GPC Newsletter Jan-2024

In a significant move to protect public health, the U.S. Environmental Protection Agency (EPA) issued orders on December 1, 2023, directing Inhance Technologies LLC (Inhance) to cease the production of per- and polyfluoroalkyl substances (PFAS). These chemicals, which are integral to the manufacture of fluorinated high-density polyethylene (HDPE) plastic containers, have been identified as posing health risks by leaching into various consumer, industrial, and agricultural products.

PFAS

Known for their persistence in the environment and in the human body, PFAS accumulate over time, contributing to long-term health risks even at low exposure levels. Studies, including those by the Centers for Disease Control, reveal that nearly all individuals tested already have traces of PFAS in their blood. The substances can enter the human body through drinking water, consumption of contaminated fish, and exposure to PFAS-contaminated groundwater.

HISTORY

The Environmental Protection Agency (EPA) is intensifying efforts to address per- and polyfluoroalkyl substance (PFAS) contamination following a series of incidents. In 2019, Easton, Massachusetts, struggled with perfluorooctanoic acid (PFOA) contamination in its drinking water, which was traced back to a mosquitocide. EPA investigations revealed that the PFAS in the mosquitocide originated from fluorinated high-density polyethylene (HDPE) plastic containers manufactured by Inhance. These containers, when fluorinated, release various PFAS, including PFOA, which can migrate into liquid products like pesticides.

The regulatory process gained momentum in March 2022 when EPA issued a Notice of Violation to Inhance, for failing to disclose its PFAS manufacturing activities. With a single company historically producing up to 200 million containers annually, EPA recognized the substantial risk to drinking water supplies. Legal action ensued forcing the company to submit, albeit belatedly, significant new use notices (SNUNs) for the nine PFAS it produces.

The release of just 2.2 Kg of the nine PFAS could contaminate vast quantities of water, surpassing the proposed maximum contaminant level of 4 parts per trillion for PFOA in drinking water. Consequently EPA, under the Toxic Substances Control Act (TSCA), is prohibiting the continued manufacture of three highly toxic PFAS—PFOA, perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA)— which are produced during the fluorination of HDPE. For the remaining six PFAS (PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA, and PFODA), EPA mandates Inhance to cease production and conduct additional testing before potential restart, acknowledging the inherent risks to health and the environment.

WAY FORWARD

Starting February 28, 2024, EPA's recent orders emphasize its commitment to addressing PFAS-related risks. The regulatory action not only signals EPA's dedication to mitigating the risks of PFAS exposure but also highlights the Agency's commitment to protecting public health and the environment from the harmful effects of persistent chemical contaminants. Importantly, alternative processes to the current fluorination method offer industries the opportunity to meet product packaging standards without compromising public safety.

In a significant development on December 14, 2023, the U.S. Environmental Protection Agency (EPA) released its draft risk evaluation for Tris(2-chloroethyl) phosphate (TCEP), a flame retardant widely used in paints, coatings, textiles, and aerospace applications. This is a crucial step under the Toxic Substances Control Act (TSCA) and opens the door for public comment.

Unprecedented Findings: Unreasonable Risks to Health and Environment

EPA's draft risk evaluation, based on the latest scientific evidence, has preliminarily found that TCEP poses unreasonable risks to both human health and the environment. This finding comes as the first among the 20 High-Priority Substances prioritized in 2019. EPA's improved risk evaluation process includes a thorough assessment of potential exposure risks to sensitive subpopulations such as workers, children, and subsistence fishers.

TCEP Background: A Chemical with Lingering Threats

TCEP, which has a long history of use in various industries, has been linked to serious health effects, including kidney cancer, reproductive issues, neurological disorders, developmental challenges, and kidney-related effects. Despite a substantial reduction in U.S. production since 2014, TCEP still finds application in certain paints, coatings, and aerospace products. Importantly, its non-chemical binding to materials allows it to leach into the environment, raising concerns about water, sediment, soil, and air contamination.

Worker Risks and Consumer Exposure

For workers, the EPA assessment identified unreasonable risks from both inhalation and dermal exposure, even without assuming universal and proper use of Personal Protective Equipment (PPE). Consumer exposure, particularly through inhalation and ingestion, reveals risks associated with TCEP leaching from textiles and products into indoor air. Children may be at increased risk if they are frequently exposed to TCEP-containing materials.

Environmental Impact: Fish, Water, and Subsistence Fishers at Risk

The presence of TCEPs in water can lead to its accumulation in fish, posing unreasonable risks to those who consume them. Subsistence fishers and tribal populations, who rely heavily on fish for food and cultural practices, face elevated risk. EPA's evaluation also includes environmental impact on aquatic organisms chronically exposed to TCEP through surface water and sediment.

Call for Action: Public Comment and Peer Review

EPA's draft risk evaluation is now open for public comment until January 5, 2024. Interested parties can participate via the docket EPA-HQ-OPPT-2023-0265 on www.regulations.gov. Additionally, a virtual preparatory meeting on March 5, 2024, will precede the letter peer review by independent scientific experts that will start on March 13, 2024. The Agency encourages the submission of specific exposure information to help refine the risk estimates for the final evaluation.

Next Steps

Should EPA conclude in the final risk evaluation that TCEP poses unreasonable risks, the Agency is committed to taking swift action. This includes the development of risk mitigation options to safeguard both human health and the environment.

On 7 December 2023, the European Commission proposed a package of three legislative proposals to reform chemical assessments to make the process faster, simpler and more transparent. The ‘one substance one assessment’ package aims to streamline the assessments of chemicals across EU legislation, strengthen the knowledge base on chemicals, and ensure early detection and action on emerging chemical risks.

The package involves reallocating tasks between four EU agencies to ensure coherent and transparent assessments of chemicals used in a wide range of products, including medical devices, toys, food, pesticides, and biocides.

Key points of the legislative proposals

The three legislative proposals are part of the Commission’s Chemicals Strategy for Sustainability (CSS) and aim to achieve better prevention through improved chemicals data management. The key points are:

Establishment of a Common Data Platform: The platform will provide access to all data compiled under EU legislation and held by the EU agencies and the Commission. The Common Data Platform will integrate existing platforms such as the Information Platform on Chemical Monitoring (IPCHEM), the Public Activities Coordination Tool (PACT), and the EU Chemicals Legislation Finder (EUCLEF). It will include data on hazards, physico-chemical properties, environmental occurrence, emissions, uses, environmental sustainability of chemicals, and ongoing regulatory processes.

Redistributing tasks and improving of cooperation between EU agencies: To avoid the inefficient use of resources and unnecessary costs of having multiple committees carrying out similar assessments, the aim is to strengthen cooperation and consolidate scientific and technical work on chemicals in the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Environment Agency (EEA), and the European Medicines Agency (EMA). The agencies will be better equipped to coordinate priorities, timelines, processes, and methodologies used for the assessment of chemicals. Moreover, knowledge gained from assessments under one piece of legislation (e.g. biocides) can be re-used for another one (e.g. toys).

Human biomonitoring data collection: A systematic collection of human biomonitoring data (e.g. from blood or breast milk) generated in the EU will be used to estimate the level of exposure of EU citizens to chemicals.

Establishment of a monitoring and outlook framework: Such a framework will allow early detection of chemical risks, such as PFAS, to prevent contamination from becoming widespread. It will facilitate a rapid regulatory response and track the impact of regulatory measures implemented on chemicals. The framework will include an early warning and action system, and a set of indicators,

Enable the European Chemicals Agency (ECHA) to generate data as needed.

Ensure transparency of scientific studies on chemicals, including those commissioned by companies.

The full text of the three proposed regulations can be accessed here, here, and here.

Next steps

The three proposals will now be discussed by the European Parliament and the Council under the ordinary legislative procedure.

On 5 December 2023, the European Parliament and the Council reached a provisional agreement on the revision of the Regulation on the Classification, Labelling and Packaging of Chemicals (CLP). The new measures will improve the protection of consumers, workers and the environment, while improving the functioning of the EU market for products containing hazardous chemicals. The revised regulation will improve communication on hazardous chemicals including for chemicals sold online. It will also speed up the identification of hazardous chemicals and mixtures at EU level.

CLP Regulation

The CLP Regulation is the basis for the EU legislation on the risk management of chemicals. It implements the United Nation’s Globally Harmonised System (GHS) for the classification and labelling of chemicals in the EU. Manufacturers and importers are required to classify, label and package their hazardous chemicals in accordance with the CLP Regulation before placing them on the market.

The legislative proposal to revise the CLP Regulation was presented by the European Commission on 19 December 2022. As part of the revision package, the European Commission adopted a Delegated Act adding definitions and criteria for the classification of substances and mixtures with the following properties into established hazard classes:

• Endocrine disrupting

• Persistent, bioaccumulative and toxic

• Very persistent and very bioaccumulative

• Persistent, mobile and toxic

• Very persistent and very mobile

This Delegated Act entered into force on 20 April 2023.

Content of the revision

The key changes introduced by the revision of the CLP Regulation are as follows:

• Clearer labelling of hazardous chemicals: The revision introduces advertising requirements and a minimum font size for labels on hazardous chemicals. The requirements also apply to online sales.

• Digital labelling: Companies will have the option of using fold-out labels and digital labelling. Important information and hazard pictograms must still be displayed on the packaging.

• Online purchases: Websites will have to display the hazardous properties of the products leading to better protection for consumers when buying hazardous chemicals online.

• Complex substances: The rules for classifying complex substances (known as ‘more than one constituent substances’ (MOCS)) have been updated. A specific derogation was agreed upon for plant extracts including essential oils.

• Classification proposals: The Commission will also have the right to develop classification proposals for potentially hazardous substances in addition to Member States and the industry. This will speed up the identification of hazardous substances.

• Refillable chemicals: To support the safe sale of household chemicals in bulk the first rules on refillable chemicals will come into force. The use of refillable chemicals will reduce packaging and therefore packaging waste.

• Poison centres will receive better and faster information for medical emergencies.

Once adopted these changes, together with the new hazard criteria for endocrine disrupters, persistent and toxic chemicals that came into force in April 2023, will ensure better communication and identification of chemical hazards.

Next steps

The new Regulation will now have to be formally adopted by the European Parliament and the Council. Once formally adopted, it will enter into force 20 days after its publication in the Official Journal of the EU.

On 4 December 2023, the European Commission published a draft delegated regulation aimed at revising a number of provisions concerning perfluorooctane sulfonic acid (PFOS) and its derivatives under Regulation (EU) 2019/1021 on persistent organic pollutants, commonly referred to as the POPs Regulation.

PFOS under the POPs Regulation

PFOS and its derivatives are listed in Annex I of the POPs Regulation. The Annex I listing includes Unintentional Trace Contaminant (UTC) limits in substances, mixtures and articles.

PFOS was the first per- and polyfluoroalkyl compound (PFAS) to be regulated in the EU, and the UTC values were set a long time ago. It is therefore considered unlikely that PFOS is still present in substances and mixtures at the current UTC level of 10 mg/kg.

As regards the UTC for articles, the uses of PFOS (e.g textiles and leather coating, use in semiconductors, etc.) are very similar to those of perfluorooctanoic acid (PFOA), another PFAS regulated under the POPs Regulation. There is no evidence that a different limit value than for PFOA is needed.

Modifications in the draft regulation for PFOS

For the reasons described above the following modifications for PFOS should be made:

• Align the wording of the substance identification for the entry of PFOS with that for PFOA (i.e. change ‘PFOS and its derivatives’ to ‘PFOS, its salts and PFOS-related compounds’).

• Introduction of a UTC level for PFOS and its salts of 0,025 mg/kg (in line with the one for PFOA)

• Reducing the UTC for PFOS-related substances in substances, mixtures, and articles to 1 mg/kg (in line with the one for PFOA)

• Delete of point 5 (availability of analytical methods).

• Delete a specific exemption for the use of PFOS as a mist suppressant for non-decorative hard chromium plating.

Timeline

The public consultation on the draft regulation is open until 1 January 2024. Feedback can be give here. The European Commission plans to adopt the Regulation in the first quarter of 2024.

On 16 November 2023, an amendment to the Persistent Organic Pollutant (POPs) Regulation came into force in Great Britain (England, Scotland, and Wales). The amendment adds perfluorohexane sulfonic acid (PFHxS), its salts, and PFHxS-related compounds to the list (Part A of Annex 1) of substances whose production, placing on the market and use are prohibited under the POPs Regulation.

PFHxS substances

PFHxS substances belong to the group of compounds collectively known as per- and polyfluoroalkyl substances (PFAS). They are used as surfactants in a wide range of industrial and commercial products such as food packaging, stain and water-resistant materials, fire-fighting foams, and paint additives. PFHxS, its salts, and PFHxS-related compounds were added to Annex A of the Stockholm Convention at COP-10 in June 2022 without any specific exemption. Each Party to the Convention is required to prohibit the chemicals listed in Annex A and/or to take the necessary legal and administrative measures to eliminate their production, use, import and export. The substances were banned in the EU in August 2023.

PFHxS, its salts, and PFHxS-related compounds are defined is as follows:

1. Perfluorohexane sulfonic acid (CAS No. 355-46-4, PFHxS), including branched isomers.

2. Its salts.

3. Any substance that contains the chemical moiety C₆F₁₃SO₂- as one of its structural elements and that potentially degrades to PFHxS.

PFHxS substances are highly resistant to chemical, thermal and biological degradation due to their strong carbon-fluorine bonds. This resistance to degradation makes them persistent in the environment. Numerous studies have documented elevated levels of PFHxS in soil, water and a variety of ecosystems. Human exposure to PFHxS occurs mainly through ingestion of food and drinking water but also in indoor environments through dust or from consumer products containing PFHxS or its precursors.

Amendment to POPs Regulation

The Persistent Organic Pollutants (Amendment) (No. 2) Regulations 2023 (Statutory Instrument 2023 No. 1217) amend Part A of Annex 1 to Regulation (EU) 2019/1021 of the European Parliament and of the Council on persistent organic pollutants by adding PFHxS, its salts, and PFHxS-related compounds.

The amendment specifies the following concentration limits up to which the newly listed substance may be present as an unintentional trace contaminant:

1. Where the sum of the concentrations of PFHxS and any of its salts present in a substance, mixture or article is equal to or below 0.025 mg/kg (0.0000025% by weight).

2. Where the sum of the concentrations of any PFHxS-related compounds present in a substance, mixture or article is equal to or below 1 mg/kg (0.0001% by weight).

3. Where the sum of the concentrations of PFHxS, any of its salts, and any PFHxS-related compounds present in concentrated fire-fighting foam mixtures that are to be used or are used in the production of other fire-fighting foam mixtures is equal to or below 0.1 mg/kg (0.00001% by weight).

A full impact assessment has not been carried out for this instrument, as it is expected to have minimal or insignificant effects on the private, voluntary, or public sectors. Instead, a de minimis assessment has been carried out, recognising that this instrument may impose some costs on businesses. However, the overall estimated net impact is expected to be less than £5 million per year.

KKDIK, also known as Turkey REACH, was enacted on June 23, 2017, as part of the EU Adaptation policy. This regulation focuses on the registration, evaluation, authorization, and restriction of chemicals to ensure the protection of human health and the environment.

Registration for KKDIK began on January 1, 2021, and the deadline for registration was set on December 31, 2023. However, on 23 December 2023, the Ministry of Environment, Urbanization and Climate Change of Türkiye announced an official postponement of the KKDIK deadline. The main objective of this announcement for KKDIK is to determine different deadlines for tonnage bands like how the UK is experiencing with UK REACH. 

Key points from this announcement:

• A new paragraph was added to Article 12 (joint submission of data by multiple registrants) giving responsibilities to TOBB (Union of Chambers & Commodity Exchange) regarding the election of lead registrants, data and cost-sharing, joint registration process by future procedures and principles to be published by the Ministry.

• Amends the beginning date in Article 24 (inquiry) and deadline in 25 (SIEF formation) of the regulation, extending them from "31/12/2023" to "31/12/2030."

• Extends the termination date of SIEFs to 31/12/2032 from 31/12/2025.

• Deadline for pre-registration to be removed and amended in a way that references timelines specified in procedures and principles to be published by the Ministry

• New transitional article for new separate deadlines

  • Substances above 1000 tons, substances above 100TPA that are Aquatic Acute 1 or Aquatic Chronic 1 (H400,H410), and substances above 1TPA that are CMR category 1A or 1B having the registration deadline of 31/12/2026

  • Substances above 100TPA have a deadline of registration by 31/12/2028

  • Substances above 1TPA have a deadline of registration by 31/12/2030

• Evaluation, inclusion in the authorization list, and creation of candidate substances list for authorization to begin by 31/12/2026

At GPC, we are always ready to act on your behalf for your compliance needs with our worldwide team of experts and professionals to ensure the safety of your trade in Türkiye.

Stay tuned for our webinar on the update, explaining each change in more detail and how it will affect the registration process.

The Bureau of Indian Standards (BIS) is seeking comments on a revised standard for plastic emulsion paints until January 10, 2024. The revised standard will tighten restrictions on lead content and introduce limits for Volatile Organic Compounds (VOCs). 

First Standard for Plastic Emulsion Paints 

Two parts of this standard were previously issued i.e. IS 5411 ‘Plastic emulsion paint: Part 1, For interior use’ and IS 5411 ‘Plastic emulsion paint: Part 2 For exterior use’. These two parts are now included in this revised standard. 

The previous standard also included various types of finishes to bring it into line with the practices that existed at the time. Therefore, the drying time requirements for both the finish and the hard dry were adjusted according to the type of finish. Additional optional requirements such as spreading capacity and hiding power as well as spreading time were removed. Gloss value at 60° was also included for various classes. 

First Revision 

The first revision of this standard was initiated with the aim of incorporating the lead limit into the standard. It was recognised that the product, which is widely used for interior and exterior surface decoration of building, may not be feasible to manufacture with a low lead restriction. The committee therefore set a lead limit of 300 ppm for a product used in building finishes. This limit aims to prevent dangerous exposure to lead and its long-term health effects. 

Second Revision 

The second revision aims to limit volatile organic compounds (VOCs) in paint products, focusing on their negative impact on human health and the environment. The limits will be set taking into account the capabilities of small, medium, and large manufacturers to produce compliant products. The ultimate goal is to eliminate VOCs by promoting advanced technologies and processes. 

Furthermore, the limit for lead has been reduced from 300 ppm in the first revision to 90 ppm. The lead content is calculated as metallic lead including the content of lead, lead compounds, or mixtures of both.    

Following surface preparation and priming, the second revision of the standard specifies the conditions and procedures for sampling and testing plastic emulsion paint, which is used for both interior and external building surface protection and decoration.  

Further conditions and requirements can be found here. 

On 19 December 2023, the Central Government of India, after consultation with the Bureau of Indian Standards (BIS), published a Gazette Notification regarding the Quality Control Order (QCO) for Toluene. According to the notification the QCO will be called the Toluene (Quality Control) Second Amendment Order, 2023 and it will come into force on 22 December 2024,  

The Principal Order for Toluene was published in the Gazette of India on 24 December 2021 and was subsequently amended four times.

The Chinese Supervision and Management Measures of Toothpaste Products has been enforced since 2023.12.1. To facilitate the enforcement of the Measures, NMPA published and enforced the Management Rules for Toothpaste Registration. This Management Rules will guide applicants with relevant registration requirements and procedures.

There are three chapters and three annexes in this Rules. Chapter one gives general information on toothpaste registration. Chapter two illustrates the required documents, the applicants and agent’s conditions, renewal of information and certain timelines for registration. In chapter three, detailed materials requirements for dossier preparation are explained. According to it, the following information must be prepared: 

1. Name, address, and contact information of the filing person.
2. Name, address, and contact information of the production enterprise.
3. Product name information. 
4. Product formula.
5. Product execution standards.
6. Product label sample. 
7. Product inspection report.
8. Product safety assessment information. 

The three annexes are Standard Preparation Instructions for Toothpaste Product Implementation, Toothpaste Product Implementation Standards (sample) and Requirements for Microbiological and Physical and Chemical Inspection Items for Toothpaste Registration.

The Management Rules will be enforced the same time as the Supervision and Management Measures of Toothpaste Products on 1st Dec. 2023. For more information, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com.

On November 30, 2023, the South Korean Ministry of Food and Drug Safety (MFDS) issued a partial amendment to the Regulations on Cosmetics Safety Standards, etc., including the addition of some ingredients of hair dye to the list of raw materials that cannot be used in cosmetics and the addition of the chemical substance identification number (CAS No.) to improve the convenience of identifying raw materials that cannot be used in cosmetics. 

The main content of the revision is as follows. 

• Added seven hair dye ingredients such as 2-amino-4-nitrophenol to the raw materials that cannot be used in cosmetics and lowering the concentration limit when two hair dye ingredients such as hydrochloric acid 2,4-diaminophenol are used in cosmetics. 

• Added the Chemical Identification Number (CAS No.) and the chemical name of raw materials that cannot be used as cosmetics ingredients and raw materials whose use need to be restricted. 

• "Methoxypropylaminocyclohexenylidene ethoxyethylcyanoacetate," which has been reviewed as a sunscreen, is added in accordance with the Regulations on Designation of Cosmetic Raw Materials and Review of Changes (notified by the Food and Drug Administration). 

On 29 November 2023, the Thai Ministry of Public Health issued a Draft Notification outlining the registration, issuance, and renewal procedures for hazardous substances. The focus of this initiative is to streamline and improve the registration process through the implementation of an online submission system under the jurisdiction of the Food and Drug Administration (FDA).

Key Points of the Draft Notification:

Electronic Submission Requirement:

Business operators dealing with Type 2 and Type 3 hazardous substances will be required to submit applications and relevant documents through the FDA’s designated electronic system.

The application categories include registration of hazardous substances, permission to manufacture or import samples (for quantities exceeding 5 kilograms or 5 litres), self-certification for smaller quantities, amendment/change of registration information, and renewal of the registration certificate.

In cases where submission through the FDA's electronic system is not feasible, alternative procedures are allowed. These should be submitted to the FDA or to other designated agencies/locations/procedures as specified by the FDA.

Validity of Certificate:

The certificate of registration is valid until the end of the sixth calendar year from the year of issuance. However, officials may specify a different period of validity if necessary.

Change of Registration Details:

Changes to registration details will be noted on the permit or issued in writing. In some cases, a new certificate of registration may be issued.

The primary objective of this initiative is to improve the efficiency of the hazardous substance registration process by introducing an online submission system. This move is in line with global trends in regulatory practices and is expected to simplify procedures for businesses and ensure better compliance with safety standards.

Timeline:

The proposed date of adoption is yet to be determined, and the date of entry into force is set for the day following its publication in the Government Gazette. As per Thailand’s notification to World Trade Organization (WTO), stakeholders and interested parties have a 60-day window from the date of notification to provide their comments on the proposed draft.

Relevant documents:

The Hazardous Substances Act B.E. 2535 (1992)

Notification of the Ministry of Public Health regarding registration, issuance and renewal of the registration certificate of hazardous substances under the responsibility of the Food and Drug Administration B.E. 2552 (2009)

Notification of the Ministry of Public Health regarding registration, issuance and renewal of the registration certificate of hazardous substances under the responsibility of the Food and Drug Administration (No. 2) B.E. 2558 (2015)

Notification of the Ministry of Public Health regarding registration, issuance and renewal of the registration certificate of hazardous substances under the responsibility of the Food and Drug Administration (No. 3) B.E. 2561 (2018)

In a significant step to address environmental concerns, the Japanese Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MoE) have jointly issued a consultation, calling for the designation of methoxychlor, dechlorane plus, and UV-328 as Class I Specified Chemical Substances under the Chemical Substance Control Law (CSCL). The consultation was released on 12 December 2023.

Global Context

This announcement follows the Eleventh Meeting of the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants, held in Geneva, Switzerland, from 1 May to 12 May 2023. During the conference, these three substances, methoxychlor, dechlorane plus, and UV-328, were added to Annex A of the Convention. The Stockholm Convention is a global treaty that aims to protect human health and the environment from chemicals that are persistent, geographically widespread, bioaccumulative, and harmful to human health or the environment.

Proactive Measures and Restrictions

As a party to the Stockholm Convention, Japan is now ready to take proactive measures to control and eliminate these Persistent Organic Pollutants (POPs). The plan is to prohibit the manufacture and import of methoxychlor, dechlorane plus, and UV-328, starting from the third quarter of 2024, with no plans to establish "essential use" exemptions. This means that the use of these substances in the production of other products will also be strictly prohibited.

Furthermore, Japan will implement import bans on specific products containing dechlorane plus and UV-328, to restrict their entry into the market. The affected product categories include flame retardant additives for resins, silicone rubber, lubricants, adhesives and tapes, as well as components, housings, wires, and cables of electrical and electronic products for dechlorane plus. For UV-328, the import bans will apply to paints and varnishes, lubricants, adhesives, tapes, sealants, and its use as a UV absorber in plastics.

Health and Environmental Effects of the Targeted Chemicals

Dechlorane Plus is a chlorinated flame retardant that is commonly used in electronics and automobiles. Human exposure to Dechlorane Plus has been linked to neurodevelopmental and reproductive disorders. UV-238 is an ultraviolet stabilizer that protects polymers from degradation. It has been associated with adverse liver and kidney effects in animals. Methoxychlor is an organophosphate pesticide that is banned in the United States and the European Union due to its toxicity to aquatic life, persistence, ability to bioaccumulate, and endocrine-disrupting activity.

The public is invited to comment on the proposed measures until 10 January 2024.

In a significant development for the food industry, the Brazilian regulatory landscape witnessed a noteworthy update with the publication of Normative Instruction - IN No. 267 on December 12, 2023. This latest instruction, which amends its predecessor, IN No. 211 from March 1, 2023, introduces crucial modifications to the regulations governing food additives and technology coadjutants.

Understanding the Changes

The amendments outlined in IN No. 267 encompass a spectrum of aspects, ranging from technological functions to maximum limits and conditions for the use of food additives and coadjutants. As the industry grapples with evolving consumer preferences, health considerations, and technological advancements, staying abreast of these regulatory changes is imperative for businesses to thrive.

Implications for Businesses

For companies operating in the food sector, compliance with these regulatory adjustments is not only a legal requirement but also a strategic imperative. Non-compliance could lead to serious consequences, including legal repercussions and damage to a brand's reputation.

In November 2023, the Environmental Management Bureau of the Department of Environment and Natural Resources (DENR-EMB) released the 2022 and 2023 lists of chemicals and chemical substances to be included in the Philippine Inventory of Chemicals and Chemical Substances (PICCS).

All compounds that are currently used, imported, distributed, processed, manufactured, stored, exported, treated, or transported in the Philippines are included in the Philippine Inventory of Chemicals and Chemical Substances (PICCS). The first PICCS was published by the DENR-EMB in 1995 and has been regularly updated since then.

Companies that import and manufacture chemicals that are listed in the PICCS are not required to notify and secure  clearance from the DENR-EMB before manufacturing or importing these chemicals.  

Current update of the PICCS

The list for 2022 contains 96 compounds and 2023 list contains 66. With the addition of these 162 compounds, there are a total of 22,439 compounds in the PICCS.

Peru has issued a Supreme Decree (DS 031-2023-SA) that complements the Decree 1570 for management of Chemical Substances, introducing comprehensive regulations for hazardous substances used in household, industrial, and public health applications. The decree adopts the Globally Harmonized System (GHS) for classification and labeling, covering products such as industrial chemicals, disinfectants, pesticides, and hazardous substances under the Rotterdam Convention.

The Regulation applies to both individuals and companies involved in activities related to the import, manufacturing, formulation, elaboration, distribution, commercialization, storage, use, handling, and disposal of hazardous substances designated for domestic, industrial, and/or public health applications as classified in the new Decree.

The new Decree encompasses the following finished products:

• Chemical Products for Industrial Use
• Disinfectants for inert surfaces in domestic, industrial, and/or public health settings, including disinfectant products for water in swimming pools.
• Pesticide products for domestic, industrial, and/or public health use.
• Hazardous products falling under the Rotterdam Convention.

The initial exemption section specifies that the new rules do not extend to:

a) Pharmaceutical products, including narcotic drugs, medicines for human use, and psychotropic substances.

b) Food additives.

c) Hydrocarbons and their derivatives.

d) Disinfection products for medical devices.

e) Products for agricultural and veterinary use.

f) Chemical inputs and controlled products.

g) Radioactive chemical substances.

h) Chemical substances susceptible to use in chemical weapons as per national laws.

i) Methyl and ethyl alcohol regulated by local laws on methyl alcohol.

The new Decree signifies the adoption of GHS for the classification, labeling, and Safety Data Sheets (SDS) for the covered substances.

The new Decree also outlines detailed requirements and processes for authorization, renewal, and modification of authorization for various product categories, including:

• Sanitary Authorization for chemical products for industrial use.
• Sanitary Authorization for disinfectants intended for commerce in domestic, industrial, and/or public health applications.
• Sanitary Authorization for pesticides intended for commerce in domestic, industrial, and/or public health applications.
• Sanitary Authorization for the importation of disinfectants or pesticides for industrial use and/or public health not intended for commerce.
• Sanitary Authorization for the importation of hazardous products within the framework of the Rotterdam Convention. 

Effective Date The new Regulation will come into effect within six months of its publication date, which is December 2, 2023.

Mexico has recently released a crucial compilation known as the "List of Frequently Transported Hazardous Substances and Materials" slated to entirely replace the previous 2011 version within the next 60 days, by February 16, 2024.

This new iteration of the Official Mexican Standard (NOM) serves as a comprehensive guide for identifying hazardous goods during transportation. It includes information such as their class, hazard division, secondary hazard, UN-assigned numbers, specific provisions governing their transportation, quantitative limits for limited and excepted quantities, and detailed instructions for packaging usage.

The scope of this NOM extends to shippers, carriers, and consignees involved in the transportation of hazardous goods via land, air, or sea. It encompasses various types of containers and packaging, including packages, large packages, intermediate bulk containers, large containers and packaging, portable tanks, multi-element gas containers, and bulk containers, each subject to their own set of special provisions outlined in the standard.

The National Environment Agency (NEA) of Singapore is seeking feedback on proposed regulations regarding formaldehyde content in paints. The aim is to restrict the availability (both in retail stores and online) of formaldehyde-containing paints that are intended for indoor use. The consultation closes on 13 December 2023.

Formaldehyde (CAS No. 50-00-0)) is widely used in the manufacture of resins, as a disinfectant, or as a preservative in building materials. It is added to paints to inhibit bacterial and fungal growth. Exposure to formaldehyde can cause adverse health effects.

The following controls have been proposed by NEA:

• Only indoor paints without added formaldehyde will be allowed to be sold in Singapore (the measured formaldehyde content must be less than 0.01 % w/w).

• A Hazardous Substance (HS) licence will be required for companies manufacturing and/or importing indoor paints with added formaldehyde for export or re-export purposes.

• Labelling requirements will be imposed on industrial paints and outdoor paints containing formaldehyde.

The proposed controls are expected to take effect from 1 July 2025 to allow industry time to prepare.

The Environmental Protection Authority (EPA) of New Zealand has announced it is seeking feedback on aquatic risk assessments and proposed hazard classifications for eight synthetic pyrethroids (SPs) as part of its ongoing reassessment of hazardous substances. Synthetic pyrethroids, which are widely used in a variety of sectors including agriculture, forestry, public health, and domestic use, are the focus of this critical assessment. 

The eight synthetic pyrethroids under review are: 

1. Alpha-cypermethrin 

2. Cypermethrin 

3. Deltamethrin 

4. Permethrin 

5. Tetramethrin 

6. Bifenthrin 

7. Lambda-cyhalothrin 

EPA emphasizes the importance of reassessing these SPs for which there is evidence of use in New Zealand. This initiative provides an opportunity for stakeholders and interested parties to provide their insights related to hazard classification endpoints and aquatic risk assessment for these substances. 

EPA has already established hazard classification endpoints for human health and environmental safety for these eight SPs. They have also carried out an aquatic risk assessment for six SPs that are widely used in commercial agriculture and horticulture. 

In particular, EPA has identified significant risks to the aquatic environment from spray drift due to the high aquatic toxicity associated with these synthetic pyrethroids. These risks are not considered to be manageable with conventional risk mitigation measures and further information is needed to improve the aquatic risk assessment. 

EPA is specifically seeking feedback on the following aspects: 

1. The endpoint values selected for hazard classification. 

2. Higher order refinements for the aquatic risk assessment. 

3. Identification and detailed description of critical uses within the industry. 

4. Proposals for new or additional risk reduction measures to manage risks associated with critical uses. 

Interested parties and stakeholders are invited to submit their feedback, with a deadline set at 5:00 pm on February 29, 2024. 

This call for feedback represents a crucial step in ensuring the safety and sustainability of synthetic pyrethroid use in New Zealand, as EPA actively engages with the public and industry experts to refine its assessments and mitigate potential risks. Your input could play a significant role in shaping the future regulations for these essential chemicals.