e-bulletin inviting companies to notify the HSE of exports of chemicals in the Great Britain Prior Informed Consent (PIC) List anticipated to occur in 2024.

PIC – Prior Informed Consent

The Prior Informed Consent (PIC) regime in GB regulates the export and import of certain hazardous chemicals listed in the PIC List. The HSE is the PIC Designated National Authority (DNA) for Great Britain and administers the GB PIC regime including the export notification system and providing information on GB PIC.

The GB PIC Regulation requires that the initial export of a listed chemical to any country, in any calendar year, to be notified to the HSE at least 35 days before the planned date of export. This includes the transfer of a listed chemical from Great Britain to Northern Ireland.

How to apply for Export Notifications

  • Complete a GB PIC export notification form

  • Send completed forms to with the following details in the subject line of the email: GB PIC - notification - company name - chemical/mixture - importing country name - 2024

  • Attach only one export notification form and accompanying safety data sheet (SDS) to each email.

  • In addition to an SDS in English, an SDS in the official language of the importing country should be provided if available, or in one of its principal languages. 

How to apply for Special Reference Identification Numbers

When exporting PIC chemicals for the purpose of research or analysis in quantities of 10 kg or less per exporter, per year and per importing country, Special Reference Identification Numbers (RINs) are required. A Special RIN is also required where an importing country has waived its right to receive an export notification and has notified a positive import response under the Rotterdam Convention for the chemical being exported. 

Special RIN requests for 2024 can now be submitted as follows:

  • Complete a Special RIN request form

  • Send the completed forms to with the following details in the subject line of the email: GB PIC – Special RIN request - company name – chemical/mixture – importing country name – 2024

For exports of PIC chemicals to the EU, each Special RIN covers exports of up to 10kg of the substance for research and analysis purposes to each EU importing country.

Background – The Rotterdam Convention

The UK is a Party to the Rotterdam Convention on the Prior Informed Consent (PIC) procedure for certain hazardous chemicals and pesticides in international trade. The aims of the Rotterdam Convention are:

  • To promote shared responsibility and cooperation in international trade of listed hazardous chemicals - through export notifications and the pic procedure.

  • To protect human health and the environment by providing countries with information on how to store, transport, use and dispose of hazardous chemicals safely.

The PIC Regulation implements the Rotterdam Convention in GB but goes further by applying the requirements to chemicals that are banned or severely restricted in GB not just those listed in the Convention. You can find further information on the Rotterdam Convention website, including the latest PIC circular.

On 18 August 2023 the Health and Safety Executive (HSE) the United Kingdom (UK) issued an ebulletin listing 15 active substance that must be phased out from biocidal products on the market in Great Britain (i.e. England, Scotland, and Wales). The decision comes after the active substances have been evaluated under the Great Britain Biocidal Products Regulation (GB BPR).

Biocidal products containing the active substances listed in the table below will no longer be approved in the product types listed in the table. Such biocidal products can no longer be supplied in GB after 15 August 2024 and will be prohibited to use in GB after 15 February 2025. Companies must ensure to remove affected products from the GB supply chain by 15 August 2024. New treated articles containing active substances listed in the table cannot enter the supply chain or be imported into GB after 11 February 2024.


Active Substance

CAS no

EC no

Product type




13: Working or cutting fluid preservatives



2,2-dibromo-2-cyanoacetamide (DBNPA)



13: Working or cutting fluid preservatives













19: Repellents and attractants



Amines, C10-16-alkyldimethyl, N-oxides



04: Food and feed area






09: Fibre, leather, rubber and polymerised materials preservatives

Capsicum annuum, ext. (Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Capsicum annuum, Solanaceae)



19: Repellents and attractants



Capsicum oleoresin (Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerisation products of these terpenes.) (Capsicum frutescens, Solanaceae)



19: Repellents and attractants



Carbon dioxide



19: Repellents and attractants



Dialuminium chloride pentahydroxide



02: Disinfectants and algaecides not intended for direct application to humans or animals



Eucalyptus citriodora oil and citronellal, hydrated, cyclized



19: Repellents and attractants

Malt, ext. (Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hordeum, Gramineae)



19: Repellents and attractants




09: Fibre, leather, rubber and polymerised materials preservatives

11: Preservatives for liquid-cooling and processing systems

Peroxyoctanoic acid



02: Disinfectants and algaecides not intended for direct application to humans or animals


03: Veterinary hygiene

04: Food and feed area

Reaction mass of (6E)-N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnon-6-enamide and N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnonanamide



19: Repellents and attractants

Reaction mass of titanium dioxide and silver chloride



01: Human hygiene

02: Disinfectants and algaecides not intended for direct application to humans or animals


06: Preservatives for products during storage

07: Film preservatives

08: Wood preservatives

09: Fibre, leather, rubber and polymerised materials preservatives

Reaction products of aluminium trihydroxide and hydrochloric acid and aluminium and water



02: Disinfectants and algaecides not intended for direct application to humans or animals



Silver, as a nanomaterial



02: Disinfectants and algaecides not intended for direct application to humans or animals


04: Food and feed area

09: Fibre, leather, rubber and polymerised materials preservatives

Sodium N-(hydroxymethyl)glycinate



06: Preservatives for products during storage




09: Fibre, leather, rubber and polymerised materials preservatives



After Brexit an independent biocides regulatory regime, GB BPR, is now in operation in Great Britain (England, Scotland and Wales). The existing EU Biocidal Products Regulation (EU BPR) was copied into GB law and amended to enable it to operate effectively in GB. This means that most aspects of EU BPR continue in the same way under GB BPR that came into force at 11pm on 31 December 2020.

On 28 June 2023 the Indian Ministry of Power published a notice in the Gazette of India notifying the release of the Carbon Credit Trading Scheme, 2023. The Scheme came in to force on the day of publication in the Gazette. 

The plan outlines each institution's specific responsibilities for putting the Indian carbon credit trading plan into action. Carbon credits certificates (CCCs) will be awarded to required entities that achieve their greenhouse gas emission objectives. Those that cannot make up the difference by buying carbon credit certificates.  

Below are the respective duties of each of the institutions. 

Governance: National Steering Committee for Indian Carbon Market 

The National Steering Committee for Indian Carbon Market was created when the Indian carbon market was formed. Representatives from the Ministry of Power, Ministry of Finance, Ministry of New and Renewable Energy, Bureau of Energy Efficiency, and several other ministries and organizations will sit on the committee. The Committee has the following functions: 

  • Observe how the Indian carbon market operates. 

  • Make recommendations to the Bureau of Energy Efficiency for the development of carbon market regulations and processes, greenhouse gas emission objectives, rules for selling carbon credit certificates outside of India, etc. 

  • Determine the requirements and format for submissions, the validity of the CCC, the floor price, the forbearance price, and other associated compliance measures. 

Administrate: Bureau of Energy Efficiency  

As the administrator the Bureau of Energy Efficiency (BEE) oversees the following functions: 

  • Determine which industries have the most potential to reduce greenhouse gas emissions. 

  • Create targets and a compliance trajectory for entities. 

  • Distribute CCCs 

  • Set CCC achieving criteria for each industry by conducting studies. 

Registry: The Grid Controller of India 

The Grid Controller of India Limited shall be the Registry for the Indian carbon market. The Registry shall oversee the following functions as determined by the Central Government from time to time: 

  • Keep a database of registration of CCC-related organizations 

  • Keep track of CCC transactions. 

  • Assist in the development of an information technology platform for maintaining a database of CCCs. 

Regulator: Central Electricity Regulatory Commission 

The Central Electricity Regulatory Commission shall be the regulator for the trading activities under the Indian carbon market. The regulator shall perform the following: 

  • Regulate CCC trading-related issues 

  • Regulate CCC trading frequency 

  • Provide market monitoring, and take the appropriate precautions to avoid fraud or distrust. 

Furthermore, the Bureau of Energy Efficiency shall constitute one or more Technical Committees for different areas as required under compliance mechanisms for the purpose of the Scheme. 

 The full text of the Carbon Credit Trading Scheme 2023 can be found here

On 6 July 2023 the Bureau of Indian Standards (BIS) published a draft revised standard for Glauber salt (sodium sulphate, decahydrate). The last date for comments is 7 September 2023. 

In 1950, the BIS published a draft for Glauber salt involving the maximum acceptable limits for some heavy metals.  

Glauber salt also known as mirabilite is used in textiles, glass, paper and pulp, dyestuff, leather, and metallurgical industries. In these sectors, it is for example used in the manufacture of plate and sheet partially glass, it serves as an agent to promote even distribution of dye of common salt in curing hides, and is also used for separation of nickel from copper. 

The draft standard was eventually revised in 1972. The first revision involves the limit values for sodium sulphate and zinc.  

  • For sodium sulphate the defined minimum limit was 98.5 percent. 

  • For zinc: the maximum limit was given to be 0.4 percent.  

The current second revision involves test methods for chloride and iron determination. The draft consists of following two annexes: 

  • Annex A: provides method of testing for Glauber salt 

  • Annex B: contains details on sampling of Glauber salt 

Also, a subsection for packing and marking is mentioned in the draft. The product must be marked with the BIS standard mark and the packages must be marked with the following details: 

a) Name and grade of the material; 

b) Net weight of contents;  

c) Year of manufacture;  

d) Manufacturer’s name and/or his recognized trade-mark, if any; and  

e) Batch number to enable the lot of manufacture to be traced from records 


Further details on the methods, packing and marking can be found here: 

The Ministry of Environment and Ecology of China (MEE) has called for public information on long-chain perfluoro carboxylic acids’ (LC-PFCAs) salts and related compounds and medium chain chlorinated paraffins (MCCPs). 

According to the notification, Stockholm Convention expressed that long term persistent organic pollutants (POP) has detrimental effects to environment and human health. In the attachments of the Convention, there are thirty-four categories of chemical substances which are classified as POPs. Ahead of the 19th Convention committee’s assessment which is expected to be opened in October, MEE solicits information on LC-PFCAs and MCCPs. The deadline for the submission of information is 27th August. 

MEE requests information on the production, use, import, export, substitutes and alternative technology of the above two substances within China. This includes information on: 

  • production and usage conditions, such as volume and usage purpose; and 
  • the situation of substitutes or substitute technologies such as on their introduction, costs and effects. 

The POPs Review Committee (POPRC) published draft risk management evaluations of LC-PFCAs and MCCPs in June, recommending that both be added to Annex A of the convention. This would ban their production, use, import and export. The committee is due to discuss the draft evaluations at the October meeting. For more information regarding POP management in China, please contact GPC via for help.

The National Institute of Chemical Safety (Director Park Bong-kyun) formed a consortium for handling facility standards with experts, industries, and civil society to improve the standards of hazardous chemical handling facilities and held a launching ceremony on August 18, 2023, at the National Institute of Chemical Safety. 


The expert consultative body was promoted to prepare for the revision of 15 types of handling facility standards, including the "Notification on the Installation and Management of Hazardous Chemicals Manufacturing and Use Facilities." 


Since early July, the National Institute of Chemical Safety has received recommendations for 10 participants in the expert consultative body from inspection agencies, academia, industry, and civil society. 


The consultative body consists of a total of 15 members, including 5 ex officio members, including the Ministry of Environment's Chemical Safety Division, 3 experts from inspection institutions, 3 experts recommended by industry, and 4 experts recommended by academia and civil society recommendations. 


The expert consultative body will operate until the end of 2024, and discussions will be held at least once a month to prepare standards for handling facilities considering the level of hazard and risk of chemicals. 


The consultative body will discuss technical standards that can minimize the occurrence and damage of chemical accidents, detailed items of facility standards according to acute, chronic, and ecological hazards, and handling facility standards according to physical risks. 


The first discussion, which followed the inauguration ceremony, had time to share the "direction of reorganization of toxic substance designation management system and handling facility standards" and the current status of implementation. 


Based on the discussion of the consultative body, the National Institute of Chemical Safety will prepare a standard notice for manufacturing, use, and storage facilities by December 2023 and announce it at the Chemical Safety Policy Forum. 

On August 1st, 2023, the National Institute of Environmental Research (NIER) in South Korea partially revised and notified the Notice of Designation of Toxic Substances, in accordance with Article 2(6) and Article 20 of the 「Act on the Registration and Evaluation of Chemicals」 and Article 2(2) of the 「Chemical Substances Control Act」 and Article 2 of the Enforcement Decree of the same Act. 

Three highly hazardous chemicals (CAS 37348-84-8, CAS 932384-12-8, CAS 95-46-5) were added as toxic substances under K-REACH. 

The details of the substances are as follows: 

  1. Cobalt manganese nickel oxide (CAS 37348-84-8) and mixtures containing 0.1% or more. 

  1. Silica gel reaction products with chromium oxide (CrO3) and ethoxydiethylalumium (CAS 932384-12-8) and mixtures containing 10% or more of the same. 

  1. 1-Bromo-2-methylbenzene (CAS 95-46-5) and mixtures containing at least 25% thereof. 

Starting this August, the Ministry of Environment in South Korea is introducing a preliminary review system to expedite the completeness review period conducted by the National Institute of Environmental Research. 

1. This system is voluntary and not governed by the Chemical Product Safety Act. It is not included in the statutory review period and can be applied for voluntarily. 

2. The preliminary review period lasts a maximum of 5 days from the day after the request, with only one preliminary review allowed per application. 

3. After the preliminary review, the reviewed items must be confirmed, supplemented, and submitted to the Chemp system before the formal approval process can begin. 

4. The content of the preliminary review is limited to the completeness of the application and some of the required submissions. 

5. The preliminary review period is planned to remain in operation until further notice. However, it may be temporarily suspended in the event of a substantial influx of applications. 


The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) takes part in the WNT (Working Group of the National Coordinators for the Test Guidelines Programme) meeting that is held at the OECD headquarters in Paris, France from April 24 to 29. It participates in the deliberation and approval of OECD guidelines and presents the current status of the liver organoid-based toxicity assessment (complex collections of cells that are three-dimensional tissue cultures derived from stem cells or cells of organ origin. Organoids replicate the structure and function of real organs. They can be used in various areas such as safety evaluation, efficacy evaluation, and the development of treatment) methods developed in Korea.

Japan recently discovered sodium aluminate dioxide (CAS number: 1302-42-7) in some imported goods that included sodium aluminate (CAS number: 11138-49-1). According to an announcement dated 19 July 2023, from the Ministry of Health, Labour and Welfare (MHLW) in accordance with the Poisonous and Deleterious Substances Control Law (PDSCL), manufacturer, or marketers of items proven to contain aluminium sodium dioxide are required to register as poisonous and deleterious substance operators by 31 October 2023.

On 1 July 2018, the MHLW announced sodium aluminate dioxide as a deleterious substance under the Poisonous and Deleterious Substances Control Law (PDSCL). If a company engages in products containing sodium aluminate, they must notify the MHLW and are subject to requirements such as registration, provision of safety data sheets (SDSs), proper labelling and packaging. With these measures, the use of items containing sodium aluminate dioxide will be regulated in order to protect public health and the environment.

The government will continue to strengthen the regulation of deleterious substances to ensure that chemicals are used properly and handled safely.

On 21 July 2023, the Australian Department of Climate Change, Energy, the Environment and Water opened consultations on the proposed scheduling decisions for perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorohexane sulfonate (PFHxS), and pentachlorobenzene (PeCB) under the Industrial Chemicals Environmental Management Standard (IChEMS). The chemicals are all Persistent Organic Pollutants (POPs) included in the Stockholm Convention, which are likely to cause serious or irreversible harm to the environment if not properly managed. As a party to this international treaty, Australia invites the public to make a submission on these proposed scheduling decisions and risk management measures. The consultations are open for feedback until 1 September 2023 and submissions can be made here.

IChEMS is a national approach that aims to efficiently managing chemical usage, storage, handling, and disposal. By establishing standardized environmental protocols for handling industrial chemicals, IChEMS streamlines the process for industries to opt for less hazardous alternatives. Under IChEMS chemicals will be listed on the IChEMS Register in one of seven schedules based on their risk characteristics to provide information on their relative environmental risk. The IChEMS Register will also include risk-proportionate controls that should be applied to protect the environment. Uses of industrial chemicals that pose greater risks to human health and the environment will have tighter controls.

In the IChEMS Register, Schedules 6 and 7 list the industrial chemicals with the greatest environmental concern, e.g. chemicals that are persistent, bio-accumulative and toxic such as POPs. All uses of chemicals in Schedule 6 and 7 will be phased out except for essential uses. Schedules 2 to 5 list industrial chemicals of intermediate concern for the environment. They have controls that are proportionate to the type and level of risk. Schedule 1 lists the industrial chemicals of lowest concern.

If adopted, the proposed Schedule 7 decisions for PFOA, PFOS, and PFHxS will apply from 1 July 2025. For PeCB, the proposed scheduling decision will apply from July 1 of 2024.

The acting President Geraldo Alckmin has signed a decree on the 24th of this month, reestablishing a beneficial tax regime. This development marks a pivotal step towards revitalizing a sector that serves as a central point for the nation's industrial production.

The decree pertains to the revival of the Special Regime for the Chemical Industry (Reiq), which extends tax exemptions to the sector. By bringing back this specialized regime, the Brazilian government aims to enhance the competitive landscape for chemical businesses, which play a pivotal role in generating both direct and indirect employment opportunities. Notably, the chemical industry accounts for a substantial 11% of the country's industrial GDP, a figure underscored by data from the Brazilian Chemical Industry Association (Abiquim).

Scheduled for publication in the Federal Official Gazette on the 25th, this decree is set to redefine the trajectory of the chemical industry. "This sector plays a strategic role in the neo-industrialization initiative and the overall fortification of the industry. Reiq stands as a crucial driver for market competitiveness, job creation, and income generation," remarked President Alckmin.

However, the impact of this decree transcends mere tax exemptions. In addition to restoring previous tax conditions, the new legislation introduces supplementary credits for companies willing to invest in expanding their production capacities or embarking on the establishment of new plants, particularly those harnessing natural gas for fertilizer production.

Established in 2013, Reiq holds the key to enhancing the chemical industry's resilience. It entails the exemption of PIS/Cofins taxes on core products pivotal to the first- and second-generation petrochemical domain. The resulting downstream products encompass an array of essential goods, including fertilizers, active medicinal ingredients, plastics, fibers, rubbers, paints, and inputs for the food and beverage sector. By mitigating cost disparities between local chemical enterprises and their global counterparts, this scheme bolsters the industry's competitive prowess on a global scale.

A comprehensive study conducted by the esteemed Getúlio Vargas Foundation (FGV) in 2021 underscores the profound impact of Reiq. The benefits of this regime cascade beyond the confines of the chemical industry, permeating the entire Brazilian economy. The study revealed an upswing in revenue, heightened productivity, and the preservation of employment opportunities. Intriguingly, projections from the study hinted at the possibility of an annual productivity plunge ranging from R$2.7 billion to R$5.7 billion within the sector if the benefits were to be rescinded.

Furthermore, the study sheds light on Reiq's potential to inject up to R$5.5 billion into the GDP, coupled with a yearly influx of no less than R$2 billion in tax revenue. These numbers underscore the substantial economic gains this specialized tax regime can usher in.

The newly signed decree, however, comes with certain commitments. Chemical plants and industries are expected to forge formal agreements with the Special Secretariat of the Federal Revenue of Brazil, encompassing various stipulations. These commitments encompass compliance with occupational health and safety regulations, adherence to environmentally restorative actions, maintenance of fiscal regularity, procurement of verified emissions reductions certificates, and sustaining workforce levels equivalent to, or exceeding, those present on January 1, 2022.

As this rejuvenated tax regime takes center stage, a vigilant eye will be cast on its implementation. The meticulous oversight of the scheme will be undertaken by various entities, including the Secretariat for Industrial Development, Innovation, Trade, and Services (SDIC), operating in synergy with the Federal Revenue Service, the Ministry of Labor and Employment, and the Ministry of the Environment and Climate Change.

The Brazilian Health Regulatory Agency (Anvisa) has approved a regulation that allows the use of the Single Import Declaration (Duimp) as an alternative for the importation of goods and products subject to Anvisa's non-automatic licensing approval within the Siscomex system. The decision was made unanimously during the public meeting of the directors on August 2nd.

The use of Duimp and other modules available on the Single Foreign Trade Portal will contribute to a more efficient health control of imports, in addition to avoiding the need to submit required documents to all relevant foreign trade agencies. As a result, a significant reduction in costs for the regulated sector in administrative activities and storage time is expected. For instance, the latter directly affects the efficiency of national and international logistics chains.

Outlined below are the primary components of the new RDC:

Understanding Duimp and Its Applicability The Duimp serves as a gateway for importing goods and products that require ANVISA's approval through the non-automatic licensing process within the Integrated Foreign Trade System (Siscomex). This mechanism offers an alternative route for the importation of items that are subject to health scrutiny under non-automatic licensing within Siscomex. With the introduction of the new RDC, the incorporation of import approval via Duimp for various product categories requiring health oversight will be introduced gradually. The specific list of products and the rollout timeline will be announced on the official websites of both ANVISA and Siscomex in the days to come.

Licenses, Permits, Certificates, and Other Essential Documents (LPCO) Utilizing Duimp for imports necessitates adhering to ANVISA's prerequisite for obtaining licenses, permits, or other essential documents, which must be registered using the LPCO module on the Single Foreign Trade Portal. Importers are obligated to ascertain the necessity for presenting LPCO and securing ANVISA's approval before initiating the Duimp registration process.

Transition Phase and Flexibility ANVISA has stipulated a transitional phase during which importers can opt to use Duimp or maintain the traditional import procedure via the Siscomex Import License. This transitional period will remain in effect until the full migration of import processes to the Single Foreign Trade Portal is finalized.

Gains for the Regulated Sector This pivotal shift carries significant advantages for the sector as it entails:

(i) Streamlining import-related health checks, as all pertinent import process data will be consolidated within the Single Foreign Trade Portal.

(ii) Diminishing the requirement to furnish mandatory information and documents to various foreign trade regulatory bodies, thereby enhancing risk management as a primary operational focal point.

As a result, substantial cost reductions are anticipated within the sector, particularly in terms of administrative functions associated with the import process and the duration for which products are stored prior to completion of the importation procedure.

ANVISA has taken a significant step toward ensuring transparency and consumer safety within the personal care product industry. With the introduction of a new Normative Instruction, ANVISA is set to regulate the inclusion of declarations of new formulations on the labeling of personal hygiene products, cosmetics, and perfumes when formula modifications occur. 

Outlined in Instruction No. 243, this new measure mandates manufacturers to prominently display the term "new formula" on the labels of reformulated sanitizing products falling under ANVISA's regulatory purview, for a stipulated period of at least 90 days. The prescribed phrasing should be rendered in a bold, capital-letter font with a minimum height of 1 mm, sharply contrasting with the label's background color. 

Moreover, labels must also incorporate the phrase "new formula" in instances where alterations to the product entail revisions in any of the following aspects: Stated concentration, usage instructions, precautionary or advisory measures and promised benefits of use 

Scheduled for implementation on the 18th of August, this update builds upon a resolution from April that originally established labeling and prerequisites for sanitizing products boasting antimicrobial attributes. 

In a separate development, ANVISA is actively soliciting input from the public regarding a proposition that seeks to modernize the prerequisites governing classification, labeling, and packaging of personal hygiene products, cosmetics, and perfumes. Interested parties are encouraged to submit their comments prior to the looming deadline of the 18th of August. 

The new Normative Instruction aligns with ANVISA's overarching goal of ensuring consumer safety and enhancing transparency within the personal care product sector. By requiring clear and prominent declarations for modified products, ANVISA intends to empower consumers to make informed choices while promoting responsible practices within the industry. 

In a significant move that underscores Brazil's commitment to consumer safety and the regulation of cosmetic products, the National Health Surveillance Agency of Brazil (ANVISA) has introduced new measures that impact the personal care industry. As of August 11, 2023, ANVISA's Resolution RDC 806/2023 has come into effect, ushering in changes to the list of substances that are prohibited in personal hygiene products, cosmetics, and perfumes. Notably, the updated resolution includes two prominent substances, climbazole and zinc pyrithione, which are now prohibited in cosmetics within Brazil.

Climbazole, a chemical recognized for its use in anti-dandruff agents, has been subjected to stringent regulations. The new resolution dictates that cosmetic products cannot contain climbazole in concentrations exceeding 2%. Similarly, zinc pyrithione, a preservative commonly employed in cosmetic formulations, is now limited to a maximum concentration of 1% in cosmetic products.

The implementation of these new regulations necessitates swift action from cosmetics manufacturers and producers. Businesses operating within the cosmetic industry in Brazil must fully comply with the stipulations laid out in the resolution by August 11, 2024. This compliance deadline serves as a clear indication of ANVISA's commitment to ensuring that the personal care products available to consumers meet the highest safety standards.

ANVISA's decision to update its list of prohibited substances was driven by a desire to align with international standards and best practices. The updated resolution, RDC 806/2023, is an evolution of a 2021 regulation, and it also incorporates the Mercosur technical regulation GMC 35/22. This technical regulation, shared by the four Mercosur member countries, defines the permissible substances for use in personal hygiene products, cosmetics, and perfumes. ANVISA's integration of these guidelines demonstrates its dedication to harmonizing with regional and global standards, fostering a safer environment for consumers.

It's worth noting that both climbazole and zinc pyrithione have been subjects of regulatory attention and scrutiny in various parts of the world. Within the European Union (EU), zinc pyrithione's use in cosmetic products was officially prohibited as of March 2022. This EU regulation reflected a commitment to consumer safety and aligning with scientific findings concerning this particular substance. Additionally, climbazole, while not completely banned in cosmetics in the EU, was restricted for use in new cosmetic products as of 2019. Furthermore, it has been under evaluation due to its potential classification as an endocrine disruptor—a classification that underscores the importance of its careful regulation.

ANVISA's decision to include climbazole and zinc pyrithione in its list of prohibited cosmetic substances reinforces its mission to safeguard consumers' health and well-being. By setting specific concentration limits and compliance deadlines, the agency is driving manufacturers to reevaluate their formulations and ensure that their products are in line with the new regulatory framework. This move not only benefits consumers by guaranteeing the safety of cosmetic products but also supports the broader personal care industry by promoting responsible manufacturing practices.

In a significant move towards environmental sustainability, Mexico's Ministry of Environment and Natural Resources has taken a proactive stance by introducing a draft technical standard aimed at regulating the emissions of volatile organic compounds (VOCs) in production processes and auxiliary services. Published on July 17th, this standard signifies a crucial effort to curb pollution and mitigate the adverse effects of VOC emissions on both human health and the environment.

VOCs are a diverse group of carbon-based chemicals that can evaporate into the air and pose a significant threat to air quality. They are emitted from a range of sources including industrial processes, vehicle exhaust, and the use of solvents and paints. Once released into the atmosphere, VOCs can contribute to the formation of ground-level ozone and smog, both of which have been linked to respiratory issues and other health concerns.

The newly proposed draft standard lays out a comprehensive framework that industries operating within Mexico would need to adhere to, emphasizing the importance of reducing VOC emissions to safeguard public health and the environment. The heart of this standard lies in establishing annual threshold limits for various sectors operating in the country. These limits, measured in tonnes, would serve as a clear metric for industries to gauge their emission levels against.

However, merely setting limits is not the only aspect of the standard. The proposed framework goes beyond quantitative restrictions and delves into requiring industries to provide a comprehensive set of information to regulatory authorities. This information includes the list of equipment or activities emitting VOCs, technical specifications, functionality within the production process or auxiliary service, annual operating hours, and the list of solvents used along with their detailed chemical information.

Moreover, the draft standard acknowledges the importance of transparency and accountability. Industries falling within the ambit of this regulation would need to maintain an operations and maintenance log that documents daily and annual consumption of VOCs. These logs not only ensure consistent tracking of emissions but also serve as tangible records for monitoring compliance over time.

One notable aspect of the proposed standard is its forward-looking perspective. The authorities have recognized that emission reduction is a journey, not an instantaneous achievement. Therefore, the standard mandates industries exceeding the established emission thresholds to develop and implement a schedule outlining specific actions to reduce their VOC emissions. This provision aligns well with the global trend towards sustainable industrial practices and acknowledges that emission reduction is often a phased process that requires careful planning and execution.

Crucially, the Mexican government has also recognized the importance of public participation in shaping environmental policies. The draft standard is open for public consultation, inviting input and feedback from stakeholders and citizens alike. This inclusive approach ensures that the regulations are well-rounded, practical, and sensitive to the needs and concerns of various sectors of society.

For those interested in contributing, the window for submitting comments is open until September 15th.

New Zealand's Environmental Protection Authority (EPA) has taken a significant step in enhancing the regulation of hazardous substances by issuing the Hazardous Substances (International Regulators) Notice 2023. This notice, published in the New Zealand Gazette, is in accordance with section 76E of the Hazardous Substances and New Organisms Act 1996 (HSNO Act).


The primary objective of this notice is to officially recognize and designate certain overseas entities as international regulators for the purposes of sections 28A and 63D of the HSNO Act. This move is poised to strengthen New Zealand's commitment to ensuring the safety and control of hazardous substances within its borders.


The objective of the Hazardous Substances (International Regulators) Notice 2023 is to introduce a new notice under section 76E of the HSNO Act. The notice encompasses several countries whose regulatory bodies have been thoroughly evaluated by the EPA in accordance with the criteria outlined in section 76E(3) of the Act and will come into force on October 1, 2023. The following overseas bodies have been officially recognized as international regulators under section 76E(1) of the Act, effective from the date of the notice:



Australian Pesticides and Veterinary Medicines Authority

Australian Industrial Chemicals Introduction Scheme



Pest Management Regulatory Agency


European Union

European Food Safety Authority

European Chemicals Agency

European Commission


United Kingdom

Chemicals Regulation Division of the Health and Safety Executive


United States

United States Environmental Protection Agency


The recognition of these international regulators highlights New Zealand's commitment to aligning its hazardous substances management practices with established and respected international standards. This measure is expected to enhance cooperation and information sharing among these regulatory bodies, contributing to safer and more effectively managed hazardous substances in New Zealand.


The EPA has expressed its dedication to regularly reviewing and updating the list of recognized international regulators to ensure the highest level of safety and compliance within the country. Stakeholders and interested parties are encouraged to familiarize themselves with the changes introduced by this notice in preparation for its implementation on October 1, 2023.

In New Zealand the Environmental Protection Authority (EPA) is actively seeking feedback from stakeholders on a proposed infringement offence scheme for hazardous substances under the Hazardous Substances and New Organisms Act 1996 (HSNO Act). The closing date for submissions is August 28, 2023. The valuable insights gathered will contribute to refining the scheme before final policy proposals are presented to Cabinet for consideration. 

The Ministry for the Environment (MfE) and the Environmental Protection Authority (EPA) have collaborated on a significant initiative to enhance protection for the environment and the well-being of people and communities in relation to hazardous substances. Their joint effort has led to the proposal of an infringement offence scheme under the HSNO Act. 

The primary goal of this scheme is to bridge the existing gap in enforcement tools for hazardous substance offences under the HSNO Act. Currently, there is a lack of an intermediate enforcement measure between compliance orders and prosecution, which restricts the authorities' ability to address hazardous substance violations at lower levels adequately. 

The proposed infringement offence scheme outlines a list of offences and their associated fees. These offences are characterized as being straightforward  factual matters that can easily be identifed by enforcement officers. They also involve minor or less serious matters that do not warrant prosecution and are suitable for on-the-spot fines. Importantly, the scheme ensures that no criminal convictions arise from these infringement offences. 

Upon approval by the Cabinet, the new hazardous substances infringement regulations will be formally announced in the New Zealand Gazette and on the EPA's official website. The proposed fines for infringement offences range from NZ$ 200 to NZ$ 3,000. 

This innovative step by the MfE and EPA promises to bolster environmental protection and safeguard the health and safety of the people and communities across New Zealand. By establishing a more effective enforcement framework, they are taking a proactive approach to address hazardous substance issues in a manner that befits the gravity of the offences. 

On 14 July 2023 the Bangladesh Food Safety Authority (Ministry of Food) notified two draft food safety regulations to the World Trade Organization (WTO): the Draft Food Safety (Chemical Contaminants and Toxins) Regulation 2023 and the Draft Food Safety (Pesticides Residues and Other Chemical Residues) Regulations, 2023. Both drafts are open for comments until 12 September 2023.

Draft Food Safety (Chemical Contaminants and Toxins) Regulation 2023:

The draft contains measures aimed at decontaminating contaminated feed or food and preventing it from being marketed. Consumption of contaminated food can pose a threat to human health and animals. Furthermore, in some cases, it can also cause negative effects.

The Regulation specifies the maximum level of contaminants and toxins in food and feed (e.g., heavy metals, radionuclides, nitrates, polychlorinated biphenyls (PCBs), dioxin, mycotoxins and other toxins).

The draft includes seven schedules containing the name of the contaminants and their maximum levels in feed and food articles. The substances are considered harmful if present in excess than the maximum level. The following are the contaminants mentioned in the schedules:




Aflatoxin's total



Aflatoxin M1



Deoxynivalenol (DON)


Hydrocyanic acids




Ochratoxin A

Methyl mercury

Vinyl chloride monomer













 More details on the maximum levels can be found here.

Draft Food Safety (Pesticides Residues and Other Chemical Residues) Regulations, 2023:

The maximum level of pesticide residue permitted in food or feed is introduced in the draft. The controlling measures of pesticides residues in food products that are hazardous to health are listed in Schedule 1 to Schedule 3.

This regulation describes the parts of raw agricultural commodities to which the maximum residue limits in Schedule 1 and Schedule 2 apply. Unless other wise specified the agricultural raw materials to which maximum residue limit is applied and which is processed as the analytical sample for determination of pesticides residue is as described in the Schedule3.

The Pesticides Residues and Other Chemical Residues Schedule 1 to Schedule 3 can be found here :


On 27 July 2023, the United Nations Economic Commission for Europe (UNECE) published the 10th revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS10). The publication comes after the Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labelling of Chemicals approved a series of amendments to the ninth revised edition of the GHS at its eleventh session on 9 December 2022. These amendments cover various subjects, including:

  • Refinement of the classification procedure for desensitized explosives (Chapter 2.17)

  • Implementation of non-animal testing methods for the classification of health hazards, with a particular focus on skin corrosion/irritation (Chapter 3.2), serious eye damage/irritation (Chapter 3.3), and respiratory or skin sensitization (Chapter 3.4).

  • Rationalisation of precautionary statements to enhance user understanding without compromising their usefulness for labeling practitioners.

  • Review of annexes 9 and 10 to ensure alignment of the classification strategy, guidance and tools on metals and metal compounds with the provisions for long-term aquatic classification toxicity in chapter 4.1.

The electronic version of GHS10 will be available for free here for consultation purposes in the six official UN languages (Arabic, Chinese, English, French, Russian, and Spanish). As of now, only the English and French editions have been published. The other language versions will be added as soon as they become available.