GPC Newsletter Jul-2023

The Environmental Protection Agency (EPA) of the United States has recently received several pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities. This announcement was made in a WTO notification on July 14, 2023, through the document titled "Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities. Notice of filing of petitions and request for comment."

The objective and rationale behind these proposed regulations are primarily focused on ensuring food safety. The regulations aim to address residues of pesticide chemicals in commodities to safeguard the health of consumers. Additionally, there is no indication of deviations from relevant international standards, as confirmed by the absence of any identified international standard.

The commodities covered by these petitions are not specified in the information provided. However, it is essential to note that these regulations could impact all trading partners, signifying the potential global implications.

As of now, the proposed dates of adoption and publication have not been determined. The exact date of entry into force is also yet to be finalized. The public has an opportunity to provide comments and feedback on these proposed regulations until August 4, 2023. Comments can be addressed to the EPA's Biopesticides and Pollution Prevention Division or the Registration Division, as mentioned in the official document. Interested parties can refer to the full text of the document here for further details.

It is important for stakeholders and the public to keep an eye on developments in this matter, as the proposed regulations may have significant implications for food safety and trade.

The European Commission adopted a Proposal for a Regulation on the management of end-of-life vehicles and standards for circularity in vehicle design on July 13, 2023. The adopted act is open for feedback until September 26, 2023. 

 In terms of reusability, recyclability, and recoverability of materials used in vehicles, as well as information and labelling requirements for parts, components, and materials used in vehicles, this proposed regulation establishes circularity requirements. It also specifies rules for extended producer responsibility, the collecting and disposal of vehicles at the end of their useful lives, and the export of old cars from the Union to foreign nations. 

In Europe, more than six million vehicles approach the end of their useful lives each year. Poor handling of cars near the end of their useful lives causes pollution and value loss. The evaluation of the existing EU laws governing the area, Directive 2000/53/EC on end-of-life vehicles (the "ELV Directive," adopted in 2000), and Directive 2005/64/EC on the type-approval of motor vehicles with regard to their reusability, recyclability, and recoverability ("3R type-approval Directive," adopted in 2005), has revealed that significant improvements were required to boost the transition of the automotive sector to a circular economy and thereby reducing the amount of waste that is produced. 

The transition to zero-emission vehicles depends on strengthening the EU's resilience against supply chain disruptions and lowering its reliance on imports of vital raw materials. To help the industry adapt, the Commission has updated the law and suggests a single regulation that emphasises a number of crucial components to raise design, collection, and recycling quality while simplifying reporting requirements: 

This action plan is anticipated to provide significant environmental advantages, such as: 

• A decrease in yearly CO2 emissions of 12.3 million tonnes by 2035 

• Improved material valorisation of 5.4 million tonnes 

• Higher recovery of essential raw materials 

• Long-term energy savings at the production stage and a decrease in reliance on imported raw materials. 

The European Parliament and the Council will now review the Commission's proposal for a rule on the management of end-of-life vehicles and on circularity standards for vehicle design. 

On 26 July 2023, the European Commission published Regulation (EU) 2023/1545 in the Official Journal of the European Union, amending Regulation (EC) No 1223/2009 (the Cosmetics Regulation) concerning the labelling of fragrance allergens in cosmetic products. The Regulation will come into force on 15 August 2023.

So far 26 fragrance allergens listed in Annex III of the Cosmetics Regulation must be mentioned in the list of ingredients (individual labelling). However, in an opinion published by the Scientific Committee on Consumer Safety (SCCS) in 2012 identified a further 56 additional fragrance ingredients in cosmetic products that clearly caused allergies in humans and that did not have any requirement of individual labelling.

Regulation 2023/1545 introduces new obligations to individually label the 56 additional fragrance allergens listed by the SCCS. These allergens must be labelled individually if their concentration surpasses 0.001% in leave-on products and 0.01% in rinse-off products. The introduction of these new obligations is accomplished by generating new entries in Annex III to Regulation (EC) No 1223/2009. Under the new regulation, there is a strong emphasis on maintaining consistency and clarity. To achieve this, certain existing entries for fragrance allergens in Annex III to Regulation (EC) No 1223/2009 are being updated. The aim is to align the common names of substances with the most recent version of the Common Ingredients Glossary, as referenced in Article 33 of the Regulation. Moreover, similar substances will be grouped together, streamlining the labeling process and minimizing any potential confusion.

The list of affected fragrance allergens can be found here. There will be a transition period of 3 years for adapting product formulations and containers so that only cosmetic products complying with the new requirements are placed on the market. A 5-year transition period is given to withdraw cosmetic products from the market which do not comply with the new requirements and were placed on the market before the new labelling provisions become applicable.

On 14 July 2023, the European Commission adopted a proposal to revise the Mercury Regulation and thereby ban all remaining intentional uses of the metal.  The Commission proposal was adopted in parallel to a delegated act (Prohibition against the manufacture, import and export of eight additional mercury containing products), aligning the revision with decisions taken by the 4th Conference of Parties (COP4) of the Minamata Convention.

Mercury is a highly toxic chemical which poses significant hazards to both human health and the environment. Upon its release into the ecosystem, enters the food chain, primarily accumulating in fish. Exposure to elevated levels of mercury can lead to detrimental effects on the brain, lungs, kidneys, and the immune system.

The revised Mercury Regulations targets uses of mercury in a number of products in the EU some of which are listed below. These are consistent with the commitments in EU’s Zero Pollution Ambition.

• A total phase-out of the use of dental amalgam will be introduced from 1 January 2025 whereby human exposure and the environmental burden will be reduced.

• Manufacture and export of dental amalgam from the EU will be prohibited from 1 January 2025.

• Manufacture and export of six mercury containing lamps will be prohibited from 1 January 2026 and 1 January 2028 depending on the type of lamps.

The delegated act adopted under the Mercury Regulation incorporates decisions made at COP4 into EU law. It achieves this by introducing a prohibition on the manufacture, import, and export of the eight products containing mercury, including mercury-containing lamps, tire balancers/wheel weights, photographic film and paper, and mercury vacuum pumps.

The Minamata Convention entered into force on 16 August 2017, is the main international legal framework seeking to protect human health and the environment from anthropogenic emissions and releases of mercury to air, water and land. Like the Mercury Regulation, it addresses the whole life cycle of mercury, from primary mercury mining to mercury waste disposal. The convention has been ratified by the EU and 143 countries, including all the EU member states.

The revised Mercury Regulation will now be subject to the approval of the European Parliament and the Council as part of the ordinary legislative procedure. The delegated act is transmitted to the European Parliament and the Council for their scrutiny.

On 14 July 2023, the European Commission adopted an amendment (Commission Regulation (EU) 2023/1464) to the REACH Regulation which introduces maximum emission limit for formaldehyde in a variety of consumer products.

Formaldehyde is mostly used in the production of resins, thermoplastics, and other chemicals. These chemicals are then incorporated in a range of consumer products and applications, such as in the manufacturing of wood-based furniture and flooring, which are the main sources of exposure to formaldehyde emissions in indoor air for consumers. It is also used in textile and leather products, parts for vehicles and aeroplanes, as well as foams, plastic, and synthetic vitreous fibres.

Formaldehyde is classified as carcinogenic (category 1B), mutagenic (category 2) in the European Chemicals Agency’s classification and labelling inventory. Furthermore, it has acute toxicity (category 3), skin corrosive (category 1B) and skin sensitising (category 1) properties.

The following table summarizes the emission limits of formaldehyde into air established by the new rule for various types of products. The limits will ensure a high level of protection for human health and at the same time limit the socio-economic burden as well as the need for technological changes for a wide range of industries and sectors. There will be a 36-month transition period which will give producers of articles where formaldehyde is used sufficient time to implement the restriction requirements, develop relevant analytical methods to test formaldehyde emissions, and start utilizing formaldehyde-free or low emitting formaldehyde products. For vehicles the transition period will be 48 months.

When it comes to wood-based articles and furniture the following articles are exempted:

1. Articles in which formaldehyde or formaldehyde releasing substances are exclusively naturally present in the materials from which the articles are manufactured.

2. Articles exclusively for outdoor use under foreseeable conditions.

3. Articles in constructions, that are exclusively used outside the building shell and vapor barrier and that do not emit formaldehyde into indoor air.

4. Articles exclusively for industrial or professional use unless formaldehyde released from these leads to exposure of the general public under foreseeable conditions of use

5. Articles falling under the scope of entry 72 to Annex XVII of the REACH Regulation

6. Articles that are biocidal products within the scope of Regulation (EU) 528/201.)

7. Medical devices (Regulation (EU) 2017/745)

8. Personal protective equipment within the scope of Regulation (EU) 2016/425.

9. Food contact materials and articles within the scope of Regulation (EU) 1935/2004.

10. Second-hand articles

When it comes to road vehicles the following exemptions apply:

1. Road vehicles exclusively for industrial and professional use, unless the concentration of formaldehyde in the interior of those vehicles leads to exposure of the general public under foreseeable conditions of use.

2. Second-hand vehicles

The regulation emphasizes that toys for children of all ages fall within the scope of restrictions. The limit value for formaldehyde emissions into indoor air therefore applies to toys for children of all ages.

The European Chemicals Agency (ECHA), with the support of industry and experts, will develop guidance to facilitate the harmonised implementation of the test conditions for the measurement of formaldehyde emissions.

The full text of Commission Regulation 2023/1464 can be found here.

On 6 June 2023, the Scientific Committee on Consumer Safety (SCCS) of the European Union adopted the second revision of its Guidance on the Safety Assessment of Nanomaterials in Cosmetics. The guidance on nanomaterials should be used in conjunction with the general guidance for the submission of safety dossiers of cosmetic ingredients “The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 12th revision, SCCS/1647/22” or any future revision.

In the EU, the use of nanomaterials in cosmetics is specifically covered under the Cosmetic Regulation (EC) No 1223/2009, which provides a definition of a nanomaterial (NM) and requires premarket notification, safety evaluation, and labeling of cosmetics containing NM ingredients. If the European Commission has concerns regarding the safety of an NM, the Commission shall refer it to the SCCS for a scientific opinion.

This Guidance is an up-to-date revision of the existing Guidance (SCCS, 2019) and aims to provide an overview of the key issues and data requirements relating to the safety assessment of NMs in cosmetics. The revision contains a number of changes. New sections have been introduced covering aspects such as solubility and dissolution rate, solubility in non-aqueous media, evidence for the absence of nanoparticles, dispersion, aspect ratio, uptake into blood cells, reproductive toxicity, and endocrine disruption. The European Commission recommendation for a definition of nanomaterials published in 2022 has been incorporated. Key aspects triggering safety concerns over a nanomaterial based on the SCCS’s scientific advice on the safety of nanomaterials in cosmetic (SCCS/1618/2020) have been introduced, providing a clearer understanding of potential risks associated with nanomaterials. Additionally, Annex 1 and other sections of the Guidance have been updated based on recent literature, the section on read-across and grouping has been revised and a text explaining when historical/existing data can be used has been included.

The full text of the revised Guidance can be found here.

On 10 July 2023, the European Commission adopted a new regulation on sustainable management of batteries and waste batteries. The regulation will apply to all batteries including all waste portable batteries, electric vehicle batteries, industrial batteries, starting, lightning, and ignition (SLI) batteries (used mostly for vehicles and machinery), and batteries for light means of transport (e.g., electric bikes, e-mopeds, e-scooters). 

The new regulation is designed to promote fair competition and enhance the efficiency of the internal market for batteries. 

 Performance, durability, and safety standards, strict restrictions for dangerous chemicals like mercury, cadmium, and lead, as well as required disclosure of the carbon footprint of batteries all contribute to achieving this. The regulation adds labelling and information requirements, including those for an electronic "battery passport" and a QR code, as well as information on the battery's components and recycled content. Labelling rules will be in effect by 2026 and the QR code by 2027, providing member states and market participants time to be ready. 

The regulation seeks to minimize any negative effects on the environment and society during the battery's entire life. To do this, the regulation sets strict due diligence requirements for operators who must confirm the origin of the raw materials used in the batteries they sell. The regulation allows SMEs to be excluded from the requirements for due diligence. 

The regulation on batteries targets every phase of the life cycle of batteries, from design to waste treatment, with the goal of establishing a circular economy for the battery industry. This endeavour is quite significant, especially considering the rapid advancement of electric mobility. By 2030, the need for batteries is anticipated to have multiplied more than ten-fold. The new rule will complete the law and replace the present batteries directive from 2006, notably with respect to waste management. 

By regulating batteries throughout their life cycle, the new regulations seek to advance a circular economy. Consequently, the rule establishes end-of-life criteria, such as collection responsibilities, goals for material recovery, and expanded producer accountability.  

The regulation sets the below targets: 

The adoption process was concluded by the Council’s vote. The Council and European Parliament will now ratify the regulation. Then, it will likely go into effect on 30 July 2023 after being published in the Official Journal of the EU. 

The full text of the regulation can be found here. 

On 26 June 2023, a proposed exemption for the use of cadmium and lead in polyvinyl chloride (PVC) under Annex IV of the EU Directive on the restriction of hazardous substances (RoHS) in electrical and electronic equipment was put out for discussion by the European Commission. The draft delegated directive's consultation period began on 27 June and will expire on 25 July. 

The proposed  

exemption would be for the use of cadmium and lead in plastic profiles in electrical and electronic windows and doors containing recovered PVC. In polyvinyl chloride (PVC), lead and cadmium are employed as thermal stabilisers. Such uses were covered by the prior exception 41 in Annex IV of the RoHS Directive. 

Cadmium is restricted by entry 23 of Annex XVII to the REACH Regulation. The restriction does not apply to articles containing recovered PVC if their concentration of cadmium does not exceed 0,1% by weight of the plastic material in articles, including doors and windows. Lead is restricted by entry 63 of Annex XVII to the REACH Regulation and shall not be placed on the market or used in articles produced from polymers or copolymers of PVC, if the concentration of lead is equal to or greater than 0,1 % by weight of the PVC material. 

The technical and scientific evaluation of the proposed exemption concluded that:  

• Cadmium and lead are used in PVC frame material for windows and door sets for the purpose of polymer stabilisation of the PVC profiles. 

• Most of the applications for window and door sets are not electrical. Only a small amount compared to all windows and doors requires a time-limited exemption as they are EEE according to Article 3(1) of the RoHS Directive. 

• While lead- and cadmium-free technologies used in virgin PVC are available on the market, use of recovered PVC requires lower amounts of energy and natural resources (such as water, petroleum and natural salt) than would be otherwise needed for use of virgin PVC. The use of recovered PVC is thus associated with socio- economic benefits in particular with regard to decarbonisation, circular economy and raw material availability. 

The proposed exemption therefore complies with Article 5 (1) (a) of the RoHS Directive: the total negative environmental impact, health impact, and consumer safety impact that may arise through substitution may exceed the overall environmental impact, health impact, and consumer safety benefits it generates. Therefore, the recycling and use of PVC containing lead and cadmium is related to socio-economic benefits and helps to reduce carbon emissions and promote a circular economy. 

The exemption is requested for 5 years which is the maximum validity period according to Article 5(2) of the RoHS Directive. 

On 22 June 2023, the European Chemistry Agency (ECHA) announced that its Committee for Socio-Economic Analysis (SEAC) supports the gradual ban on per- and polyfluoroalkyl substances (PFASs) in firefighting foams proposed by ECHA in February 2022. The restriction could reduce the emission of PFAS into the environment by approximately 13 200 tonnes over a period of 30 years.

The REACH Annex XV restriction dossier for an EU-wide restriction on all PFASs in firefighting foams was proposed by ECHA on 27 February 2022. The aim of the restriction is to prevent further contamination of groundwater and soil as well as health risks for humans and the environment. All PFASs, or their breakdown products, are very persistent and some are known to harm human health or the environment. The combination of persistence and the potential to cause harm means that it is important to minimise further releases of these substances to reduce the likelihood of, potentially irreversible, harm in the future.

The restriction dossier sets a concentration threshold of 1 ppm for remaining PFAS-contamination in firefighting foam systems. Furthermore, the dossier gives sector-specific transition periods that allow time to replace PFAS-containing foams without compromising fire safety.

On 23 March 2023 ECHA’s Committee for Risk Assessment (RAC) published their support of the restriction dossier. The RAC concluded that there is an EU-wide risk for humans and the environment from the use of PFASs in firefighting foams since 470 tonnes of PFAS is released into the environment each year. The RAC stated that the proposed restriction would effectively reduce emissions and the associated risks posed by these persistent substances.

In its opinion published on 22 June the SEAC considers that the proposed restriction on the placing on the market, use and formulation of PFAS in firefighting foams is the most appropriate EU-wide measure to address the identified risks. These conclusions follow the opinion of the RAC mentioned above. However, the SEAC suggests:

• that a review of available fluorine-free alternatives for sites that produce, treat or store dangerous substances (covered by the Seveso Directive) and those neighbouring them is carried out before the end of the 10-year transition period.

• that a review is needed for uses at offshore installations in the oil and gas industry, where SEAC is recommending lengthening the transition period from five to 10 years. The committee considers the reviews important to maintain safety where fires may have high impacts on the environment and human health.

• that the transition periods for uses in civilian shipping are lengthened from three to five years and the transition period for placing certain types of portable fire extinguishers on the market from lengthened from 6 to 18 months. This is to ensure that technically suitable fluorine-free alternatives are available when the transition periods end.

The next step for the PFAS restriction dossier requires that ECHA combines the opinions of RAC and SEAC into one for publication and submits the opinion and the restriction proposal to the European Commission. The Commission will then decide whether a restriction is necessary. If that is the case the Commission will make a proposal to amend the list of restrictions of the REACH regulation (Annex XVII). The proposal will be voted on by the EU Member States in the REACH Committee and scrutinised by the European Parliament and Council before adoption into law.

On 26 June 2023, the European Chemicals Agency (ECHA) started a targeted public consultation on the harmonised classification and labelling of metyltetraprole (ISO); 1-[2-({[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy}methyl)-3-methylphenyl]-4-methyl-1,4-dihydro-5H-tetrazol-5-one. The deadline for commenting the consultation is 10 July 2023.

The reason for this extra consultation for metyltetraprole (ISO) is that ECHA received eight documents containing additional information on carcinogenicity after the first consultation ended on 10 March 2023. Comments can be submitted here. EHCA’s Committee for Risk Assessment will take the new info into account when developing its opinion.

On 8 June 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published preliminary opinions on the use of methylparaben and butylparaben in cosmetics. The European Commission has opened public consultation on the 2 preliminary opinions and the deadline for comments is 21 August 2023.

Methylparaben and butylparaben have been assessed to rule out potential endocrine-disrupting properties and to ensure their safe use in cosmetics. The EU’s Cosmetics Regulation (Regulation (EC) No 1223/2009) does not have explicit provisions for the management of endocrine disruptors (EDs) therefore the European Commission requested the SCCS to conduct safety assessments on the two substances.

The conclusion of the SCCS in the two preliminary opinions was that methylparaben and butylparaben are safe for use as preservatives in cosmetics when used as summarized in the following table.

According to the SCCS, methylparaben and its salts are widely used in cosmetics, food products, and pharmaceutical formulations. In cosmetics it is the one used most frequently. It is either used alone ore in combination with other parabens or other antimicrobial agents. Butylparaben has been widely used as a preservative in cosmetics and pharmaceutical preparations for 70 years.

The preliminary opinion for methylparaben can be found here and the one for butylparaben can be found here.

On 6 July 2023 the UK Government published an amendment, the Cosmetic Products (Restriction of Chemical Substances) Regulations 2023, to the retained EU legislation, Regulation (EC) No 1223/2009 (the Cosmetics Regulation). The amendment is applicable in England, Scotland, and Wales and regards permitted levels of Methyl-N-methylanthranilate (M-N-MA), Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (HAA299), and HAA299 (nano).

The following restrictions regarding the fragrance ingredient M-N-MA are added to Annex 3 which is a list of substances which cosmetic products must not contain except subject to the restrictions laid down. The regulation comes into force on 6 July 2024 however a cosmetic product that is placed on the market prior to 6 July 2024 can continue to be made available on the market until 6 July 2026.

• For leave-on products the maximum threshold for M-N-MA is 0.1 % and for rinse-off products it is 0.2 %

• M-N-MA is not to be used in leave-on sunscreen products and products marketed for exposure to natural or artificial UV light

• M-N-MA should not be used with nitrosating agents

• Maximum nitrosamine content is 50 µg/kg

• Keep in nitrite-free containers

HAA299 and HAA299 (nano) are added to the list of UV filters allowed in cosmetic products (Annex 6). This regulation comes into force on 28 July 2023.

• The maximum threshold for both substances is 10 %

• In case of combined use of HAA299 and HAA299 (nano), the sum shall not exceed 10 %.

• For HAA299 (nano) only nanomaterials with a purity ≥ 97 % and a median particle size D50 (50 % of the number below this diameter): ≥ 50 nm of number size distribution are allowed.

• HAA299 (nano) is not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.  

On 29 June 2023, the Retained EU Law (Revocation and Reform) Act 2023 received royal assent and is now act of parliament (law). Schedule 1 of the Act lists approximately 600 retained EU laws that will be revoked on 31 December 2023. More details on the amendment can be found here.

The Act revokes Annex VIII of the classification, labelling and packaging (CLP) regulation (poison centres) in Great Britain which had been carried over into GB law in error following the UK’s departure from the EU (Brexit). It had been the plan of the UK government to implement a voluntary scheme for poison centre notifications after Brexit instead of the mandatory provisions under Annex VIII of the EU CLP. Annex VIII requires importers and downstream users in the EU to submit information on hazardous mixtures in form of a Poison Centre Notification (PCN) which allows poison centres to advice citizens or medical personnel in the event of a poisoning.

It is expected that the revocation will have the following implications:

• UK companies will no longer be obligated to provide the full Poison Centre data as specified in Annex VIII.

• The administrative burden for companies will be reduced since compliance with the detailed requirements of Annex VIII can be complex and time-consuming for companies.

• Clarification for the chemical industry in the UK that they will not be required to comply with the specific poison centre data submission requirements outlined in Annex VIII eliminating any potential confusion that may have arisen from its accidental inclusion.

It is expected that a voluntary scheme for poison centre notifications will be implemented where importers and downstream users are encouraged to voluntarily submit information to the National Poison Information Service (NPIS) by using a Safety Data Sheet (SDS).

The full text of the Retained EU Law (Revocation and Reform) Act 2023 can be found here.

Türkiye introduced legislation for chemicals which is similar to REACH, called KKDIK. Since the regulation was accepted by the Ministry of Environment, Urbanisation and Climate Change (MoEUCC) on 23rd of December, 2017, the aim was to protect the health of society and the environment.

The number of lead registrant dossiers has increased from 2,821 to 2,967, which means 146 more substance has new lead registrant currently. Even though there have been more than 42,000 reference substances on the system called KKS, the majority of these are generated by exemptions and repeated substances. Hence, it is hard to estimate the exact number now.

As long as the deadline for registering substances for the KKDIK is 31st of December 2023, to continuity of the business, firms that manufacture and/or import to Türkiye, must register their substances. Furthermore, if you have the intention to be a leader register for the substance, GPC Türkiye suggests you hurry up before that time. Additionally, if you are a manufacturer out of Türkiye and exporting chemicals to Türkiye, we as a company also provide you OR service. To learn more about your responsibilities and support you are more than welcome to reach us!

The Central Government of India has extended the enforcement date for 10 substances under the Quality Control Order (QCO). The amended enforcement dates were published by the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals in the Indian Gazette on 21 July 2023. The Quality Control Order is the regulation that requires concerned substances to carry the certification mark of the Bureau of Indian Standards (BIS). The 10 substances and their previous and new enforcement dates are listed in the table below.

The full text of the Gazette notification for the 10 substances can be found here.

At the end of June 2023, the Bureau of Indian Standards (BIS) published a draft amended standard for surface cleansers that contain quaternary ammonium compounds (QUACs). BIS is accepting comments on the draft until August 31. This is the standard's first change since 1996. In this first revision, the requirements for total non-volatile matter, pH and QAC content have been modified. Furthermore, the packing and marking clauses have been updated. 

QUATs are antibacterial agents that can be added to conventional liquid cleaners based on soap and detergents to deal with bacteria. A product of this type helps to create hygienic environment through cleaning and reducing the effect of bioburden (i.e. the number of bacteria living on a surface that has not been sterilized). The quaternary ammonium compounds (QAC) may be cetylpyridinium chloride, cetalkonium chloride, benzalkonium chloride, or any quaternary ammonium compound, suitable for the purpose. 

• The following are the suggested specifications for cleaners containing QUACs:   

The draft standard indicates that the cleaners containing QUACs should be contained in glass bottles or suitable plastic containers, provided with a pilfer proof cap made of either metal or plastic and be marked with the following: 

a) Indication of the source of manufacture 

b) Net content of the material 

c) Name of the material 

d) Month and year of manufacture, and Batch No. or Code No. 

e) Direction for use 

f) Cautionary label 'DO NOT MIX WITH HOUSEHOLD SOAP AND DETERGENTS'. 

On June 7, 2023, the Indian Central Board of Indirect Taxes & Customs (CBIC) issued Circular No. 15/2023 which makes it mandatory to provide additional parameters for imported goods such as scientific names, IUPAC names, brand name, CAS number, etc. along with the complete details of imported products. The requirements were to come into force on July 1, 2023. However, on June 30, 2023, the CBIC introduced an amendment to the circular deferring the date for the mandatory additional requirements for import/export of certain products from July 1, 2023, to October 1, 2023.  

The circular was further discussed with the Department of Chemicals and Petrochemicals, the Ministry of AYUSH, and the Directorate General of Foreign Trade (DGFT). It was concluded that providing the complete details of the products on import/export declarations can clear the way for effectiveness in assessment, avoidance of queries, and speed up clearance processes. 

Following mandatory requirements are added for import/export declarations: 

• The declaration of IUPAC name and CAS number of the constituent chemicals for imports. 

• The declaration of the name of the medicinal plant, for exports of parts of plants. 

• The declaration of the name of the formulation, for exports of formulations of different streams of medicine. 

• The declaration of the surface material that comes into contact with the chemical, for exports of various products. 

On June 21, 2023, the Bureau of Indian Standards (BIS) published a revised draft standard for soap noodles. BIS will take comments on the draft till August 31, 2023. The draft is an updated version of IS10513, which was first issued in 1983, has been approved by BIS for use with soap noodles. The standard covers requirement for “soap noodles” used as an intermediate product for subsequent conversion into marketable soaps. The phrase "Sodium oleostearate noodles" has been changed to "Soap noodles" in this revision, since soap noodles presently are made from different blends of oils and benefit ingredients.

The 1983 version of the standard did not differentiate between soaps used for personal care, laundry, or other purposes, like those used in the industry. In this revision 3 categories of soaps are included: Type 1 personal care soaps (pure soap noodles), Type 2 laundry soaps, and Type 3 is “other soap noodles” which covers different combinations of soap and other beneficial ingredients as agreed between the manufacturer and supplier.  According to Cosmetic Rules 2020, all ingredients used in cosmetic products, such as personal care soap, must adhere to Indian Standards (IS) 4707 (Part 1 and Part 2), the Drugs and Cosmetics Act 1940 & Rules 1945.

The revision gives the following restrictions for heavy metals and other chemicals for the three product categories:

The draft furthermore addresses ingredients like fatty acids, oils, and electrolytes that are used in the manufacturing processes.

In addition, the manufacturer's name, the date of manufacture, the name and type of substance, the lot and batch number, and other requirements have been standardized for packaging and labels. 

Following consultation with the Bureau of Indian Standards (BIS), the government decided to defer implementation of of two essential quality control orders (QCO), according to an announcement by the Department of Chemicals and Petrochemicals (DCPC) that was published in the Gazette of India on June 21, 2023 (full notice can be found here. 

The execution of the two QCOs has been further delayed till December 22, 2023, by India's Department of Chemicals and Petrochemicals (DCPC). 

Originally set to go into effect on December 21, 2022, the QCOs were later postponed until June 22, 2023. They include: 

• N-Butyl Acrylate is used to make solvents, varnishes, adhesives, paints, binders, emulsifiers, polymers and resins for finishing leather and textiles. 

• Toluene is a chemical that is used in the production of paint, paint thinner, lacquers, adhesives, rubber, and methods for tanning leather. 

The two chemicals continue to be subject to the current norms and regulations until December 22, 2023. 

The National Center for Food Safety Risk Assessment of China (CFSA) published a notification to solicit public opinions on four food related products, including expanding the use scope of two food contact materials (FCM), one new origin of FCM and one new varieties of resins for FCM. 

• Expanding the use of two FCMs

CFSA has expand the usage scope of resin 2-propenoic acid, 2-methyl-,1,1-(1,4-butanediyl) ester polymer, with butyl 2-methyl-2-propenoate, butyl 2-propenoate and methyl 2-methyl-2-propenoate in coatings and coating layers.  

The maximum use level would be 46% based on the coating formula and a specified migration limit (SML) of 6mg/kg for methacrylate and of 0.05 mg/kg for 1,4-butanediol dimethacrylate. Coatings containing this resin would be banned for use in packaging for foods containing fat or for infants and young children. 

• One new origin of FCM

Coffee grounds has been permitted to use in plastics: polylactic acid (PLA), polybutylene succinate (PBS). The maximum usage is PLA: 20; PBS: 10. The collection, production, processing, storage and transportation of coffee grounds should comply with the relevant provisions of the "National Food Safety Standard General Hygienic Specifications for Food Production" (GB 14881-2013). It shall not be used in the production of special food contact materials and products for infants, and the operating temperature shall not be higher than 100°C. The above restricted use requirements shall be marked in accordance with the provisions of GB 4806.1

• One new varieties of resins for FCM

2-propenoic acid, 2-methyl-,1,1-(1,4-butanediyl) ester, polymer with butyl 2-methyl-2-propenoate, butyl 2-propenoate and methyl 2-methyl-2-propenoate have been permited to use in paint and coating. The maximum usage is 46%, and SML is 6 mg/kg (methacrylic acid) 0.05 mg/kg (1,4-butanediol dimethacrylate). It shall not be used in the production of special food contact materials and products for infants and shall not be used in contact with fat-containing foods. The above restricted use requirements shall be marked in accordance with the provisions of GB 4806.1.

For more information regarding China FCM compliance or China REACH and cosmetic activities, please contact GPC via compliance@gcpregulatory.cn.

The National Health Commission of China (NHC) published notifications for 2023 food safety related national standards legislation plan and 2024 food safety related national standards legislation suggestion. 

The 2023 national standards legislation plan contains the following 9 sections of different food safety areas. 

• 12 food addictive national standards 

The standards regarding Sodium L-malate, Vanillol and Sanzan Gum will be made for the first time. The standards regarding Tomato Red, Capsicum Red, Pectin, Vitamin B2, Lauric Acid, General Rules for Food Additive Labeling, L-Alanine, Erythritol, L-Cysteine Hydrochloride will be modified based on the current versions.

• 1 food related products standard

The addictive for food contact materials standards (GB 9685-2016) will be modified.

• 3 pollutants standards 

The following 3 pollutants standards will be modified: Limits of Heavy Metals in Dried Meat Products, Limits of Heavy Metals in Dried Aquatic Products, Limits of Contaminants and Mycotoxins in Liquid Special Medical Foods. 

• 11 physical testing methods 

The physical testing methods of Determination of trans fatty acids in food for infants and young children and dairy products (GB 5413.36-2010), Determination of Amino Acids in Food (GB 5009.124-2016), Determination of Indicative PCB Content in Food (GB 5009.190-2014), Determination of perfluoroalkyl compounds in food (GB 5009.253-2016) will be modified based on current standards. The physical testing standards of Food contact materials and articles Determination of 2-methyl-1,3-butadiene and determination of migration, Food contact materials and articles - Determination of migration of citrate and sebacate compounds, Food contact materials and products - Determination of migration of bisphenol A-diglycidyl ether, bisphenol F-diglycidyl ether and their hydroxyl and chlorinated derivatives and etc. 7 standards will be made. 

• 5 micro-biology testing methods 

Food microbiological examination - Examination of diarrhea-causing Escherichia coli (GB 4789.6-2016), Bacteria inspection for food, Bifidobacteria inspection and etc 5 micro-biology testing methods will be made or modified. 

• 1 toxicological testing methods

The toxicological testing methods of Pig-a Gene Mutation Test in Peripheral Blood of Rats in Vivo will be made in 2023. 

• Food product standards

The standards of Vegetable oil (GB 2716-2018) will be modified. 

• 2 special dietary food standards

The standards of Gastrointestinal malabsorption, pancreatitis full nutritional formula food and Foods for special diets for people with gluten intolerance will be made. 

• 3 standards for food nutrition fortifiers 

The standards of Food nutrition enhancer casein phosphopeptide (GB 31617-2014), Food nutrition enhancer carbonyl iron powder (GB 29212-2012), and Food nutrition enhancer inositol (cyclohexyl alcohol) (GB 1903.42-2020) will be modified. 

For more information, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

On 29 June 2023 the Korean National Institute of Environmental Research (NIER) announced that the evaluation of the registered biocidal product application is scheduled to be conducted. 

In relation to this, NIER posted guidelines for naming biocidal products for the purpose of registration application. 

Guidelines for naming biocidal products: 

1. The product name should be displayed in Korean on the outer surface of the product, excluding special characters. If Chinese characters or foreign languages are displayed along with Korean, the size of Korean letters should be larger. 

2. The product name should be displayed according to the biocidal product name indicated in the approved notification for biocidal products, following the format specified in Annex No. 24 of the enforcement rules. If there are multiple product names, one representative name should be written on one side of the approval notification, and the remaining names should be listed separately. 

3. To prevent confusion or the use of exaggerated names that may mislead consumers about the actual effects or potential risks associated with product use, product names should not cause confusion with other products or use exaggerated terminology. 

4. The product label should include clear and easily understandable information, including the product name, biocidal product type, biocidal substance (name and composition ratio by weight (%)), expiration date, statements regarding effectiveness, precautions for use, and other relevant information, in order to facilitate product labelling and advertising. 

According to the news published on https://www.meconomynews.com/ in February 2023, the deletion of regulations related to natural and organic cosmetics, which the Ministry of Food and Drug Safety included in the top 100 regulatory innovation tasks in August 2022, is on its way to becoming a reality. 

Korea Cosmetics Association (KCA), which announced a regulatory innovation plan for the growth of cosmetics in Korea, announced on the 17th of February a proposal to delete the Natural and Organic Cosmetics Act and abolish the government-led certification system. The related content has already been discussed with the Ministry of Food and Drug Safety since 2022, and it is expected that the law will be revised this year. 

According to the KCA, Korea is the only country in the world that regulates natural or organic cosmetics and operates a certification system at the government level. World-renowned ECOCERT in France, BDIH in Germany, and Soil Association in the UK are all private certifications. 

Another problem is that products that do not meet the standards of the Ministry of Food and Drug Safety cannot use the same marketing words and phrases in Korea even if they are certified by overseas certification agencies that are highly recognized in the world. 

Even if a company marks, advertises, and sells natural or organic cosmetics with global certification in overseas markets, it must mark, advertise, and sell them as general cosmetics in Korea without informing consumers of the differentiated characteristics of natural or organic cosmetics. 

Accordingly, the KCA association proposed to the Ministry of Food and Drug Safety to abolish the certification system recognized by the Ministry of Food and Drug Safety and revise the law that meets the market's autonomy, along with some revisions to the Cosmetics Act, which acts as natural or organic regulations. 

A KCA official told Meconomynews that "The government doesn’t have to regulate these certifications. We need to convert government-led certification of natural or organic cosmetics to private-led to facilitate market changes, reduce industry burdens such as duplicate certification, and secure market autonomy so that K-beauty can respond quickly to global trends and consumer needs." 

In Japan, the classification of substances according to the Japan GHS is overseen by three key ministries: the Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW), and the Ministry of Environment (MOE). These ministries are responsible for categorizing substances, and their classifications serve as a reference for companies when preparing GHS labels and Safety Data Sheets (SDSs).

On 29 June 2023, Japan’s National Institute of Technology and Evaluation (NITE) announced the classification listings for 170 substances (47 newly classified and 123 reclassified substances) based on the JIS Z 7252-2019 standard that adopts the sixth revised edition of the UN Globally Harmonized System (GHS) of classification and labelling of chemicals. The updated list consists of a total 3,327 substances.

Some examples of the substances are:

All GHS-classified substances are searchable through the GHS Mixture Classification and SDS/Label Preparation Creation System (NITE-Gmiccs).

In June 2022 the Japanese Ministry for Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) together with the National Institute of Occupational Safety and Health (JNIOSH) and the National Institute of Technology and Evaluation (NITE) of Japan launched a project with the goal of collecting test results and hazard data on chemical substances from the private sector.  The data information will be collected by NITE via its online platform.

Since 2006 a government Globally Harmonised System (GHS) of classification and labelling of chemicals project has been run by the MHLW, METI, MOE, and other relevant ministries to implement classification of chemical substances. So far GHS classification results for 3,300 substances have been published based on the knowledge of experts who use evaluation documents and books prepared by public institutions such as international organizations and major countries as basis information for classification. It is the hope that the new project will enhance communication on hazards from private business operators and that the hazards of currently unclassified substances and substances whose hazards have not been determined due to lack of information will be properly understood.

On 1 June 2023, NITE changed some requirements for companies voluntarily submitting chemical hazard information, to improve risk management in the workplace. The changes are:

1. Test information sourced from non-GLP (Good Laboratory Practise) laboratories will now be accepted by the project. The following requirements must be met for test reports to be regarded extremely dependable.

• Physico-chemical hazards: Tests carried out in accordance with the test procedures outlined by international organisations and standard organisations like the International Organization for Standardization (ISO), Japanese Industrial Standards (JIS), and United Nations Recommendations on the Transport of Dangerous Goods (UNRTDG).
• Hazardous to human health: The test substance has a certain level of purity in accordance with internationally recognized test methods such as OECD test guidelines (preferably conducted in a GLP-compliant test facility).
• Environmental hazards: The test substance has a certain level of purity in accordance with internationally recognized test methods such as OECD test guidelines (preferably conducted in a GLP-compliant test facility).

2. Companies had the possibility to notify NITE of their intention to provide information by 30 June 2023 but were not required to do so.

3. NITE will advise companies on how to submit documents of 400 megabytes (MB) or more.

4. If a company chooses to submit information, it must do so by 31 October 2023, using the NITE platform.

In addition to test information, this project also collects safety data sheets (SDS) that reflect GHS classification results using test information. Submission of an SDS is not mandatory, but it will serve as a reference for actual classification in the government's GHS classification project. The provided SDS will be used as reference information in the GHS classification project by the government but will not be posted on the NITE website or made available to the public.

UPDATE: The registration is now open in AICIS Business Services.

The Australian Industrial Chemicals Introduction Scheme (AICIS) has announced that companies that plan to import or manufacture industrial chemicals for commercial purposes (including certain products intended to release industrial chemicals) after 31 August 2023 must renew their registration with the AICIS. The AICIS will open registration in their Business Services portal in the middle of August for the next AICIS registration year (from 1 September 2023 to 31 August 2024).

From 21 July 2023 the rules for importation and exportation of decabromodiphenyl ether (decaBDE), perfluorooctanoic acid (PFOA), its salts, and PFOA-related compounds in Australia will be amended. This was announced by the Australian Industrial Chemicals Introduction Scheme (AICIS) on 14 July 2023.

Australian importers and exporters of the above-mentioned chemicals must now receive annual authorisation from the AICIS before import/export. The new rule does, however, not apply if the chemicals are introduced only for research or analysis at volumes of 100 kg or less in an AICIS registration year (30 August to 1 September). A full list of the compounds that require authorisation and some exceptions as well as all information on how to apply for authorisation can be found here.

The changes will be made because these chemicals were added to Annex II of the Rotterdam Convention in October 2022. More information can be found here.

The AICIS’ Call for Information about the above-mentioned chemicals is still open. In the Call the AICIS is asking current and previous importers and exporters of the above-mentioned chemicals to submit information about their import or manufacture. Information can be submitted here until 15 September 2023.

The industrialized state of São Paulo, known for setting the environmental standards in Brazil, has taken a pioneering step in promoting sustainability within the mining sector. 

Starting from July this year, the decree number 67.409, issued on December 28, 2022, comes into effect in the state of São Paulo, establishing the requirement for a registry of companies that want to sell products and by-products - CADMINÉRIO and establishes procedures for their acquisition by the Government of the State of São Paulo. 

The measure is celebrated by the construction sector - sand and crushed rocks firstly - as it is seen as another step towards self-regulation, requiring that aggregates purchased and used in projects in the State of São Paulo be supplied by companies compliant with mineral, environmental, and tax regulations. 

Now, the sector's aspiration is that, in its regulation, transportation will also be required to comply with legal weight limits, a request the industry has been fighting for over the past few years. 

The Brazilian Association of Technical Standards (ABNT) released on July 3 of 2023, a significant update to the ABNT NBR14725 Standard, which governs the classification and labeling of chemicals. This update marks the most substantial revision of the standard in over a decade, bringing important changes that align Brazil's regulations with international standards, particularly the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). 

Key Changes and Enhancements: The updated ABNT NBR14725 Standard introduces several notable changes, aimed at improving chemical classification, labeling, and hazard communication. Let's explore some of the key updates: 

• Structural Reorganization: One of the prominent modifications is the reorganization of the standard's structure. Previously divided into four parts, the new version consolidates all the content into a single, more extensive and comprehensive section, making it easier for users to navigate and understand the requirements. 

• Alignment with GHS: The updated ABNT NBR14725 Standard is based on the seventh revision of the GHS Purple Book. By adopting this GHS version, Brazil's regulations now closely align with international standards, promoting consistency and harmonization in chemical classification and labeling practices. 

• New Hazard Classes: Two new hazard classes have been included in the classification system. The first is "Desensitized Explosives," which addresses substances that have been treated to reduce their explosive properties. The second is "Ozone Depleting," which focuses on chemicals that pose a risk to the ozone layer. 

• Modified Labeling Elements: The labeling requirements have been revised, with changes in hazard statements (H phrases) and precautionary statements (P phrases). New H and P phrases have been added, providing more specific information about potential hazards and necessary precautions. Existing phrases have also undergone modifications to enhance clarity and accuracy. 

• Communication of Hazard: The updated standard introduces new rules for labeling small packaging. These regulations ensure that even the smallest containers carry essential information about the hazardous nature of the contained substances, enhancing safety measures and risk awareness. 

• Revised Safety Data Sheet (SDS): The standard introduces a change in the terminology used for Safety Data Sheets (SDS). Formerly known as Material Safety Data Sheets (MSDS), they will now be referred to as SDS, aligning the Brazilian naming convention with international standards. The content and structure of SDS remain largely unchanged, maintaining the requirement of 16 sections, each providing crucial information about chemical properties, handling, and safety measures. 

Impact and Compliance: The update to ABNT NBR14725 has significant implications for companies handling chemicals in Brazil. Here are some key considerations: 

• Mandatory Updates: All companies are required to update their existing Safety Data Sheets (SDSs) to comply with the new standard. The change in document nomenclature necessitates revisions to ensure consistency and alignment with the updated requirements. Additionally, labels may need to be revised and updated to reflect the modified hazard statements and precautionary phrases. 

• Time and Cost Implications: Achieving compliance with the updated regulations may require additional investments in resources and expertise. Companies might need to allocate time and funds for training employees, acquiring specialized technologies, and reviewing and updating their SDSs and labels. The magnitude of these tasks will depend on the size of the company and the number of products in its portfolio. 

• Revised Classification: Due to changes in concentration limits, some products previously classified may no longer require classification under the updated standard. However, it's important to note that this change does not apply universally, except for the inclusion of the new hazard class "Desensitized Explosives." 

The updated ABNT NBR14725 Standard brings significant changes to the classification and labeling of chemicals in Brazil. By aligning with the 7th GHS revision and incorporating new hazard classes, the standard enhances hazard communication and harmonizes Brazil's regulations with international practices. Companies should promptly assess the impact of these changes, ensuring timely compliance with the updated requirements by reviewing and updating their Safety Data Sheets and labels. 

Access to the NBR 14725 standard is via the ABNT Catalog website, through the link: ABNT Catálogo (abntcatalogo.com.br)

Price to aquire the new regulation is R$ 244.10 reais (50 US$) and is available only in Portuguese.

The second draft amendment to Decree No. 38/2014/ND-CP on the Management of Chemicals Covered by the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction was published by the Ministry of Industry and Trade of Vietnam (MOIT) on May 5, 2023. 

The Draft suggests:  

• clarifying the definition of "designated chemical substances"  

• updating the current Chemical Weapons Convention provisions on the production of "designated chemical substances"  

• adding new provisions on exemptions from obtaining trade licenses and import/export permits based on concentration thresholds  

• adding provisions on the storage and use of such chemicals 

• standardizing the due dates for submitting various reports.  

The original draft amendment, which was released on June 9, 2022, has also undergone a lot of modifications. Comments on the Draft were welcome until May 31, 2023. 

On July 4, 2023, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published Circular 2/2023, Guidelines for Control of Cosmetic Products, which outright prohibits 19 ingredients, limits three others, and allows the use of two more.

The Guidelines for Control of Cosmetic Products in Malaysia are periodically reviewed and updated to reflect changes made to the ASEAN Cosmetic Directive (ACD) by the National Pharmaceutical Review Agency (NPRA). Both the 36th ASEAN Cosmetics Committee (ACC) meeting, which was conducted electronically on November 30 and December 1, 2022, and the 37th ACC meeting, which took place on May 8 and 9, 2023, had previously agreed to update some of the substances listed in Annex II (List of prohibited substances), III (List of restricted substances), VI (List of preservatives), and VII (List of UV filters) on the ACD.

In Circular 2/2023 19 substances are added to Annex II (Appendix A), i.e. banned.  The full list that is quite similar to EU Amendment to Annex II (DLI 2019/831, EU 2019/1966, and EU 202J/850).can be found here (in Malay). Cosmetics containing components that have been notified are allowed to be sold until May 8, 2025.

Beginning on May 8, 2025, the revision also permits the usage of two additional substances listed in the table below. The two substances have been added to the List of permitted preservatives (Annex VI) and the List of UV filters (Annex VII) respectively.

The updated list of ingredients with restricted concentration allowed in cosmetics as per Annex VI and VII

Three more chemicals, together with their concentration requirements and restrictions, were added to the list of prohibited substances (Annex III) by the NPRA:

For Salicylic acid, as of November 21, 2024, conditions of use and warnings must be stated on product labels.  Methyl-N-m ethyIanthranilate used in leave-on products is restricted from 8 May 2025. The restriction does not apply to products that make claims about secondary UV protection, such as moisturizing and skin-lightening products. Use of ammonium silver zinc aluminium silicate, which is allowed in deodorant (both spray and non-spray types) and foundation is restricted to 1% from 8 May 2025.

The updated list of ingredients with restricted concentration allowed in cosmetics as per Annex III (Appendix B)

All Cosmetic Notification Holders are recommended to make thoughtful arrangements to prevent any potential problems. The holders of cosmetic notifications are reminded to follow all guidelines and legal requirements as outlined in Regulation 18A of the Drugs and Cosmetics Control Regulations of 1984 and the Guidelines for Control of Cosmetics Products in Malaysia.

The Ministry of Health of Chile has taken a significant step in providing clarity for businesses dealing with chemicals by publishing a comprehensive white paper. This document aims to help companies understand how two distinct chemical lists, namely Decree 594/1999 and Resolution 777/2021, interact with each other. 

The guide explains that Decree 57/2019, mandated the development of a reference list for the classification of the most common chemicals. This reference list, now adopted by Resolution 777/2021 is primarily intended for chemical classification purposes, including GHS (Globally Harmonized System) and SDS (Safety Data Sheet) requirements. 

It is crucial to note that the older occupational health and safety regulation, Decree 594/1999, was designed with a different focus – that of assessing occupational exposures to chemicals. 

The new guide issued by the Ministry of Health is an attempt to resolve any confusion that may have arisen due to the presence of these two lists. As part of this effort, the guide includes an annex that facilitates a comparison between the substances listed in the decree (Decree 594/1999) and those listed in Resolution 777/2021. This comparison will help businesses and stakeholders understand the distinctions and similarities between the two lists and how they apply to different regulatory aspects. 

By providing this valuable resource, the Ministry of Health seeks to support companies in navigating the regulatory landscape effectively and ensuring the safe handling and management of chemicals in the workplace. 

The newly introduced Draft Regulation on Disinfectants in Chile aims to establish a comprehensive framework governing the registration, manufacture, importation, storage, distribution, and dispensing of disinfectants in any form. These disinfectants are designed for use on surfaces, inanimate objects, environments, water, fabrics, textiles, chemical products, and other materials whose mechanism of action is carried out through chemical reactions. Additionally, the regulation encompasses disinfectant devices that rely on physical action for their effectiveness.

While the regulation's scope initially appears broad, there are equally broad exemptions that clarify certain areas not covered by its provisions. Disinfectants for use on the skin of individuals as pharmaceutical products or cosmetics, as well as those intended for animal consumption or as additives in food, fall under these exemptions. Medical devices, descaling agents that do not claim effectiveness on biofilm or microorganism elimination, and surface cleaning products that do not contain active ingredients known for regulated actions are also exempted from the regulation.

The draft regulation demonstrates a comprehensive approach, covering numerous aspects of disinfectant regulation. It addresses product registration, manufacturing standards, importation controls, storage requirements, and guidelines for packaging and labeling. In line with global best practices, the regulation adopts the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for substances falling within its scope.

Public participation and feedback are vital in shaping the final regulation. To ensure transparency and accountability, a 60-day public comment period commenced on July 3rd, following the notification to the World Trade Organization (WTO). This period allows stakeholders, including experts, industry representatives, and the general public, to provide valuable insights and perspectives on the proposed regulation, thereby contributing to its refinement.

As the draft regulation progresses through the consultation period, it is expected to undergo further analysis and evaluation. By incorporating stakeholder feedback and expert input, Chile aims to fine-tune the regulation, enhancing its effectiveness, practicality, and alignment with the needs of the local context.

In a move towards environmental preservation, the National Government of Colombia has implemented a groundbreaking law to reduce and eliminate the use of mercury in industrial activities. The decision, in accordance with Article 3 of Law 1658 of 2013, marks a significant milestone in the nation's commitment to safeguarding the environment and public health.

The law, aptly titled "Reduction and Elimination of Mercury Use," was enacted with the collaboration of key ministries responsible for environment, energy, health, and labor that jointly worked to formulate regulatory measures to ensure the safe and sustainable reduction of mercury usage across various industries.

One of the central provisions of the law was the complete eradication of mercury use on national soil within ten (10) years for all industrial and productive processes. For the mining sector, the timeline was even more ambitious, with a maximum period of five (5) years for total elimination. The National Government has pledged full support, providing the necessary technological instruments and engaging with responsible entities and organizations dedicated to preserving the environment and promoting sustainable development.

As of July 15, 2023, the use of mercury has been strictly prohibited in all industrial and productive processes nationwide. This sweeping ban includes importation and exportation processes to and from the country, ensuring that no mercury-laden goods enter or leave the national territory.

Mercury, known for its hazardous effects on ecosystems and human health, has been a significant concern for environmentalists and public health advocates alike. By taking this bold step to restrict its usage, Colombia seeks to combat the detrimental impact of mercury on the environment, wildlife, and human populations.

The National Government encourages cooperation and compliance from all stakeholders, urging industries to explore mercury-free alternatives and embrace cleaner, greener technologies. As the nation embarks on this transformative journey, it sets a promising precedent for other countries to follow in the pursuit of a healthier and more sustainable planet.

Through Resolution 395/2023, Colombia solidifies technical regulations on the environmental aspects of phosphorus content and promote surfactant biodegradability in detergents and soaps, making them permanent.

The resolution signifies a pivotal step in Colombia's commitment to environmental protection and promoting eco-friendly consumer products. By establishing maximum limits on phosphorus content, the regulation aims to mitigate the environmental impact of detergents and soaps, particularly regarding water pollution and ecosystem degradation. By limiting the phosphorus levels, Colombia seeks to reduce the risk of eutrophication, a process that can harm aquatic life and compromise water quality. 

Additionally, the regulation emphasizes the biodegradability of surfactants, which play a crucial role in detergents and soaps. By setting standards for biodegradability, Colombia aims to ensure that these products break down effectively after use, minimizing their long-term environmental impact. Biodegradable surfactants contribute to wastewater treatment processes, allowing for cleaner water discharge and reduced ecological harm. 

By making these technical regulations permanent, Colombia aims to create a stable and consistent framework for the production, importation, and use of detergents and soaps. This permanence provides manufacturers and stakeholders with clear guidelines to follow, encouraging the development and adoption of sustainable practices throughout the industry. 

By adopting stringent standards on phosphorus content and surfactant biodegradability, Colombia demonstrates its commitment to global environmental objectives and contributes to the collective goal of preserving the planet for future generations. 

Peru is taking significant steps to regulate the import and production of fertilizers, aiming to enhance sustainable soil management, promote domestic agricultural competitiveness and sustainability, and improve food and nutrition security while ensuring safety, quality, and efficient use of these substances. A notified draft regulation has been proposed, which aims to establish provisions that govern the entire life cycle of fertilizers and similar substances, with a focus on minimizing adverse health and environmental impacts.  

The primary objective of the proposed regulation is to protect farmers and agricultural workers by ensuring the safety, quality, and efficient use of fertilizers. By establishing stringent guidelines for importers and manufacturers, Peru seeks to reduce the potential health risks associated with the use of fertilizers. The regulation aims to enhance farmer awareness and provide them with safe and reliable products, thereby safeguarding their well-being and promoting sustainable agricultural practices. 

Peru recognizes the importance of promoting the competitiveness and sustainability of its domestic agriculture sector. The proposed regulation seeks to create a level playing field for farmers and increase their access to high-quality fertilizers. By encouraging sustainable soil management practices, the regulation aims to enhance soil fertility, reduce environmental degradation, and preserve natural resources. These measures will contribute to long-term agricultural productivity, economic growth, and the country's overall food security. 

Food and nutrition security is a pressing concern globally, and Peru is no exception. The proposed regulation addresses this urgent problem by focusing on the efficient use of fertilizers to improve crop quality and yield. By optimizing the nutritional value of agricultural products, Peru aims to enhance the availability of diverse and nutritious food for its population. This regulation will help combat malnutrition, promote healthier diets, and contribute to the overall well-being of the nation. 

The proposed regulation recognizes the potential adverse health and environmental impacts associated with the use of fertilizers. To mitigate these risks, the regulation sets forth strict standards for import, production, labeling, handling, storage, and distribution of fertilizers. Compliance with these standards will help ensure that fertilizers meet safety and quality requirements, minimizing the presence of harmful substances in food and reducing environmental contamination. By adopting responsible practices, Peru aims to safeguard human health, protect ecosystems, and preserve water resources and biodiversity. 

The draft resolution is in its consultation phase since June 2023 for a period of 90 days and will also be analyzed by the Andean Community (CAN) and the World Trade Organization (WTO). 

Mexico's Federal Commission Against Health Risks (COFEPRIS) has taken a significant step in ensuring the safe management and tracking of chemical precursors and essential chemicals within the country. The introduction of the online Integral System for Chemical Substances (SISUS) marks a crucial milestone in regulating the movement of these substances and promoting public health and safety.  

Earlier this year, Mexico made a groundbreaking change to its laws by establishing the Integral System for Chemical Substances (SISUS). The primary goal of SISUS is to enable better tracking and control of chemical precursors and essential chemicals, which are often used in the production of various goods, including pharmaceuticals, chemicals, and industrial products. These substances, if not appropriately managed, could pose health and security risks, leading to potential hazards like drug production and illicit activities. 

To ensure the seamless functioning of SISUS, the Mexican government now requires companies to report each shipment involving these regulated substances within 24 hours of their movement. This stringent regulation aims to prevent the misuse and illicit distribution of these chemicals, ultimately safeguarding public health and national security. 

Third Round of Registrations: A Key Step Towards Full Implementation 

While the SISUS platform is not yet fully operational, Mexico's government is committed to moving forward with its implementation. As part of the full implementation plan, COFEPRIS is conducting the third round of registrations for companies to become registered entities within the SISUS platform. This means that companies actively involved in handling chemical precursors and essential chemicals in Mexico must register themselves in the SISUS database. 

By mandating registration, the Mexican government aims to create a comprehensive database of companies dealing with these substances, facilitating improved monitoring and tracking capabilities. This database will provide authorities with real-time information on the movement and usage of regulated chemicals, empowering them to respond swiftly to potential threats and enforce necessary safety measures. 

Companies' Obligations and Responsibilities 

For companies involved in the production, import, export, or distribution of chemical precursors and essential chemicals in Mexico, registration in the SISUS platform is no longer optional; it is an imperative regulatory requirement. Failure to comply with this mandate could result in severe penalties, including fines and potential business disruptions. 

Companies that have not been covered by the first two rounds of registrations should closely monitor COFEPRIS's announcements for the release of the new list of companies identified for registration in this third round. It is crucial to remain proactive and initiate the registration process promptly to ensure compliance with the new regulations. 

The introduction of Mexico's online Integral System for Chemical Substances (SISUS) represents a crucial step towards ensuring the safe and responsible management of chemical precursors and essential chemicals within the country. As COFEPRIS conducts its third round of registrations for companies, it is essential for relevant entities to take immediate action and comply with the new regulations to avoid penalties and ensure the seamless functioning of the SISUS platform. Ultimately, the successful implementation of SISUS will contribute to a safer, more secure, and healthier environment for Mexico and its citizens. 

In a recent move to provide clear guidelines and dispel confusion in the cosmetics industry, Mexico's regulatory authority for health products, COFEPRIS (Federal Commission for Protection against Sanitary Risk), has published a special Circular addressing the implementation of the new standard on Good Manufacturing Practices (GMP) for cosmetics products, known as NOM-259-SSA1-2022. The circular aims to offer much-needed clarity and insights into the application of the new regulations to ensure a smoother transition for businesses in the cosmetics sector.

Streamlined Entry Process for Imported Cosmetics

One of the key highlights of the new Circular is the streamlining of the entry process for imported cosmetic products into Mexico. As per the guidelines, imported cosmetics will no longer require prior sanitary import permits from COFEPRIS, thereby simplifying the importation process and potentially reducing administrative burdens for businesses.

Voluntary Certificate of GMP for Cosmetics Products

The Circular clarifies that while compliance with the NOM-259 standard is mandatory for all cosmetics products in the Mexican market, obtaining a Certificate of GMP for Cosmetics Products is not obligatory. In other words, manufacturers are not compelled to obtain this certificate, though they have the option to do so voluntarily. This offers flexibility to businesses, allowing them to decide whether obtaining the certificate aligns with their objectives and strategies.

Long-Term Validity of Certificates for Export in Compliance with GMP

For those manufacturers who choose to pursue the Certificate of GMP for Cosmetics Products, the Circular provides reassurance as it states that such certificates will remain valid for a period of five (5) years. This long-term validity period ensures that businesses can plan for export activities with confidence and stability, reducing the need for frequent certificate renewals.

Protection of Pre-NOM-259 Certifications

The Circular clarifies that cosmetic products certified for export prior to the implementation of the NOM-259 standard will remain unaffected and need not undergo any modifications. This provision offers assurance to manufacturers who had previously obtained certifications, ensuring that their products can continue to be exported without disruption.

COFEPRIS' Focus on Mexican Standards

In a notable decision, COFEPRIS emphasizes that it will apply Mexican standards, including NOM-259 and others, for cosmetics regulations. The Circular clarifies that COFEPRIS will not use ISO 22716, a widely recognized international standard for cosmetics GMP, as it falls outside the agency's sphere of competence. This decision underscores COFEPRIS' commitment to adopting and enforcing locally relevant and tailored regulations.

With the provided this Circular, COFEPRIS aims to address various questions and uncertainties surrounding the new GMP standard for cosmetics products, ensuring clarity and streamlined processes for businesses operating in the cosmetics industry in Mexico. 

Peru is taking significant steps to regulate the import and production of fertilizers, aiming to enhance sustainable soil management, promote domestic agricultural competitiveness and sustainability, and improve food and nutrition security while ensuring safety, quality, and efficient use of these substances. A notified draft regulation has been proposed, which aims to establish provisions that govern the entire life cycle of fertilizers and similar substances, with a focus on minimizing adverse health and environmental impacts.  

The primary objective of the proposed regulation is to protect farmers and agricultural workers by ensuring the safety, quality, and efficient use of fertilizers. By establishing stringent guidelines for importers and manufacturers, Peru seeks to reduce the potential health risks associated with the use of fertilizers. The regulation aims to enhance farmer awareness and provide them with safe and reliable products, thereby safeguarding their well-being and promoting sustainable agricultural practices. 

Peru recognizes the importance of promoting the competitiveness and sustainability of its domestic agriculture sector. The proposed regulation seeks to create a level playing field for farmers and increase their access to high-quality fertilizers. By encouraging sustainable soil management practices, the regulation aims to enhance soil fertility, reduce environmental degradation, and preserve natural resources. These measures will contribute to long-term agricultural productivity, economic growth, and the country's overall food security. 

Food and nutrition security is a pressing concern globally, and Peru is no exception. The proposed regulation addresses this urgent problem by focusing on the efficient use of fertilizers to improve crop quality and yield. By optimizing the nutritional value of agricultural products, Peru aims to enhance the availability of diverse and nutritious food for its population. This regulation will help combat malnutrition, promote healthier diets, and contribute to the overall well-being of the nation. 

The proposed regulation recognizes the potential adverse health and environmental impacts associated with the use of fertilizers. To mitigate these risks, the regulation sets forth strict standards for import, production, labeling, handling, storage, and distribution of fertilizers. Compliance with these standards will help ensure that fertilizers meet safety and quality requirements, minimizing the presence of harmful substances in food and reducing environmental contamination. By adopting responsible practices, Peru aims to safeguard human health, protect ecosystems, and preserve water resources and biodiversity. 

The draft resolution is in its consultation phase for a period of 90 days and will also be analyzed by the Andean Community (CAN) and the World Trade Organization (WTO). 

In July 2022, it was published in the Diario Oficial de la Federación (DOF) in Mexico a regulation about good manufacturing practices for cosmetic products. This regulation establishes good manufacturing practices (GMP) for cosmetic products, as well as the organizational manual of the Ministry of Health. 

The standard states: "Considering that every company or establishment dedicated to the production of cosmetic products has the responsibility to guarantee that the products it manufactures do not pose risks to the consumer's health, it must have a system for prevention, control, and verification of sanitary quality in order to ensure that cosmetic products are safe." 

It further explains that GMP is a set of guidelines that must be applied in the cosmetic product manufacturing process.The GMP standard for cosmetic products was developed taking into account the specific needs of this sector.

The objective of this regulation is to provide a description of the basic requirements that must be followed throughout the process, such as the conditions that the personnel, production, control, storage, packaging, and other activities must meet. Another goal of this standard is to ensure that the manufactured products meet sanitary quality standards, can be consumed safely, and are effective for their specific cosmetic applications. 

The regulation emphasizes that companies have the responsibility to guarantee to consumers that the manufactured product does not pose a health risk. GMP serves as the sanitary foundation under which any company involved in the process and handling of cosmetics must operate, ensuring that even the simplest operation throughout the manufacturing process of a cosmetic product is carried out under conditions that ensure its sanitary quality. 

Furthermore, the regulation states that due to the continuous evolution of the cosmetics industry, it is necessary to take actions that protect the health of the population and, at the same time, prevent Mexico from lagging behind in this field. 

The regulation came into force in May 2023.

Link in Spanish: DOF - Diario Oficial de la Federación