GPC Newsletter Sep-2023

Are you ready for the next big thing in cosmetics regulation? The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has arrived, reshaping the landscape of cosmetic oversight in the United States. This groundbreaking legislation, enacted on December 29, 2022, represents a pivotal moment in the history of cosmetics regulation, with the aim of strengthening consumer safety and enhancing the integrity of the industry. Here's everything you need to know about MoCRA.

Key Provisions and Deadlines: MoCRA's Impact on Cosmetics

As MoCRA takes centre stage, it brings with it a series of obligations and deadlines that will reshape the cosmetic industry in the United States. Are we ready to meet these new requirements? Let's take a closer look at the key provisions and deadlines.

MoCRA focuses primarily on the regulation of cosmetic products, which are defined as "a preparation of cosmetic ingredients with a qualitatively and quantitatively defined composition for use in a finished product". It does not cover over-the-counter (OTC) medicines that make cosmetic claims, such as anti-dandruff shampoos, moisturisers/make-up marketed with sun protection claims, etc. Instead, these products are subject to OTC drug regulations. However, it is worth noting that certain provisions of MoCRA relating to fragrance allergen disclosure and professional use labelling remain applicable in these cases.

1. Facility Registration (Deadline: December 29, 2023)

Under MoCRA, all existing cosmetic facilities must register with the U.S. Food and Drug Administration (U.S. FDA) by December 29, 2023. New facilities must complete their registration within 60 days of commencing operations or by February 27, 2024, whichever is later. Moreover, these registrations must be renewed every two years, ensuring ongoing compliance. A draft guidance on registration and listing of cosmetic product facilities and products can be found here.

2. Product Listing (Deadline: December 29, 2023)

Responsible persons (RPs), which include manufacturers, packers, or distributors whose names appear on cosmetic product labels, are required to list each cosmetic product and its ingredients with the U.S. FDA by December 29, 2023. For products introduced to the market after MoCRA's enactment, the RPs must submit product listings within 120 days of marketing or within 120 days of December 29, 2023, whichever is later. Additionally, RPs must update this information annually, promoting transparency and accuracy.

3. Safety Substantiation (Deadline: December 29, 2023)

 Ensuring the safety of cosmetic ingredients and intended product use is a fundamental responsibility of RPs under MoCRA. They must maintain adequate safety substantiation for their products or have their product safety evaluated by a qualified expert before the impending deadline of December 29, 2023. Products lacking safety substantiation will be considered misbranded and adulterated, reinforcing the commitment to consumer safety. More resources on cosmetics safety substantiation can be found here.

4. Labelling (Deadline: December 29, 2024)
MoCRA imposes several labelling requirements with the primary goal of enhancing consumer information and safety. Cosmetic product labels must now prominently display a domestic address, domestic phone number, or electronic contact information where Responsible Parties (RPs) can receive adverse event reports. Additionally, there is a new mandate to clearly label fragrance allergens. According to MoCRA, the U.S. FDA is tasked with the responsibility of issuing the list of fragrance allergens within a period of eighteen months from the enactment of the legislation, and the final ruling will be issued precisely one hundred and eighty days after the public comment period concludes. Furthermore, for professionally used cosmetics, it is obligatory to feature a conspicuous statement indicating that these products are exclusively intended for use by licensed professionals, while still adhering to the existing cosmetic labelling requirements.
5. Cosmetic Good Manufacturing Practices (Deadline: December 29, 2025)

The introduction of Good Manufacturing Practises (GMPs) is a crucial aspect of MoCRA. These practices, aligned with national and international standards, are designed to protect public health by preventing the adulteration of cosmetic products. MoCRA empowers the U.S. FDA to inspect facilities and access records, ensuring GMP compliance. Within two years of enactment, the FDA will publish a Notice of Proposed Rulemaking for Cosmetic GMP, with the final ruling due within three years after enactment.

6. Adverse Event Reporting

RPs are required to promptly report any "serious adverse event" related to a cosmetic product to the U.S. FDA within fifteen working days of receiving the report. Additionally, for one year after the initial submission, RPs must provide new, and material medical information related to the initial report within fifteen working days of receipt. This ensures that adverse events continue to be monitored and reported with RPs required to keep records for six years.

7. Records

Under MoCRA, the U.S. FDA now possesses the authority to conduct in-person audits of various records related to cosmetic products if there are concerns about serious health issues or adverse events associated with the product or its ingredients.

8. Mandatory Recall Authority

In cases where the U.S. FDA determines a reasonable probability that a cosmetic is adulterated, misbranded, or poses serious adverse health consequences or death, the FDA can compel RPs to cease distribution or initiate a recall voluntarily, further bolstering consumer protection.

Conclusion

A new era of safety and transparency in the cosmetics industry is set to begin with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). As the deadlines approach, industry stakeholders and consumers alike must prepare for these transformative changes, ultimately contributing to safer and more reliable cosmetic products for all.

On 30 August 2023, the European Chemicals Agency (ECHA) published the sixth revised guidance addressing efficacy assessment and evaluation of biocidal products on its web page. The revised guidance covers the efficacy testing requirements and acceptance criteria for preservatives for liquid cooling and processing systems (product type 11) and slimicides (product type 12).

ECHA’s guidance on the Biocidal Products Regulation

ECHA's guidance on biocides legislation describes how to comply with the information requirements of the Biocidal Products Regulation (Regulation (EU) 528/2012) (BPR) and how to carry out the required evaluations. It also explains the guiding principles for the evaluation of applications to be carried out by the authorities.

Changes in the sixth revised guidance

In the sixth version of the Guidance on the BPR the following sections and appendices have been added:

• PT11 - Section 5.5.11 PT11 Preservatives for liquid-cooling and processing systems

• PT12 - Section 5.5.12 PT12 Slimicides

• Appendix 25 – References to chapters PT11 and PT12

• Appendix 26 – Definitions for PT11 and PT12

• Appendix 8 has been updated by adding the commonly used methods for PT11 and 12

The following corrections have been made, along with some minor editorial corrections relating to spelling.

• Appendix 3 (the Key for Table 42 section has been corrected)

• Appendix 4: PT 3 Teat disinfection (yeasts pre/post-milking - phase 2, step 2 test requirement has been changed from “If claimed” to “Optional”)

The European Chemicals Agency (ECHA) has announced that IUCLID 6 will replace the REACH-IT online dossier preparation functionality. IUCLID 6 is offered via the ECHA Cloud Services (IUCLID Cloud).

Changes

In 2024 the following REACH-IT online dossier preparation functionality will be removed:

• Downstream user notification of authorised uses

• Classification and labelling notifcations

Timeline

In January 2024 the initial online dossier preparation will be disabled. It will still be possible to update existing online notifications until April 2024. There is no deadline for the transition from the REACH-IT online dossiers to IUCLID dossiers. An update to an existing online dossier from REACH-IT can be prepared by downloading an old dossier from REACH-IT at any time and converting the dossier file to a dataset in IUCLID.

IUCLID

IUCLID (International Uniform Chemical Information Database) is a software application designed to record, store, maintain and exchange data on the intrinsic and hazard properties of chemical substances or mixtures, their uses of these substances and the associated exposure levels. It is a key software application for both regulatory authorities and the chemical industry where it is used in the implementation of various regulatory programmes.

ECHA develops and maintains the IUCLID software and the underlying format in collaboration with the OECD. This collaboration enables the management of the IUCLID format with the aim of harmonising as much as possible the way in which data on chemicals are collected and exchanged in regulatory settings.

IUCLID 6 on ECHA Cloud Services (https://ecs.echa.europa.eu/cloud/home.html) is free of charge and always up to date.

On 1 September 2023, the European Chemicals Agency (ECHA) published 6 new proposals to identify Substances of Very High Concern (SVHC). The consultation is open until 16 October 2023.

Substances of Very High Concern

SVHCs are substances that can have serious and often irreversible effects on human health and the environment. A substance that is identified as an SVHC will be added to the Candidate List for eventual addition to the Authorisation list. As of 14 June 2023, the Candidate list has 235 entries, some are groups of chemicals, so the overall number of impacted chemicals is higher. The Authorisation list has 59 entries. If a substance is on the Authorisation list, its use is prohibited unless the European Commission grants authorisation for continued use.

The proposed SVHCs

The six proposals that the ECHA is looking for comments on are listed in the table below:

Making Comments

The identification of SVHCs is based on the hazard properties of a substance. All interested parties are invited to submit comments during the. Comments are particularly welcome on:

• The identity of the substance (i.e. on the substance name/EC number/CAS number/molecular structure etc.)

• Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) properties and on other properties that give rise to equivalent levels of concern.

Comments for each substance can be made here by following the link to details and choosing making comments.

Comments relevant for the identification of a substance as an SVHC will be forwarded to the Member State Committee (MSC) which will assess whether the substance should be identified as an SVHC.

On 25 September 2023, the European Commission adopted new rules under EU-REACH to restrict microplastics intentionally added to products. The amendment, Commission Regulation (EU) 2023/2055, to Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was published in the Official Journal of the European Union on 27 September 2023 and will enter into force on 17 October 2023.

The new rules prohibit the sale of microplastics as such and of products to which microplastics have been intentionally added and that release those microplastics when used. The restrictions are expected to prevent the release of about half a million tonnes of microplastics to the environment over the next 20 years.

Why are restrictions for microplastics needed?

Microplastics are a concern because once they are released into the environment, microplastics do not undergo biodegradation and are virtually impossible to eliminate. They accumulate in animals, including fish and shellfish, ultimately leading to their ingestion by humans when these animals become part of the food chain.

Microplastics have been detected in marine, freshwater, and terrestrial ecosystems, as well as in food and drinking water supplies Their continued release contributes to permanent pollution of our ecosystems and food chains.  Laboratory studies have established a connection between exposure to microplastics and a variety of adverse ecological and toxicological effects on living organisms.

A significant part of microplastic pollution arises unintentionally, from processes such as the breakdown of larger pieces of plastic waste, wear and tear of tires and road markings, or the washing of synthetic textiles. Nevertheless, minuscule particles of synthetic or chemically altered natural polymers are also intentionally produced for direct use or inclusion in various products.

Definition of microplastics

In the adopted restriction the definition of microplastics covers all synthetic polymer particles smaller than 5 millimetres that are organic, insoluble and resist degradation as well as fibre-like particles below 15 mm in length. However, particles smaller than 0,1 μm (0,3 μm in length for fibre-like particles) will not be taken into account.

Affected products

The following are some common products that will be affected by the restriction:

• The granular infill material used on artificial sport surfaces which represents the largest source of intentional microplastics in the environment.

• Cosmetic products where microplastics are added for purposes such as exfoliation (microbeads) or to obtain specific textures, fragrances, or colours.

• Detergents and fabric softeners

• Glitter

• Fertilisers

• Plant protection products

• Toys

• Medicines and medical devices

Derogated products

The following products can continue to be sold as they are derogated from the sale ban:

• Products used at industrial sites.

• Products that contain microplastic but do not release them during use, e.g. construction materials.

• Products already such as medicinal products, food and feed that are already regulated by other EU legislation.

Manufacturers of such products will be required to provide instructions on how to use and dispose of the product to prevent microplastics emissions. Additionally, they must report the estimated microplastics emissions annually.

Products in which microplastics are not intentionally added but are inadvertently present, such as in sludge or compost, are not in the scope of the restriction.

Transitional periods

The first measures will come into effect on 15 October 2023, such as a ban on the sale of cosmetics containing microbeads, as their use is already being phased out, as well as loose plastic glitter. As for other cosmetics products, a transitional period ranging from 4 to 12 years will apply. The specific duration of the transitional period will depend on factors such as the complexity of the product, the need for reformulation, and the availability of suitable alternatives.

The ban on infill material for sport pitches will come into effect after 8 years. This timeframe offers pitch owners and managers enough time to transition to alternative materials and allowing most existing sports pitches to naturally complete their lifespan.

The complete Commission Regulation (EU) 2023/2055 that amends the REACH regulation as regards synthetic polymer particles can be found here.

On 5 September 2023, the UK Health and Safety Executive (HSE) announced the publication of new guidance on how to meet aspects of the residue data requirements. The new guidance will apply from 1 January 2024. The guidance is referred to as the ‘GB Extrapolation Guidance 2024’ and only applies to Great Britain (England, Scotland, and Wales).

GB Extrapolation Guidance 2024

The purpose of GB Extrapolation Guidance 2024 is to advice applicants on the requirements for residue trials data to support the registration of plant protection products (PPP) and for setting maximum residue levels (MRLs) in Great Britain (GB). The guidance sets out the technical requirements in the following areas:

• the data and information requirements for residue trials, e.g. trial location, number of residue trials, etc

• the comparability of residue trials and deviations from Good Agricultural Practice (GAP)

• the extrapolation of residue data for products of plant and animal origin

• the establishment of maximum residue levels (MRLs)

The preview of the GB Extrapolation Guidance 2024 can be found here. It replaces the previous version of the extrapolation document SANCO 7525/VI/95 Rev. 10.3.

India is a party to the 1988 UN Convention against Illicit Traffick in Narcotic Drugs and Psychotropic Substances (NDPS). The convention regulates 33 chemicals, but so far India has only regulated 27 of these for international trade under the Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013 (RCS). 

Chemicals not controlled under RCS  

The 6 chemicals that India does not regulate are: 

• Acetone 

• Ethyl Ether 

• Hydrochloric Acid 

• Piperidine 

• Sulfuric Acid  

• Toluene 

Since these chemicals are regulated internationally under the NDPS, many countries are getting no objection against Pre-Export Notifications (PENs) issued to them before issuing an Export Authorization, and in cases of import, some countries may reject the import consignment because they don't have a No Objection Certificate (NOC) from the exporting country. Consequently, trade may encounter numerous challenges when it comes to clearing import and export shipments containing these chemicals. 

Notice from Central Bureau of Narcotics 

To promote smooth trade involving these 6 chemicals around the world, the Central Bureau of Narcotics (CBN) released a public notice on August 08, 2023. In this notice, they suggested that companies that are encountering trade-related difficulties should adopt a voluntary code of approach by reaching out to the CBN via e-mail at narcommr@cbn.nic.in (with a copy sent to iccmumbai@iccmail.in). On a case-by-case basis, companies can provide minimal documentation, including the Know Your Customer (KYC) for to get a letter or communication saying these chemicals are not regulated in India. 

Voluntary practice 

Members of the Indian Chemical Council are encouraged to adopt voluntary practice when it comes to importing and exporting these six chemicals, aiming to mitigate any potential challenges in the global trade of these substances. 

On 13 September 2023, the Indian Department of Chemicals and Petrochemicals notified the World Trade Organization (WTO) of Quality Control Orders (QCOs) for eight substances. The final day for comments is 60 days from the notification.

Substances included in the QCOs

The table below lists the eight substances included in the notified QCOs. There are six chemicals, one insecticide, and one fungicide. The locally manufactured or imported quantities of the substances specified in column 1 of the table must comply with the corresponding Indian Standard listed in column 2 bearing the title of the Indian Standard listed in column 3. The substances must bear the Standard Mark under a licence from the Bureau of Indian Standards in accordance with Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The use of standard mark is governed by the provisions of Bureau of Indian Standards Act, 2016 and the Rules and Regulations made thereunder.

The QCOs do not apply goods or articles meant for export.

Timeline

The date of adoption of the 8 QCOs is yet to be determined. The QCOs will enter into force 6 months after the date of publication in the Official Gazette.

Areas of use

The table below shows the various applications and areas of use for the eight substances that are included in the notified QCOs.

On 31^st August 2023, the National Institute for Food and Drug Control of China (NIFDC) published the Technical Guidance Principles on Children Cosmetic Products. This guidance was enforced since 31^st August 2023. 

This guidance gives detailed information on the technical requirements of all materials to be prepared for submission. This includes the followings. 

• Product name. Product name should be composed of brand name, generic name, and attribute name.
• Product formula. Children cosmetic products should meet the requirements set in “rules on cosmetic registration / record filling management” and “cosmetic safety technical guidance”.
• Standards. The manufacturing process should comply with enforced standards. This includes sensory index, micro-biology, and Phys-chemical index, quality control measures, usage methods, safety warnings, and storage conditions. 
• Labels. Label should be in Chinese and include information as required by cosmetic regulation. 
• Test reports. 
• Safety evaluation. 
• Children cosmetics which are specially made for Chinese market. For such product, in addition to the above points, an illustration on the products which are specifically designed on the skin types and consuming requirements on Chinese children is required. 

Additionally, this guidance includes an annex of the possible allergenic fragrance components released by international authoritative organizations. For more information regarding China cosmetic compliance, please contact GPC via compliance@gpcregulatory.cn

On August 3, 2023, the Ministry of Environment (MOE) in South Korea announced that it will issue a preliminary legislative notice of draft partial amendments to the Enforcement Decree and Enforcement Rule on the Wastes Control Act and its implementing regulations. The MOE will hold a legislative preview for the amendments from August 4, 2023, to September 15, 2023.  

These amendments aim to rationalize regulations and unify the procedures for the collection, transportation, and disposal of waste, including hazardous chemicals, will be unified under the Waste Control Act. Related standards will be reorganized to prevent gaps in safety management, and related regulations such as electric vehicle waste batteries and carbon dioxide collection will be improved to reflect the improvement and supplementation requirements raised in the system operation process. This includes revitalizing the circulation of waste resources and expanding the use of new technologies. 

It is intended to unify the management system by including restricted substances, licensed substances, prohibited substances, and substances requiring preparation for accidents among hazardous chemicals in the waste classification system, and to clearly define that human secretion themselves are included in general medical waste. 

On July 10, 2023, the Ministry of Environment (MOE) of South Korea published an Administrative Notice of Partial Amendment to the Regulations on the Stipulated Quantities for Toxic Substances, Restricted Substances, Prohibited Substances, and Permitted Substances. The proposed amendment aims to set the upper and lower stipulated quantities for 6 types of new toxic substances.  

This is to prepare a specified quantity for each substance for classification (Group 1, Group 2, and Exemption) subject to submission of the Chemical Accident Prevention and Control Plan for changes such as additional designated toxic substances and specified quantity of previously designated substances due to the amendment of the Designation of Toxic Substances (National Institute of Environmental Research Notice No. 2023-21) published on June 1, 2023. 

In a significant move aimed at curbing environmental pollution, Japan has officially notified the World Trade Organization (WTO) of its intention to designate Perfluorohexane Sulfonate (PFHxS), its isomers, or salts as Class I Specified Chemical Substances on 1 September 2023. These substances will require special authorization for their manufacturing or importation within the country.

The decision, based on Article 24 of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc., will also entail a ban on several products if they incorporate PFHxS, its isomers, or their salts. The proposed date for adopting these measures is set for November 2023, with the entry into force scheduled for January 2024 for chemical substances and May 2024 for the products affected.

The following products will be prohibited from being imported when containing PFHxS, its isomers, or salts:

1. Water-repellent textiles and oil-repellent textiles.

2. Etching agents used for metal processing.

3. Etchants used in the manufacture of semiconductors.

4. Surface treatment agents for plating or related additives.

5. Antireflection agents used in semiconductor manufacturing.

6. Resists for semiconductors.

7. Water repellent, oil repellent, and fabric protection agents.

8. Fire extinguishers, fire-extinguishing agents, and fire-extinguishing foam.

9. Water-repellent clothes and oil-repellent clothes.

10. Water-repellent floor coverings and oil-repellent floor coverings.

The move is driven by concerns over the environmental impact of PFHxS, its isomers, and their salts, which are known for their non-biodegradability, high potential for bioaccumulation, and chronic toxicity. The decision aligns with resolutions made during the 10th Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants in 2022, emphasizing the need for international action against hazardous substances.

The public and stakeholders are invited to provide comments on these proposed measures within 60 days from the date of notification.

On 25 September 2023, the Australian Department of Climate Change, Energy, the Environment and Water (DCCEEW) opened consultations on the proposed scheduling decisions for brominated flame retardants (BFRs) under the Industrial Chemicals Environmental Management Standard (IChEMS). The consultations were notified to the World Trade Organization (WTO) on 27 September 2023.

The substances in question are all classified as Persistent Organic Pollutants (POPs) under the Stockholm Convention. These substances have the potential to inflict significant or irreversible damage to the environment unless they are appropriately controlled.

The consultations are open for feedback until 25 October 2023 and submissions can be made here. Providing feedback on the proposed decisions will help the Australian governments and businesses  manage the environmental risks associated with these chemicals.

Brominated Flame Retardants

Brominated flame retardants are mixtures of chemicals added to a wide range of products, including industrial products, to make them less flammable. They are commonly used in plastics, textiles, and electrical/electronic equipment.

The DCCEEW is seeking feedback on four proposed scheduling decisions covering a large number of brominated flame retardants. Three scheduling decisions are for Schedule 7 of the IChEMS Register and cover the following chemical classes and all their congeners. If adopted, the proposed decisions for these substances will apply from 1 July 2024. If adopted, the import, manufacture, use and export in Australia will be prohibited from 1 July 2024. Exceptions will apply for unintentional trace contamination, research, environmentally sound disposal, and for articles in use prior to the date of decision.

• Hexabromocyclododecane (HBCDD)

• Pentabromodiphenyl ether (pentaBDE) and tetrabromodiphenyl ether (tetraBDE)

• Octabromodiphenyl ether (octaBDE), heptabromodiphenyl ether (heptaBDE) and hexabromodiphenyl ether (hexaBDE)

The fourth decision covers the following chemical classes and their congeners. This decision concerns Schedule 6 of the register. If adopted this decision will apply from 1 July 2025 and will prohibit the import, manufacture, use and export in Australia.

• Decabromodiphenyl ether (decaBDE) and nonabromodiphenyl ether (nonaBDE)

For decaBDE and nonaBDE some uses are considered to be essential and are excepted from the decisions. These essential uses are listed below:

• Spare parts for aircraft that were manufactured prior to 1 January 2027 (until the end of the service life of the aircraft)

• Aircrafts (until 1 January 2027)

• Polyurethane foam for building insulation (until 1  January 2027)

• Electric and electronic equipment (until 1 January 2027)

• Spare parts for motor vehicles that were manufactured prior to 2019 (until 1 January 2036)

• Textile products (other than clothing and toys) that require anti‐flammable characteristics (until 1 January 2027).

The Industrial Chemicals Environmental Management Standard

IChEMS is a national approach in Australia that aims to efficiently manage the use, storage, handling and disposal of chemicals. By establishing standardised environmental protocols for the handling of industrial chemicals, IChEMS streamlines the process for industry to choose 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-based controls that should be applied to protect the environment. Industrial chemical uses that pose a greater risk to human health and the environment will be subject to more stringent controls.

IChEMS Register Schedules

In the IChEMS Register, Schedules 6 and 7 list the industrial chemicals of greatest environmental concern, e.g. chemicals that are persistent, bioaccumulative and toxic, such as POPs. All uses of chemicals in Schedules 6 and 7 are being phased out, except for essential uses. Schedules 2 to 5 list industrial chemicals of medium environmental concern. They are subject to controls that are proportionate to the nature and level of risk. Schedule 1 lists the industrial chemicals of lowest concern.

Previous consultations

In July 2023 the DCCEEW held consultations on the proposed scheduling decisions for perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorohexane sulfonate (PFHxS), and pentachlorobenzene (PeCB). Those consultations closed on 1 September 2023.

The Australian Government has issued an open invitation to the community to provide valuable input on a comprehensive set of proposed changes to the categorization of chemical introductions. These changes include the strengthening of reporting and record-keeping obligations under the Australian Industrial Chemicals Introduction Scheme (AICIS). Furthermore, the AICIS has carefully identified specific facets within the General Rules that require strengthening to ensure the safeguarding of human health and the environment, as well as to clarify of certain requirements. 

Within this consultation, the AICIS is highlighting several key proposals, including: 

1. Transitioning from written undertakings to a streamlined system of record-keeping and thereby simplifying compliance procedures. 

2. Enhancing the recognition and use of the International Nomenclature of Cosmetic Ingredients (INCI) names for both reporting and record-keeping purposes. 

3. Revise the categorization criteria to provide tangible advantages to various stakeholders, including soap manufacturers, chemical introducers involved in flavoring and fragrance blends, and those working with controlled hazardous chemicals. 

4. Extending the criteria and/or reporting requirements to strengthen measures to protect of both health and the environment. This includes measures aimed at preventing the inadvertent categorization of persistent organic pollutants (POPs) as exempted or unreported introductions. 

Manufacturers and importers have until November 9, 2023 to submit their views and comments on these proposals.  

Brazil's health regulatory agency, ANVISA recently announced a proposal to amend Resolution RDC 778/2023, which governs food additives and adjuvants in food technology. This proposed resolution seeks to establish a maximum tolerable residual limit for ethylene oxide in food additives, aiming to enhance consumer protection.

Ethylene Oxide Regulation

The proposed amendment to RDC 778/2023 introduces a crucial regulation concerning ethylene oxide levels in food additives. Specifically, it sets a maximum tolerable residual limit of 0.01 mg/kg for ethylene oxide in food additives. Ethylene oxide is a chemical used in various industrial processes, and its presence in food additives must be carefully controlled to ensure consumer safety.

Exceptions for Certain Food Additives

While the proposed regulation imposes strict limits on ethylene oxide, it includes exceptions for specific food additives. These exceptions apply to food additives that comply with the identity, purity, and composition specifications established by JECFA (Joint FAO/WHO Expert Committee on Food Additives) or FCC (Food Chemicals Codex). The listed food additives exempt from the maximum tolerable residual limit are as follows:

1. Polyoxyethylene (20) sorbitan monolaurate, polysorbate 20, INS 432
2. Polyoxyethylene (20) sorbitan monooleate, polysorbate 80, INS 433
3. Polyoxyethylene (20) sorbitan monopalmitate, polysorbate 40, INS 434
4. Polyoxyethylene (20) sorbitan monostearate, polysorbate 60, INS 435
5. Polyoxyethylene triestearate (20) sorbitan, polysorbate 65, INS 436
6. Grafted copolymer of polyvinyl alcohol (PVA) and polyethylene glycol (PEG), INS 1209
7. Polyethylene glycol, INS 1209

These additives, when meeting the specified criteria, will not be subject to the ethylene oxide limit, ensuring that they continue to be safe for consumption.

Public Consultation

ANVISA has initiated a public consultation period to gather feedback and comments from stakeholders and the general public. Interested parties are encouraged to submit their comments and suggestions regarding this proposed regulation within 45 days of the issuance of the public notice, which was posted on August 23, 2023. 

Ensuring Food Safety

The proposed regulation of ethylene oxide in food additives underscores ANVISA's dedication to ensuring the safety and quality of food products in Brazil. By setting a clear limit and providing exceptions for additives meeting stringent criteria, ANVISA aims to protect consumers from potential health risks associated with ethylene oxide exposure.

This important regulatory change reflects ANVISA's ongoing efforts to adapt and enhance food safety standards, aligning with international best practices while considering the unique needs of the Brazilian population. To submit your comments and engage in the public consultation process, visit ANVISA's official website.

Brazil has taken another big step in modernizing its chemical management regulations with the approval of the National Chemical Inventory Bill, PL 6120/2019. After years of rigorous evaluation and revisions in various committees, the bill has received the green light from the final Committee (CCJC) in the Chamber of Deputies, marking a crucial milestone in ensuring the safety and sustainability of the nation's chemical industry. 

The approval of this text, which incorporates all the revisions made during its journey through different committees, reflects Brazil's commitment to enhancing chemical safety and environmental protection. The bill now advances to the Senate for further consideration, bringing the country one step closer to implementing a comprehensive chemical management system. 

The PL 6120/2019, is a testament to the country's dedication to establishing a robust regulatory framework for the chemical sector. 

It is important to highlight the foundation it provides for prioritization and subsequent risk assessment, which already exists within the bill. Brazil's approach to these aspects demonstrates its commitment to proactively managing chemical risks. 

The bill also addresses the role of foreign manufacturers in the Brazilian market. It introduces the concept of the "Exclusive Representative" (Only Representatives in Europe). This provision allows Brazilian entities to act as representatives of foreign manufacturers, embracing all obligations within Brazil. Additionally, it grants Brazilian importers the ability to facilitate foreign manufacturers' direct entry of information into the future chemical registration system, speeding the process. 

The approval of the PL 6120/2019 is not just a significant achievement for Brazil's chemical industry; it has broader implications for the country's international standing. This development underscores the importance of aligning with international standards and regulations and reinforces Brazil's commitment to becoming a responsible global player. 

In conclusion, the approval of Brazil's National Chemical Inventory bill in the Commitee (CCJC) represents a pivotal moment in the country's journey toward modernizing its chemical management regulations.  

It not only positions Brazil as a leader in the region but also aligns the nation with international standards, fostering greater safety, sustainability, and transparency in the chemical industry.  

On August 21, 2023, the Ministry of Health of Vietnam issued a draft circular XX/2024/TT-BYT promulgating the National Technical Regulation on the Permissible Exposure Limits for 80 Chemicals in the Workplace (hereinafter referred to as the Regulation).

Content of the regulation 

The regulation defines a list of 80 chemicals and the corresponding occupational exposure limit (OEL) values ​​for the working environment (8-hour OELs and 15-minute OELs). The list can be accessed here.

The regulation also stipulates the methods to be used to determine the concentration limits of the respective substances. 

The regulation requires employers to assess the chemical substances present in the working environment at least once a year and implement the necessary measures to keep workers exposure to designated substances within the permitted limits. Workers must be provided with adequate occupational health and safety protection to reduce exposure to hazardous substances in the workplace. 

Timeline 

The regulation is now open for public consultation and comments can be made until October 16, 2023, and is expected to come into force in May 2024. 

On August 24, 2023, the Indonesian Food and Drug Supervisory Agency (BPOM; Badan Pengawas Obat Dan Makanan Republik Indonesia) published a new amendment on the technical requirements for cosmetics.  

The Indonesian government has issued regulations to protect the public from using cosmetic ingredients that do not meet safety, efficacy, and quality requirements. These regulations include Regulation Number 21 of 2020, Regulation Number 22 of 2020, and Regulation Number 24 of 2022. The regulations also require adjustments to ingredients permitted in cosmetics to reflect international technical requirements and scientific and technological advancements.  

In August 2023, the government decided to require a Decree from the head of the Food and Drug Supervisory Agency regarding changes in permitted ingredients in cosmetics. The draft was open for comments till 8 September 2023. 

Changes made in the updated version of cosmetics technical requirements 

The authority updated Companies with a Cosmetic notification number before the Head of this Agency's Decree came into force, ensuring they adhered to the provisions. 

ICONTEC, the Colombian standards organization is putting forth a proposal encompassing three technical standards pertaining to the realm of cosmetics. While these ICONTEC standards begin as voluntary guidelines, they could potentially become obligatory if they are incorporated by reference into a Colombian law or regulation. These three standards are presently open for public feedback on the ICONTEC platform until November 6, 2023. It is worth noting that these standards draw their foundation from pre-existing ISO counterparts:

NTC-ISO 11930:2018 - Assessing the antimicrobial protection of a cosmetic product.

NTC-ISO-TR 17276 - Employing an analytical approach for the screening and quantification methods of heavy metals in cosmetics.

NTC-ISO-21392 - Quantifying traces of heavy metals in finished cosmetic products utilizing the ICP/MS technique.

Peru's General Directorate of Environmental Health and Food Safety (DIGESA) has introduced a new set of regulations designed to establish authorization and labeling standards for paints and coatings containing lead. These regulations, which were officially unveiled in a notification to the World Trade Organization (WTO) on August 16, aim to implement a law enacted in 2021 that imposed restrictions on lead levels in such products.

Under the 2021 law (No. 31182), a maximum lead content limit of 90 ppm or 90 mg/kg by weight of the total content was imposed on products manufactured, imported, distributed, and marketed within the country. Interested stakeholders and the public have the opportunity to submit comments on these proposed regulations until October 15.

Key provisions within the proposed regulations include:

Sanitary Authorizations:

• Manufacturers, importers, and distributors of lead-containing paints and coatings would be obliged to secure sanitary authorizations from the National Health Authority before engaging in production or commercialization.
• The authorization application process would necessitate the submission of company information, details of the legal representative, product trade names, safety data sheets, and more.
• A power of attorney would also be required when the process is conducted by a proxy.
• Sanitary authorizations would be valid for five years, with new authorizations required in cases involving formula modifications.

Labelling Requirements:

• Lead-containing paints and coatings would need to incorporate specific information on their labels, including trade names, health authorization numbers, manufacturer information, details of the sanitary authorization holder, net content, lot numbers, production dates, preparation, dosage, application methods, instructions for use, storage conditions, and relevant pictograms, symbols, and danger phrases.
• Labeling information must adhere to the UN Globally Harmonized System (GHS) of classification and labeling of chemicals, which Peru adopted in May 2023.

Sanctions:

• The proposed regulations outline actions that would be considered violations and stipulate corresponding penalties, ranging from fines to the revocation of sanitary authorizations.
• A database of offenders would also be established, with information retained for a period of four years from the date of registration, after which the National Health Authority would take over data collection.

These regulations represent a vital step in aligning Peru with global standards in managing lead-based paints and coatings to ensure the safety and well-being of the public.

Ecuador has recently released a draft regulation for public scrutiny, outlining the procedures governing the issuance of toxicological evaluation reports, modifications to existing reports, and the alignment of labels with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for agricultural pesticides.

The proposed changes regarding GHS-compliant labeling have far-reaching implications, as they will affect all registered chemical-based agricultural pesticides in the country. According to the draft, applicants seeking approval for their products will be required to pay a stipulated fee and furnish the specified information for evaluation.

This draft regulation is currently open for public input and feedback, providing a crucial opportunity for stakeholders and concerned citizens to contribute their insights. The public comment period spans a duration of sixty days, commencing from August 30th. Your input during this period can play a significant role in shaping the final regulations governing toxicological evaluations and labeling practices for agricultural pesticides in Ecuador.

Link to the draft in Spanish: 23_12073_00_s.pdf (wto.org)

On 24 July 2023, Singapore’s National Environment Agency (NEA) announced that the listings for four substances (dechlorane plus, methoxychlor, UV-328, and terbufos) will be changed due to the decision at the 11^th meeting of the Conference of the Parties to the Rotterdam and Stockholm Conventions (COP11). Currently the four substances are regulated under the Hazardous Substances under the Environmental Protection and Management Act (EPMA) and the Environmental Protection and Management (Hazardous Substances) Regulations

COP11 meeting

At the 11^th meeting of the Conference of the Parties to the Rotterdam and Stockholm Conventions (COP11) in May 2023 it was decided to add dechlorane plus, methoxychlor and UV-328 to Annex A of the Stockholm Convention on Persistent Organic Pollutants (POPs).  Annex A lists the chemicals for which Parties must take action to eliminate their production and use. Details about the three substances can be found here.

It was furthermore decided to list Terbufos in Annex III of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. Annex III lists the chemicals that are subject to the prior informed consent (PIC) procedure. Terbufos is a soil insecticide used commonly on sorghum, maize, beet and potatoes and is known to pose a high to extremely high risk to aquatic organisms, birds, and small mammals due to its toxicity.

Timeline

22 October 2023: From this date the import and export of Terbufos will be subject to the PIC procedure of the Rotterdam Convention. This means that prior approval must be obtained from the Chemical Control and Management Department (CCMD) for every export of the chemical. Furthermore, the CCMD must be notified at least one month prior to the expected date of export.

12 May 2024: The manufacture, import, and export of dechlorane plus, methoxychlor, and UVA-328 as well as products containing these chemicals will not be allowed in Singapore. Companies with existing stock of the chemicals and/or their products imported before this date are allowed to deplete their stocks locally.

On the 4th of September 2023, the United Nations Environment Programme (UNEP) released what is known as the “Zero Draft” of the forthcoming Global Plastics Treaty.  The draft was prepared by the Peruvian government in its role as Chair of the Iintergovernmental Negotiating Committee (INC) for the treaty with the support of the INC Secretariat. It is based on a wide range of ideas from nations on the treaty's contents. 

The Zero Draft will serve as the starting point for negotiations at the next conference of the International Negotiating Committee (INC-3), which will be held in Nairobi, Kenya, in November 2023. By the end of 2024, a formal treaty should be in place. 

Main objectives of the Zero Draft 

The main objectives of the Zero Draft are as follows: 

• To end plastic pollution, including in the marine environment, and to protect human health and the environment. 

• The prevention, progressive reduction, and elimination of plastic pollution throughout the life cycle of plastic by 2040.  

• The management of both the use of plastics and plastic waste, while contributing to the achievement of sustainable development. 

The manufacturing of basic plastic polymers, including their raw materials and precursors, may have adverse effects on human health or the environment. Parties should take the appropriate precautions to prevent and mitigate these effects. Parties shall take the necessary steps to reduce and, where appropriate, eliminate the use of chemicals, groups of chemicals, and polymers in plastic polymers, plastics, and plastic products6 that have the potential to cause adverse effects on human health or the environment at any stage of the life cycle of plastics or that have properties that could make their safe and environmentally sound management difficult, such as their reusability. 

Key steps to achieve the Zero Draft objectives 

According to the draft below points must be followed to achieve the goal:  

1. Emissions and releases of plastic throughout its life cycle  

Each Party is responsible for preventing and eliminating the emissions and releases of plastic polymers, plastics, including microplastics, and plastic goods to the environment from those sources. The following emissions and releases should be covered by this clause:  

• Emissions of hHazardous substances, including microplastics.  

• Releases to soil and water from production, transportation, and use of chemicals and polymers of concern. 

• Releases of chemicals and polymers of concern, plastics and plastic products, including microplastics, to air, soil, and water, as well as ecosystems.

2. Existing plastic pollution, including in the marine environment 

In order to increase awareness and stop future plastic pollution, particularly littering in freshwater and coastal regions, each Party shall make information on common forms of plastic pollution, practises, and behaviours that contribute to plastic pollution publicly available. 

The parties must work together to evaluate, identify, and prioritise the accumulation zones, hotspots, and sectors: 

• that are most affected by current plastic pollution, including in the marine environment. 

• where quantities and types of litter pose a threat to species or habitats, taking into account the full life cycle of plastics.

Finance 

Each Party shall take steps to reduce financial flows from all domestic and foreign, public and private sources, towards projects that result in emissions and releases to the environment from plastics and plastic products throughout their life cycle, including microplastics, and to increase financial flows from all domestic and foreign, public and private sources, towards projects that prevent or reduce emissions and releases of plastics to the environment. 

Federal strategies  

In order to execute the commitments under the draft and to accomplish its objective(s), each Party shall create and implement a national plan. The national plans must at the very least contain pertinent information relating to: Primary plastic polymers; chemicals and polymers of concern; problematic and preventable plastic products; product design and performance; reduce, reuse, refill, and repair of plastics and plastic products; use of recycled plastic contents; extended producer responsibility; emissions and releases of plastic through its life cycle; waste management; fishing gear; current plastic pollution, including in the marine environment; and just transition. 

You can read full draft here: https://wedocs.unep.org/bitstream/handle/20.500.11822/43239/ZERODRAFT.pdf 

On 20 September, the Ministry of Environmental Protection and Natural Resources of Ukraine notified the draft Technical Regulation on the Safety of Chemical Products to the World Trade Organisation (WTO). This notification signals Ukraine's commitment to aligning its regulatory framework with international practices.

This draft regulation draws inspiration from and seeks to incorporate most of the provisions found in Regulation (EC) No 1907/2006 of the European Parliament and of the Council of December 2006, concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH). By doing so, Ukraine aims to harmonize its standards with those of the European Union.

Stakeholders and interested parties now have a 60-day window, starting from the date of notification, to provide their input on this proposed regulation, contributing to the shaping of Ukraine's chemical safety landscape.

Content of the technical regulation

The regulations introduced outline the procedures for:

• Government registration of chemical substances before they are placed on the market, requiring companies to assess the intrinsic hazardous properties of substances through testing and to carry out chemical safety assessments (10 tonnes/year and above) using a risk-based approach.

• Data sharing to avoid unnecessary testing by companies in the course of government registration of substances, which should be common only for identical substances.

• In-depth evaluation of chemicals by authorised central executive authorities.

• Provision of safety information by suppliers in the form of safety data sheets (including exposure scenarios where developed) down the supply chain.

• Identification of particularly hazardous substances in line with the EU's Substances of Very High Concern (SVHCs) and Toxic Substances (Acute Toxic and Specific Target Organ Toxicity (STOT)) and compilation of relevant lists.

• Imposing restrictions on the manufacture, placing on the market and use of certain chemical products that pose an uncontrolled risk to human health and/or the environment.

Purpose of the technical regulation

The purpose of the draft Technical Regulation is to implement the framework provisions of the Ukrainian Law on Ensuring Chemical Safety, Security and Management of Chemical Products, which entered into force on 29 December 2022 and will be applicable from 29 June 2024. 

It aims to ensure a high level of protection of human health and the environment, the free movement of chemical products on the internal market, the promotion of the use of alternative methods for assessing the hazards of chemical products and the promotion of innovation while increasing competitiveness, and to define the basic requirements for ensuring chemical safety in the manufacture, placing on the market and use of chemical products by economic operators.

Timeline

The date of adoption of the technical regulation has not yet been set. It will enter into force 3 months after its publication.