GPC Newsletter Feb-2024

On December 18, 2023, the U.S. Food and Drug Administration (FDA) released the final guidance for the industry regarding cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The guidance supports stakeholders in submitting cosmetic product facility registrations and product listings to the FDA. It outlines submission responsibilities, necessary information, submission procedures, timelines, and specific exemptions from registration and listing requirements.

Portal

The guidance provides details about a newly launched electronic registration and listing portal called Cosmetics Direct. This portal is now accessible. Additionally, the FDA is in the process of creating paper forms, Form FDA 5066 and Form FDA 5067, to serve as alternative tools for submitting cosmetic product registration and listing information. These forms are expected to be available soon on the Registration & Listing of Cosmetic Product Facilities and Products platform.

The FDA will use the FDA Establishment Identifier (FEI) as the mandatory facility registration number. To streamline the registration process, facility owners or operators are required to obtain an FEI number before submitting their facility registration. To check for an existing FEI number, please use the FEI Search Portal.

It is important for the responsible person to obtain the relevant FEI number(s) for each facility where their cosmetic products are manufactured or processed, as these facility registration number(s) are necessary for product listing submissions. In the case of a small business that is exempt from registration and does not have a facility registration number, the product listing can be submitted using the facility name and address.

Exemptions

MoCRA provides exemptions from facility registration and product listing for specific small businesses.

However, these exemptions do not apply to facilities or responsible persons associated with the manufacture or processing of certain cosmetic products, including the following:

• Products that regularly come into contact with the mucus membranes of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that, under customary or usual conditions of use, are intended to change the appearance for more than 24 hours and removal by the consumer is not part of such conditions of use. 

Delayed Enforcement 

The FDA will not enforce the cosmetic product facility registration and product listing requirements for an additional six months after the December 29, 2023 deadline, until July 1, 2024. During this period, regulated industries will have more time to meet these obligations.

Additionally, the FDA will not enforce the registration requirement for facilities that begin cosmetic product manufacturing or processing after December 29, 2022, and the listing requirement for products first marketed after that date until July 1, 2024.

On January 8, 2024, the U.S. Environmental Protection Agency (EPA) finalized a Significant New Use Rule (SNUR) that prevents companies from resuming or initiating the production or processing of 329 per- and poly-fluoroalkyl substances (PFAS) that have been inactive for years without a comprehensive EPA review. These "inactive PFAS" were previously used in various industries without proper assessment and pose potential environmental risks. The rule aligns with the Biden-Harris Administration's three-year commitment to environmental justice, public health protection, and addressing the impacts of these persistent "forever chemicals" under the PFAS Strategic Roadmap.

History

When the Toxic Substances Control Act (TSCA) was enacted in 1976, it grandfathered in thousands of chemicals, allowing them to remain in commerce without additional EPA review. For the first 40 years, only about 20% of new chemicals underwent formal EPA review, and the Agency lacked the authority to address chemicals without sufficient information. This gap led to the introduction of PFASs into commerce without comprehensive reviews.

The 2016 TSCA amendments, part of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, mandate a formal safety review for all new chemicals before they enter commerce. The new Significant New Use Rule (SNUR) requires EPA to conduct thorough reviews before inactive PFASs can be reused. TSCA also mandates EPA to maintain and publish the TSCA Inventory, which designates each chemical as "active" or "inactive" in commerce. An "inactive" status indicates that a chemical has not been manufactured (including imported) or processed in the U.S. since June 21, 2006.

The current regulation applies to all PFAS labeled as "inactive" on the TSCA Inventory and not under a SNUR, adhering to the reporting criteria outlined in the Active-Inactive rule for these specified chemicals.

Process

Companies wishing to use any of the 329 chemicals must notify EPA beforehand. EPA will then conduct a thorough review of health and safety data to assess potential risks to human health or the environment, following the guidelines of the updated 2016 law. Any necessary restrictions will be imposed before the new use can commence. The evaluation of new PFAS and their uses falls under EPA's framework, which was introduced in June 2023.

On 23 January 2024, the European Chemicals Agency (ECHA) announced that 5 chemicals have been added to the Candidate List of Substances of Very High Concern (SVHC) due to their hazardous properties. This means that the Candidate List now contains 240 entries. In addition, the existing list entry for dibutyl phthalate has been updated by ECHA to include its endocrine disrupting properties to the environment.

Substances of Very High Concern

Substances of Very High Concern (SVHCs) are substances that may cause serious and often irreversible effects on human health and the environment. A substance identified as an SVHC will be added to the Candidate List for possible inclusion in the Authorisation List. Some of the entries in the Candidate list are groups of chemicals, so the total 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 an authorisation for continued use.

Legal obligations for substances in the Candidate List

Under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation there are legal obligations for substances included in the Candidate List.

• Suppliers must inform their customers and consumers if their articles contain more than 0.1 % (weight by weight) of a Candidate List substance.

• Consumers have the right to ask suppliers whether their products contain SVHCs.

• Suppliers of Candidate List substances, either on their own or in mixtures, must provide a safety data sheet (SDS)to their customers.

• Importers and manufacturers of articles containing a substance from the Candidate List must notify ECHA within six months from the date the substance has been added to the List.

In addition, under the Waste Framework Directive, companies must notify ECHA if the articles they produce contain SVHCs in concentrations above 0.1 % (weight by weight). This notification is then made publicly available in ECHA's Substances of Concern in Products (SCIP) database.

New substances in the Candidate List

The uses of the five new Candidate List entries include inks and toners, adhesives and sealants as well as washing and cleaning products. The substances are persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or toxic for reproduction. The new entries (and the updated entry) added on 23 January 2024 are listed below.

On 5 January 2024, the European Commission took a significant step to improve the regulatory landscape by adopting a Delegated Regulation (2024/197) for an adaptation to technical progress within Regulation (EC) 1272/2008. This regulation, commonly known as the CLP Regulation, deals specifically with the classification, labelling, and packaging of substances and mixtures. The regulation came into force on 25 January 2024.

The main objective of the Delegated Regulation is to make important updates to Table 3 of Part 3 of Annex VI to the CLP Regulation, which contains the list of harmonised classification and labelling (CLH) of hazardous substances. The proposed changes include the introduction of 28 new entries and the revision of 24 existing entries. The complete list is available here. The scientific assessment of these substances has been carried out in collaboration between the European Chemicals Agency (ECHA), its Committee for Risk Assessment (RAC) and the Member States authorities for decision-making at the Commission.

This proposed updates demonstrates the European Commission's commitment to keeping abreast of scientific and technical progress. The updates will play a crucial role in streamlining the harmonised classification and labelling processes and promoting consistency across the European Union. Manufacturers, importers, and downstream users are urged to stay informed about these proposed changes, as the new classifications will apply from 1 September 2025.

Harmonised classification and labelling

Manufacturers, importers, or downstream users are required to (self-)classify and label hazardous substances and mixtures in order to ensure a high level of protection for human health and the environment.

For substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) and respiratory sensitisers classification and labelling should be harmonised across the EU to guarantee appropriate risk management. This is achieved through harmonised classification and labelling (CLH).

The harmonised classifications are listed in Annex VI to the Classification, Labelling and Packaging of Chemical Substances and Mixtures (CLP) Regulation. All manufacturers, importers, and downstream users of such substances should apply the harmonised classifications.

Proposals for CLH can be made for substances not currently listed in Annex VI to CLP. For substances with an existing harmonised classification changes may be made due to new information, scientific or technical developments, changes in classification criteria or re-evaluation of existing data.

On 30 January 2024, the European Chemicals Agency (ECHA) launched its latest feature, ECHA CHEM, a user-friendly platform for sharing information on chemicals. The first release, which can be accessed here, includes data from all REACH registrations and aims to provide accessible information to the public.

ECHA is known for maintaining the largest chemicals database in the EU, combining data submitted by industry with regulatory information. ECHA CHEM is designed to make the growing amount of information hosted by the Agency more accessible.

First release and future plans

The first version of ECHA CHEM contains information from over 100,000 REACH registrations submitted by companies to ECHA. Plans are in place to expand the database later this year to include the redesigned Classification and Labelling Inventory, followed by the launch of the first set of regulatory lists.

Previous chemical platforms

ECHA's previous Information on Chemicals platform, launched in 2016, grew rapidly and now contains information on more than 360,000 chemicals. In 2022, ECHA announced the development of a new system for publishing data on chemicals, with ECHA CHEM reflecting the Agency's commitment to efficiently manage the growing amount of data while embracing technological advances.

Insights from ECHA

Commenting on the significance of the launch, Mercedes Viñas, ECHA’s Director of Submissions and Interaction, stated, "ECHA CHEM is a significant step forward in enhancing our service for sharing data on chemicals gathered through ECHA’s current activities. It makes the information available online within a stable system and in a user-friendly manner."

Kai Taka-aho, Director of Information Systems, highlighted the flexibility of the platform, saying, "ECHA CHEM has been designed to be a flexible technical platform capable of handling large amounts of data, and adjustable for different needs. With the technological choices made, ECHA CHEM is a future-proof solution".

On 11 January 2024, the UK Health and Safety Executive (HSE) announced that it is proposing to update the status of the list entries for 90 substances on the Great Britain Mandatory Classification and Labelling (GB MCL) list. These substances were included in the GB MCL list when the UK left the European Union.

Background on the 90 substances

The EU Harmonised Classification and Labelling (EU CLH) entries from the 14^th and 15^th Adaptation to Technical Progress (ATP) for the 90 substances were adopted in 2017 and 2018. They were subsequently included in the GB MCL list but were not retained in GB law following the UK's exit from the EU and the end of the transition period on 31 December 2020. At the time the HSE believed that the entries would be retained in full in Great Britain (England, Scotland and Wales), but this was not the case. The HSE has now decided to use the Article 37 and Article 37A procedures as a corrective measure to address this issue.

Proposed changes

The HSE has now published a consolidated Agency Opinion and is formally proposing mandatory classification and labelling for the 90 substances based on the scientific and technical assessment of the scientific data, in accordance with Article 37 and Article 37A of the GB Classification, Labelling and Packaging (GB CLP) Regulations. This initiative is supported by a consolidated Technical Report and Agency Opinion, both of which are now publicly available in the HSE GB CLP publication table.

The 90 substances are divided into 3 groups:

• For the 62 substances listed in Table 1 of the consolidated Agency Opinion, the Agency Opinion does not differ from the opinion of the EU Committee for Risk Assessment (RAC). Therefore no further consideration under Article 37A is required.

• For the 26 substances listed in Table 2, the Agency Opinion differs from the consolidated Agency Technical Report. However, the HSE has not received any new scientific or technical information that would change the proposed GB MCLs in Table 2 and therefore no further assessment under Article 37A is required for these substances.

• For the last two substances (titanium dioxide and granulated copper) listed in Table 3, the HSE is aware of information that may change the classification for these two substances. Therefore, these substances will be further assessed under the Article 37A procedure, and no GB MCL is proposed for these substances at this time.

Next steps

The HSE will make a recommendation to Ministers for a Ministerial Decision, with consent of the devolved Governments (Scotland and Wales), to legally enforce the proposed GB MCLs for these 90 substances. The expected compliance dates will be in line with their publication in the HSE’s GB CLP publication table, which is set for April 2024.

In the meantime, duty holders are reminded that no immediate action is required. The HSE had previously advised compliance with the harmonised classification and labelling of these substances as set out in the guidelines in the 14^th and 15^th ATPs.

The classification and labelling of most substances will not change following this update. However, specific substances such as titanium dioxide in powder form and granulated copper will require further assessment under the Article 37A procedure.

On 23 January 2023, the UK Health and Safety Executive (HSE) issued a reminder to all companies involved in the export and import of Prior Informed Consent (PIC) chemicals. Companies are required to submit detailed reports of their activities in 2023 by 31 March 2024. This annual reporting is a legal requirement under Article 10 of the GB PIC Regulation.

Detailed reporting required

Companies must provide the HSE with the exact quantities, measured in kilograms, of PIC chemicals they have either exported from or imported into Great Britain (England, Scotland, and Wales) during the previous year. The HSE has made templates available on its website to facilitate this process and  ensure that companies can efficiently comply with the reporting requirements.

This annual report must also include the movement of PIC chemicals to or from Northern Ireland (NI). When reporting exports and imports within the European Union, companies are not required to specify the EU country involved. However, reporting the movement of these chemicals to or from Northern Ireland will be useful for record-keeping purposes.

Exemptions from reporting

It is important to note that not all PIC chemical transactions are subject to this reporting requirement. Exemptions include:

• Special reference identification number (RIN) requests for exports for research and analysis purposes in quantities not exceeding 10 kg per year to each importing country.

• Imports for research and analysis purposes in quantities not exceeding 10 kg per year from any country.

For mixtures and articles, companies are only required to report the quantity of the PIC chemical contained in the mixtures and articles.

NIL returns

In cases where a company has not exported a particular PIC-listed chemical in 2023, despite having submitted an export notification for it, it must submit a NIL return to confirm this.

Submission guidelines

Completed templates should be sent to ukdna@hse.gov.uk no later than the 31 March 2024. The subject line of the email should include the text "GB PIC - Annual Reporting - Article 10 - 2023 - [company name]" to ensure the correct categorisation of the submission.

Publication of data

Later in the year, the HSE plans to publish the aggregated and anonymised data on its website, providing an insight into the trends and volumes of PIC chemical trade in 2023.

The Revolving Fund Directorate of the Ministry of Environment, Urbanization, and Climate Change has disclosed the registration fees for KKDIK in 2024. Compared to 2023, the fees have increased by an average of 44% and a maximum of 60% in TL.

Currently, registration fees range from 180 TL/€6 (for SME companies jointly registering 1-10 tonnage) to 43,000 TL/€1315 (for large companies individually registering 1000+ tonnage substances). The fees vary based on the tonnage band, company size, and whether it is a joint or individual submission. This underscores the importance of companies opting for joint registration.

If you haven't completed the pre-registration of your substances, please do so to be part of the Substance Information Exchange Forum (SIEF) and to engage in joint registration.

For more details on the 2024 KKDIK registration fees and updated deadlines under KKDIK, please contact GPC.

On 6 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 the five polymer products listed in the table below. 

Timeline: 

It shall come into force on the expiry of one hundred and eighty days from the date of its publication in the Official Gazette. 

The Bureau of Indian Standards (BIS) published the revised draft of Specification for Petroleum Jelly for the Cosmetic Industry (Second Revision of IS 4887) in December 2023.

Petroleum jelly, a soft, semi-solid substance produced from petroleum oils, is used to make creams, lipsticks, lubricating creams, hair dressings, foundation creams, and emollients for chapped skin.

Specification for Petroleum Jelly for the Cosmetic Industry

The Indian Standard (Specification for Petroleum Jelly for the Cosmetic Industry), first published in 1968, underwent its first revision in 1980. This second revision includes an increase in the melting range (the upper limit has been increased from 56°C to 80°C), a new requirement for mercury, and alternative test methods for the determination of arsenic. Cross-referred standards and the marking clause have also been updated.

Amendments in the second revised IS 4887

Table of requirements for petroleum jelly for the cosmetics industry

Containers must be labelled with the following information (requirement 5-8 are new compared to the first revision of the standard):

1. Name of the material

2. Name of the manufacturer and his registered/recognized trademark, if any

3. Net mass of the material

4. Month and year of manufacturing/packing

5. Batch number in a manner to enable traceability including its date of manufacture

6. Use before or expiry date as per statutory requirements

7. List of ingredients as per statutory requirements

8. Any other information required by statutory authorities

Deadline for comments

The Bureau of Indian Standards (BIS) is consulting on the new standard for petroleum jelly used in cosmetic products until March 12, 2024.

On 12^th January 2024, the China Oral Care Products Industry Association (COCIA) has published a first national inventory of toothpaste ingredients. 

This inventory collected 1026 toothpaste ingredients. And the information of the Chinese name, INCI name and maximum historical usage levels have been given. This inventory was codified from COCIA’s members in 2020 and 2022. But they haven’t organized a systemic safety evaluation of the ingredients listed. 

Though it is just an association version, toothpaste manufacturers can still take this inventory as a reference when filing products under CSAR regulation which classified toothpaste as ordinary cosmetic form 1 December 2023. 

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

On January 9, 2024, the National Assembly of South Korea passed five laws related to the environment, including the “Chemical Substances Registration and Evaluation Act” and the “Chemical Substances Control Act.” The purpose of these laws is to improve the rational management of chemicals based on their harmfulness by changing the registration criteria for new chemicals to meet international standards and reorganizing the current system for classifying toxic substances.  

The Ministry of Environment (MoE) said that the amendment to the Chemical Substances Registration and Evaluation Act, which currently requires new chemicals to be registered if they are produced or imported in quantities of more than 100 kg per year, will relax the registration requirement to 1 tonne per year. This is in response to the industry’s request to adjust the domestic criterion to the same as the EU or Japan.  

The amendment to the Chemical Substances Registration and Evaluation Act also added provisions for the disclosure of information on substances that are reported at less than 1 tonne per year and for the government to review their suitability. It also imposed a duty on business operators to ensure the safety of chemical substances by requiring that substances lacking hazard information be presumed to be harmful until their harmlessness is verified. At present, hazardous chemicals are defined as “toxic substances” and regulated uniformly, and substances that cause harm to humans through short-term exposure are classified as “acutely hazardous substances to the human body,” substances that cause harm to humans through repeated exposure or long-term accumulation are classified as “chronically hazardous substances to the human body,” and substances that cause harm to aquatic life are categorized as “ecologically hazardous substances.” 

The amendment to the Chemical Substances Control Act stipulated that permitted, restricted, and prohibited substances should be excluded from the definition of hazardous chemicals and that those used in very small quantities or with a low probability of accidents should be exempted from inspection and diagnosis. It also stipulated that if the handling of chemicals is very small or the risk is low, it should be changed from “authorization" to "notification.” The Ministry of Environment said that the revised bill was drafted after discussions at the Chemical Safety Policy Forum, which included various stakeholders such as civil society organizations and industry. 

Japan's Ministry of Health, Labour and Welfare (MHLW) has taken a significant step towards improving transparency and accessibility by releasing an English version of its positive list of substances assessed for safety in food contact materials (FCMs). The information made available on 25 December 2023, aims to provide clarity on permitted substances and additives used in food packaging.

Components of the published material

The English publication of the list is structured into three parts:

1. Table 1 - Polymers: This list categorizes polymers into five categories and explains the characteristics (i.e. glass transition temperature and melting point) of the five categories.
2. Table 2 – Additives: A comprehensive list of 827 additives. For each additive, the table includes its substance names in Japanese and English, CAS numbers, use limits according to polymer group, and associated requirements.
3. Essential Monomers: A detailed list comprising 21 Annexes for different types of essential monomers, their CAS numbers and requirements.

Additional resources and upcoming publications

In an effort to further assist stakeholders and the public, the MHLW is set to publish a list of frequently asked questions (FAQs) on its official website. These FAQs are intended to provide additional clarification on the requirements associated with the Positive List.

The Japanese version of the Positive List was initially published on 30 November 2023. However, in recognition of the global significance and the diverse audiences affected by these regulations, the English version is intended to facilitate a broader understanding and compliance.

Enforcement and legal amendments

Enforcement of the Positive List is scheduled to commence on 1 June 2025. This follows the MHLW’s earlier publication in April 2020 of the first draft positive list of substances assessed for safety in contact with utensils, containers, and packaging. The amendments to Article 18(3) of the Food Sanitation Act came into effect on 1 June 2020.

The Australian Department of Climate Change, Energy, the Environment and Water (DCCEEW) has recently published scheduling decisions under the Industrial Chemicals Environmental Management Standard (IChEMS) for a number of persistent organic pollutants (POPs).

The Industrial Chemicals Environmental Management Standard                                                                                                                                       

IChEMS is a national approach in Australia designed to efficiently manage the use, storage, handling and disposal of chemicals. It not only facilitates industry compliance by standardising environmental protocols for industrial chemicals but also encourages the adoption of less hazardous alternatives. Under IChEMS, chemicals are listed on the IChEMS Register, which categorises chemicals into seven schedules based on their environmental risk and provides essential information on appropriate risk-based controls to protect the environment. More hazardous chemicals, particularly those that pose a threat to human health, are 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.

Scheduling decisions

 In the second half of 2023 the DCCEEW held three consultations on the proposed scheduling decisions for perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorohexane sulfonate (PFHxS), pentachlorobenzene (PeCB), brominated flame retardants (BFRs) and short-chained chlorinated paraffins.

These consultations, which received 100 submissions, have resulted in the following substances being added to the IChEMS Register. From 1 July 2024 (1 July 2025 for PFOA, PFOS and PFHxS), the import, manufacture, use, and export of these substances will be prohibited in Australia.

Substances added to Schedule 6:

• Decabromodiphenyl ether and nonabromodiphenyl ether (decaBDE and nonaBDE)

Substances added to Schedule 7:

• Perfluorooctanoic acid (PFOA) and related substances

• Perfluorooctanesulfonic acid (PFOS) and related substances

• Perfluorohexanesulfonic acid (PFHxS) and related substances

• Pentachlorobenzene (PeCB)

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

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

• Hexabromocyclododecane (HBCDD)

• Short chain chlorinated paraffins (SCCPs)

These chemicals are globally recognised as persistent organic pollutants (POPs) that pose a significant environmental risk and require effective management to protect the environment. Inclusion of these chemicals in the IChEMS Register will establish a consistent standard for their management across Australia, contributing to a safer circular economy.

On 16 January 2024, the National Pharmacy Regulatory Division in Malaysia released the cosmetic notification on ‘Guidelines for Control of Cosmetic Products in Malaysia’ (Circular No. 1/2024). The amendments are made to Annex II, III, IV, VI, and VII of the ASEAN Cosmetic Directive (ACD). The ASEAN Cosmetic Committee agreed to make some amendments to the ACD back in November 2023.

The amendments are as follows

Key points:

The authority has reminded the cosmetic notification holders to comply with all regulations as mentioned in Regulation 18A of the Drug and Cosmetic Control Regulations 1984 to avoid any difficulties.

Chile's chemical industry is launching its Chemical Registration System under the Decree 57. This development aims to enhance chemical safety and regulatory oversight in the country. As the registration database opens its doors, industries dealing with industrial hazardous substances face a crucial window for compliance – from February 9 to August 30, 2024.

Understanding the Registration Requirement

The registration requirement applies to covered substances manufactured in or imported into Chile in quantities exceeding 1 ton per year. The initial reporting period spans 2022 and 2023, setting the stage for a thorough assessment of chemical products within this timeframe.

Local Manufacturers and Importers 

The Instruction Guide underscores the distinction between local manufacturers and local importers, providing clear guidance on the registration process for each category. It is crucial to note that foreign manufacturers are exempt from the registration obligation, and Chile does not have an Only Representative structure in place.

Defining Hazardous Substances

The Instruction Guide provides more definition of industrial hazardous substances that must be registered during the initial deadline. This clarification ensures a comprehensive understanding of the substances that fall under the regulatory ambit.

Chile's Chemical Registration System is a landmark initiative in bolstering chemical safety and regulatory compliance. As the registration period for industrial hazardous substances commences, stakeholders are urged to engage proactively. The Instruction Guide serves as a crucial document ensuring a smooth transition towards a safer and more compliant chemical landscape in Chile. 

On 11 December 2023, five East African countries (Burundi, Kenya, Rwanda, Tanzania, and Uganda) notified the World Trade Organization (WTO) of Draft East African Standards for 10 fertilisers. The notifications are open for comments for 60 days from the date of notification.

East African Standards

East African Standards (EAS) are developed by the East African Standards Committee (EASC) to harmonise quality requirements for products and services in the East African Community. The aim is to remove trade barriers within the Community through harmonised standardisation.

East African Standards are developed by technical committees that are representative of key stakeholders including government, academia, consumer groups, the private sector, and other interested parties. East African Standards are subject to review, to keep pace with technological advances. Users of the East African Standards are therefore expected to ensure that they always have the latest versions of the standards they are implementing.

Included fertilisers

The draft East African Standards for the 10 fertilisers and biofertilisers are listed in the table below. The purpose of the standards is to protect human and animal health and safety and protection of the environment; to reduce trade barriers; to reduce costs and increase productivity; to prevent deceptive practices and to protect consumers.

Content of the draft standards

The draft standards contain information on the following:

• General requirements (form and particle size)

• Specific requirements (content and test methods)

• Contaminants (limits and test methods for heavy metals)

• Packaging  

• Labelling (in accordance with ISO 7409 in English and/or any other official language of the country of destination).

• Sampling

The National Environment Agency (NEA) of Singapore launched a public consultation on 18 January 2024. The consultation seeks public input on the proposed regulation of medium-chain chlorinated paraffins (MCCPs), long-chain perfluorocarboxylic acids (LC-PFCAs) and nine mercury-added products under the Environmental Protection and Management Act (EPMA) and the Environmental Protection and Management (Hazardous Substances) Regulations (EPM(HS) Regulations). The consultation closes on 15 February 2024.

Aim of the consultation

As a signatory to the Stockholm and Minamata Conventions, Singapore is committed to reducing the use of persistent organic pollutants (POPs) and mercury emissions. As the competent authority, NEA ensures compliance with these international agreements.

NEA's primary objective with the proposed controls is to regulate two groups of chemicals and nine mercury-added products by classifying them as hazardous substances. This is in line with international obligations under the Stockholm and Minamata Conventions, which aim to reduce the environmental and health risks posed by these substances.

Two groups of chemicals proposed for control

NEA has identified two groups of chemicals to be regulated:

• Medium-chain chlorinated paraffins (MCCPs): Chlorinated paraffins with carbon chain lengths in the range C14-C17 and chlorination level equal to or exceeding 45 % chlorine by weight. MCCPs are considered to be persistent and may be long-range transported in the environment.

• Long-chain perfluorocarboxylic acids (LC-PFCAs): Perfluorocarboxylic acids with chain lengths in the range C9-C21, their salts and related compounds. LC-PFCAs are characterised by their persistence and bioaccumulation in the environment. Moreover, long-chain PFCAs, their salts and related compounds may be long-range transported in the environment.

MCCPs and LC-PFCAs are expected to be added to Annex A of the Stockholm Convention at the 12th Conference of the Parties (COP12) to be held in 2025. NEA plans to introduce strict controls on the import, export, and use of these chemicals, allowing current operations under specific licences until a ban by the Stockholm Convention is adopted in 2025.

Proposed controls on mercury-added products

NEA also focuses on nine specific mercury-added products to be phased out by the end of 2024. These products, which include certain types of lamps, measuring devices, and electronic components, are recognised as being harmful to the environmental because they can release mercury.

The list includes the following products:

• Compact fluorescent lamps with an integrated ballast (CFL.i) for general lighting purposes that are ≤ 30 watts with a mercury content not exceeding 5 mg per lamp burner 

• Cold cathode fluorescent lamps and external electrode fluorescent lamps of all lengths for electronic displays

• Mercury vacuum pumps

• Tyre balancers and wheel weights

• Photographic film and paper

• Propellant for satellites and spacecraft 

The full list of products is available here. The ban on their manufacture, import, and export will take effect from 1 January 2025.

Call for public participation

Feedback to the consultation can be submitted via NEA’s online form here or by sending an email to Primus_ONG@nea.gov.sg and Nikki_LEE@nea.gov.sg by 15 February 2024.  NEA looking for clear, concise, and constructive comments. Respondents are encouraged to identify their affiliations and provide substantiated suggestions or data to enrich the consultation process. 

The Pakistan Environmental Protection Agency has recently published the draft Handling, Manufacture, Storage, Import of Hazardous Waste and Hazardous Substances Rules, 2024, in short the Hazardous Substances Rules, 2024. The draft rules are open for comments until 31 January 2024.

Substances included

Schedule I of the draft contains a list of the names and CAS numbers of 242 substances/substance groups that are considered as hazardous substances under the Hazardous Substance Rules, 2024.

The list includes persistent organic pollutants (POPs) listed under the Stockholm Convention, e.g. industrial chemicals such as polychlorinated biphenyls (PCBs) and pentachlorobenzene (PeCB), as well as pesticides such as aldrin, chlordane, and DDT. It also contains heavy metals such as mercury, cadmium and lead and their compounds.

Application for a licence

To apply for a licence to manufacture, import, transport, handle, store or dispose of  a hazardous substance, Form A of Schedule II of the draft rules must be submitted to the Pakistan Environmental Protection Agency along with an Environmental Impact Assessment (EIA) of the project, an approved building plan of the premises, a list of machinery and equipment installed, and a list of qualified personnel and the number of workers employed. Upon approval of an application a fee of 100,000 Pakistani rupees (approximately US$ 350) must be paid. The licence is valid for 3 years from the date of issue and is renewable.

Import Licence: To obtain a license to import hazardous substances into Pakistan, in addition to the information required in Form A, the applicant must provide details which include the port of entry, details of the transport from the exporting country to Pakistan, the quantity of the hazardous substance, the safety precautions to be taken and the intended use of the substance. An Environmental Impact Assessment (EIA) may also be required, depending on the intended use of the substance.

Hazardous substance Transport Licence: To obtain a licence for the transport of hazardous substances, the application must include, in addition to the information contained in Form A, details such as the names and addresses of the sender and recipient, the quantity of the substance, the mode of transport with details of the vehicle, the route from origin to destination, and the scheduled date and time of the transport.

Licence conditions

Packaging: Containers for hazardous substances must be suitably sized, constructed, and designed to prevent leakage during storage, transport, and use to ensure the safety of these processes. In addition, the design should prevent the hazardous substance from deteriorating in a way that would increase the likelihood of causing adverse environmental effects, either directly or in combination with other substances.

Labelling: The label must be legible and indelible and contain standard information about the substance and the licence holder. In addition, it must contain a warning statement consisting of the word DANGER! in red on a contrasting background, an image of a skull and crossbones and instructions for use, storage and handling.

Premises: The conditions for the premises in which a hazardous substance is manufactured, handled, stored or disposed of are specified in Schedule IV of the draft. In addition, the outdoor or gate of the premises must be fitted with a notice with the words DANGER! HAZARDOUS SUBSTANCE! in red on a contrasting background and a prominent image of a skull and crossbones.

Safety precautions: The licence holder must communicate specific safety precautions to individuals receiving hazardous substances, including reading and following container instructions, using protective clothing when opening containers, avoiding contact with skin or eyes, and refraining from eating, drinking, or smoking near hazardous substances. In addition, for workers handling hazardous substances, the licence holder must ensure age-appropriate employment, provide thorough safety training, and provide protective clothing and equipment. Other measures include the provision of water for personal and equipment washing, regular cleaning of protective equipment, regular medical check-ups for workers, and maintaining adequate fire-fighting and emergency equipment, along with a first-aid facilities on the premises.

Records: The licence holder is required to keep a detailed record of the quantity, type, quality and origin of the hazardous substance and the names and addresses of the persons to whom the hazardous substance is sold or supplied.