GPC Newsletter Jan-2022



Regulatory News

To ensure that the Environmental Protection Agency (EPA) has the best tools for protecting human health and the environment under Toxic Substances Control Act (TSCA), the agency released a draft TSCA systematic review protocol on the 20th of December 2021.

This protocol is also aimed at strengthening EPA’s approach to review and select the scientific studies used for informing TSCA chemical risk evaluations. This is also to support the Biden-Harris Administration’s commitment of making evidence-based decisions and developing policies guided by the best available scientific data.

The protocol is produced to meet the criteria of ‘comprehensive, workable, objective, and transparent’ which the previous systematic review process failed to meet. The February 2021 report from the National Academies of Sciences, Engineering, and Medicine (NASEM) TSCA Committee said it was an incomplete and difficult to follow documentation. The revision of the approach and update of TSCA systematic review process by EPA led to the new draft.

The new draft includes key recommendations and approaches for the current TSCA risk evaluation of 20 high priority chemicals and will undergo a peer review at Scientific Advisory Committee on Chemicals (SACC) meeting on April 19 to 22, 2022. The draft also enables the use of recent and future IRIS systematic reviews. Furthermore, it includes new methods aimed at reducing bias and improving evaluation consistency for all chemicals.

Further details specific to how the protocol has been used for each of these chemical risk evaluations are available on EPA’s website. From now till February 18, 2022, the agency is accepting comments on the draft protocol for 60 days.

 

 

Last Update: 2022-01-04

A study and ingredients’ comparison done for 20 perfumes in Belgium, Denmark, and the Netherlands revealed that these perfumes contain substances of concern that have been listed by authoritative bodies. The study shows the presence of 26 problematic substances in 20 perfumes, and they can be categorised into the following groups:

  • Suspected Endocrine Disrupting Chemicals (EDCs)
  • Reprotoxic Substances
  • Allergens
  • Substances that are harmful to the environment

The dangerous substances and their functions include:

Substances Functions
Alpha-isomethyl ionone Fragrance
Amyl Cinnamal Fragrance
Benzyl alcohol fragrance, solvent
Benzyl benzoate fragrance, solvent
Benzyl cinnamate fragrance
Benzyl salicylate fragrance
BHT antioxidant
Butylphenyl methylpropional fragrance
Cinnamyl alcohol fragrance
Citral fragrance
Citronellol fragrance
Citrus aurantium amara flower water fragrance, skin conditioning
Coumarin fragrance
Disodium EDTA stabilising
Ethylhexyl methoxycinnamate UV absorber, stabiliser
Eugenol UV absorber, stabiliser
Farnesol fragrance
Geraniol fragrance
Hexyl cinnamal fragrance
Hydroxycitronellal fragrance
Isoeugenol fragrance
Limonene fragrance
Linalool fragrance
Parfum fragrance
Octocrylene UV absorber, stabiliser

This study was conducted by the Danish Consumer Council, Dutch NGO Erase All Toxins and Flemish NGO Stand up to Cancer. They suggest that an alternative is to use perfumes that have been awarded the EU or Nordic Swan Ecolabels. A full document on the study can be accessed here.

 

Last Update: 2022-01-04

On November 15th, 2021, Taiwan’s EPA published a draft regulation that would restrict the production, import, and sale of flat packaging materials containing polyvinyl chloride (PVC). The draft regulation is based on Article 21 of Taiwan’s Waste Disposal Act. This draft regulation, "Restriction on the Production, Importation, and Sales of Plate Packaging Material Containing Polyvinyl Chloride (PVC), Designated Recyclable Containers and Non-plate Disposable Tableware Containers" is under public consultation and the deadline for comment is January 17th.  

Polyvinyl Chloride (PVC) is one of the most widely used polymers in the world. Due to its versatile nature, PVC is extensively used in everyday life. In the draft, several concerns about PVC usage are listed, including: 

  • Stabilizers are often added to PVC products to facilitate its heat resistance and this may be contaminated with heavy metal like lead or cadmium and may be hazard to human health.  

  • PVC material is not resistant to oil/soluble corrosion and has the possibility of plasticizers penetrating into food and increasing carcinogenic risks and exposures to environmental hormones.  

  • At the waste stage of PVC, dioxin may be generated after incineration and release of lead, cadmium and other heavy metals (due to addition of the stabilizer) into the air. 

According to the draft, from 1st of November 2022, PVC will be prohibited in plate packaging materials for animal food, dairy products, drinking water, seasonings and alcohol. Plate packaging materials, in the draft regulation, are defined as the plastic lining, blister, and plate containers. Plastic lining is the topless packaging material that is used to cushion and protect the substances or products contained inside, while blister containers are processed PVC plates used in the same way. 

PVCs and packaging materials containing PVC manufactured before 1st of November 2022 would not be affected by the ban. 

PVC packaging has been banned or restricted in a number of countries around the world, such as Canada, Spain, South Korea and the Czech Republic. Taiwan’s proposal for banning the use of PVC in plate packaging materials is a step further to this effort. EPA also mentioned it will steer industry toward alternative material and increase consumers’ awareness of the subject.  

 

Last Update: 2022-01-10

On the 16th of December 2021, the commission confirmed that the exemption for mercury in linear fluorescent (LFL) lamps and single capped (compact) fluorescent lamps will be revoked. This is because the uses of mercury can be sufficiently substituted in these lamps.

The commission also decided that this substitution will generate energy savings and stimulate innovation. The proposals have been submitted to the European Parliament and Council for a two-month scrutiny, during which the Parliament will either accept or reject the proposed drafts. If accepted, lamps containing mercury will have to phase out within 18 months from the implementation date. For the compact lamps, the earliest phasing-out period will be 12 months.

 

Last Update: 2022-01-12

On the 11th of January 2022, the European Commission granted a temporary exemption for the use of lead in the following electronic materials:

  • bismuth strontium calcium copper oxide superconductor cables
  • wires
  • and lead in their electrical connections

The commission also renewed Annex IV on the use of lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors for magnetic resonance imaging (MRI) devices.

Comments on these notifications are opened from 11th of January to 11th of March 2022. The notification drafts are expected to be adopted in March 2022 and will enter into force three months after adoption.

 

Last Update: 2022-01-12

The Ministry of Environment (MoE) in South Korea introduced 'Designation and Management of Substance Subject to Permission System' in 2015. This is to designate chemical substances with a risk of harm as substance subject to permission, and to give permission to manufacture, import, or use those substances.

A pilot project is being carried out to specify the procedures and methods for selecting, disclosing, and collecting opinions on candidate substances.

 

For the pilot project, 10 candidate substances subject to permission were selected as follows:

Substance name

CAS No.

Substances subject to intensive control

NIER’s No

Toxicity

Benzo[def]chrysene (Benzo[a]pyrene)

50-32-8

Appendix 1-2

CMR, PBT

Benz[a]anthracene

56-55-3

Appendix 2-7

CMR, PBT

Formamide

72-12-7

Appendix 1-16

CMR

p-(1,1-dimethylpropyl)phenol

80-46-6

Appendix 1-28

Endocrine disorders

Tris(2-chloroethyl) phosphate

115-96-8

Appendix 1-67

CMR

Sodium peroxoborate

7632-04-4

Appendix 1-125

CMR

Perboric acid, sodium salt

11138-47-9

Appendix 1-161

CMR

Sodium Tetraborate, Pentahydrate

12179-04-3

Appendix 1-164

CMR

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)

15571-58-1

Appendix 1-175

CMR

Trixylyl phosphate

25155-23-1

Appendix 1-181

CMR

 

If you have any opinion on candidate substances, please write your opinion and submit to yuhae@kcma.or.kr.

The deadline is January 20th, 2022.

 

Last Update: 2022-01-13

In December 2021, the European Commission adopted the proposal of a new EU Directive aimed at reducing environmental crime. This proposal defines new environmental crimes, obliges Member States to take criminal law measures and sets the minimum level for punishment.

The proposal has a newly set EU environmental criminal offenses (illegal ship recycling, illegal timber trade, illegal abstraction of water) and will make investigations and criminal proceedings more relevant and effective.

In the proposal, penalties have been set for companies that conduct illegal activities.  Some of them include the following:

  • Where the offense cause or is likely to cause death or serious injury to any person, the penalty must be at least for imprisonment of up to ten years.
  • Restoration of environment/nature within a selected period.
  • Denial of access to public funds and business procurement procedures.
  • Withdrawal of administrative permits and business practice disqualification

Fines are expected to be set by Member states to be no less than 5% of a company’s overall (worldwide) turnover. The commission will take the next step by submitting the proposal to the European Parliament and the Council.

 

Last Update: 2022-01-14

European Union (EU) 

A new Chemicals Strategy for Sustainability was presented by the EU in 2020 as part of the EU Green Deal. This year, there are major implementations that will be made to achieve this strategy as Europe transitions to a toxic-free environment. Below is a summary of the key updates to expect this year: 

Revision of the REACH regulation 

The EU plans to revise the REACH regulation this year and this will bring significant changes. A workshop held by the Commission in November 2022 deliberated on this topic and two more workshops will be held in March and June this year.  

New hazard classes and criteria for CLP Regulation 

Like the REACH regulation, the commission also plans to present new hazard classes and criteria for CLP Regulation. In October 2021, the commission specifically said it will revise Regulation (EC) No 127/2008 on hazard classification, labelling and packaging of chemical substances and mixtures (CLP regulation).  

New Proposal 

European Commission proposes to strengthen environment protection through criminal laws. In December 2021, the European Commission adopted the proposal of a new EU Directive aimed at reducing environmental crime. This proposal defines new environmental crimes, obliges Member States to take criminal law measures and sets the minimum level for punishment. 

PFAs restriction proposals

The other regulatory updates include new criteria set up for the concept of essential use and the submission of comprehensive PFAs restriction proposal by Denmark, Germany, the Netherlands, Norway, and Sweden. The regulation regarding the concept of essential use will ensure that the most toxic chemicals are only used if they are essential to health and the society. These are the updates you should look forward to in 2022 considering these changes will affect all chemical companies in the supply network from the manufacturers down to the downstream users. 

China

  • China’s NMPA announced children cosmetic working plan to come into force January 1, 2022. On the 1st of December 2021, China’s National Medical Products Administration (NMPA) published a special label for cosmetics that are intended for use by children under 12 years old. From 1 May 2022, newly registered children’s cosmetics must attach the logo. If the cosmetic is already registered or filed when the notification is published, companies must update their labels before 1 May 2023.   

  • The draft action plan for managing new pollutants might be finalised in 2022. In October 2021, the Ministry of Ecology and Environment (MEE) presented its draft action plan to manage new pollutants. The plan is expected to include priority chemicals’ new regulations, restrictions, and bans.  

  • The additional requirements added to the new cosmetics law in 2021 will take effect in 2022. Measures for the Supervision and Administration of Cosmetics production and administrative measures for registering and filing cosmetics took effect from January 1, 2022. Then, the administrative measures on cosmetics labelling will take effect from May 1, 2022.  

 

Japan 

  • Between now and May 24, companies in Japan have to comply with chemical classification, labelling and SDSs standards accordingly with the GHS sixth revised edition.  

 

Taiwan 

  • EPA extends the deadline of the first batch of PECs (106) to 2024 irrespective of their volume  

  • Companies are required to submit data for nine items to the authorities, with items eight and nine – hazard and exposure assessments – can be submitted later  

  • Annual Reporting requirement for Phase One Registration between April 1 to September 30   

  

Australia

In Australia, as a manufacturer/importer of chemicals, you are expected to make an annual declaration of the chemicals you manufactured or imported the previous registration year. For this year, the deadline remains 30th November 2022. Also, the deadline for renewal of registration is 31st August 2022. The renewal of registration applies if you as a manufacturer/importer continues to manufacture/import chemicals. 

For annual declaration, the information you need to submit include: 

  • the introduction categories for the chemicals you imported/manufactured during the registration year 

  • a declaration that all your introductions were authorised under sections 25 to 30 of the Commonwealth's Industrial Chemicals Act 2019. 

And for the renewal of registration, you need to submit: 

  • the value of the chemicals you imported/manufactured during the previous financial year 

  • if you are a foreign (non-Australian) business, you will need an Australian Registered Body Number (ARBN) 

India

  • Chemicals list under mandatory BIS certification has been updated to 52.  

  • An update on ICMSR is expected before June 2022 

 

South Korea 

  • The draft grace period issued for existing biocidal substances will end on 31st December 2022.  

  • The use of disposable plastic cups in cafes will be banned from April 2022. 

UK REACH 

For 2 years transition period, the deadline for registering substances (listed below) is on 27th of October 2023. Companies are expected to start their dossier preparation now.  

  1. >1000 t/a substances 
  2. ≥ 1 t/a CMR substances  

  3. ≥100 t/a very toxic to aquatic organisms 

  4. ≥ 1 t/a active Candidate list subs. as on 31 Dec 2020 

For 4- and 6-years transition period, the registration deadlines are 27th of October 2025 and 2027 respectively.  

Latin America  

Latin America has recently experienced intense developments in the chemical regulatory sector. Below is a short summary of these developments:  

  • Chile: GHS classification will be implemented in phases. Implementation of substances for industrial use is on February 9, 2022, and for non-industrial use, implementation is February 9, 2023. Also, for mixtures, implementation is on February 9, 2025, and February 9, 2027, for industrial and non-industrial uses respectively. 

  • Argentina: the new draft will be presented to Congress only after the elections (October-November 2021). 

  • Brazil: The Law Bill was presented in the Deputies Chamber in December 2019 and was approved by the Environmental Commission in December 2021. It still has to be approved by the other three Commissions. 

  • Chile – Implemented: Enacted in February 2021 by Decree 57. It is a mutual implementation of new GHS standards and chemical control policy. 1st notification deadline August 2024. Notification is mandatory every 2 years since then for ≥1 ton/ year. 

  • Colombia: Enacted in November 2021 by Decree 1630, it creates the National Chemical Inventory and enforces new chemical control measures for ≥100 kg per year. We are waiting for publication to know the correct deadline. 

  • Costa Rica recently joined OECD and as a requirement is starting to enhance the national chemical agenda. 

  • Mexico: The first version was published in 2019 and was expected to enter into force in 2021. However, the National Association of the Chemical Industry proposed changes in December 2020. 

  • Peru: Public consultation ended in September 2020. No information has been disclosed since then. The draft intends to implement the GHS and a national chemical regulation concomitantly.   

  • Uruguay adhered to the GHS standard; however, it did not announce or start drafting its chemical framework. 

The directorate of the Revolving Fund of the Ministry of Environment and Urbanization has published the 2022 KKDİK fee on its website.

Compared to 2021, the fees have increased by 20%. In 2021, the joint submission fee was lesser than individual submission. The registration fee currently varies from 60 TL/€4  (for SME companies that jointly register 1-10 tonnage) to 18,000 TL/€ 1167 (for large size companies that individually register 1000+ tonnage substance) depending on tonnage band, the size of the company, and whether it is a joint or individual submission. This indicates the importance of joint registration for companies.

If you haven't pre-registered your substances yet, kindly do, so you can be part of SIEF and also to participate in joint registration.

 

Last Update: 2022-01-18

On the 18th of January 2022, ECHA advises on how to determine and apply dose selection for dose and reproductive toxicity. This is in alignment with OECD guidelines. The director of ECHA for Hazard Assessment said the amended REACH annexes and the guidance instructions given by ECHA will help companies when doing toxicity tests to ensure that the correct dose level is used.

This advice is aimed at ensuring that test results reliably show whether a chemical has severe health effects or not. Furthermore, it prevents the repetition of inconclusive tests and animal suffering. REACH also has alternatives to animal testing for companies. This guidance document prepared by ECHA will be revised to consider the amended REACH annexes, therefore, the publication will be done later in the year.

Why is this guidance document important? Companies need to select the correct substance dose when doing toxicity tests of their chemicals’ safety as stipulated in the amended REACH annexes. This amendment applies from January 2022, therefore, companies will need as much guidance as possible to comply with this new rule.

According to ECHA, companies should:

(1) ensure that the data they generate from toxicity tests are suitable for hazards’ identification and risks’ assessment of chemicals.

(2) prevent the severe suffering of animals when conducting animal testing.

(3) Toxicity tests should be done at a high dose level that appropriately complies with the OECD test guideline.

The current guidance document can be accessed here.

 

Last Update: 2022-01-21 

The Candidate List of Substances of Very High Concern (SVHC) now contains 223 entries. On 17th January 2022, ECHA added four hazardous chemicals that are commonly used in cosmetics to the candidate list.

Under the REACH regulation, companies have obligations if their substances are included in the candidate list, either as a substance in mixture, or in articles.

Manufacturers and importers of articles have to notify ECHA, if their article contains a Candidate List substance, within six months from the date it was included in the list (17 January 2022). Suppliers of substances on the Candidate List have to provide their customers with a safety data sheet (SDS).

If the products contain SVHC in a concentration above 0.1 % (weight by weight), companies have to also notify to the SCIP database.

#

Substance name

EC number

CAS number

Reason for inclusion

1

6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol

204-327-1

119-47-1

Toxic for reproduction
(Article 57 c) 

2

tris(2-methoxyethoxy)vinylsilane

213-934-0

1067-53-4

Toxic for reproduction
(Article 57 c) 

3

(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC)

-

-

Endocrine disrupting properties (Article 57 f - human health)

4

S-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate

401-850-9

255881-94-8

PBT (Article 57 d)

 

Last Update: 2022-01-21

On 22nd December 2021, the Ministry of Environment and Ecology announced that 11 chemical substances will be added to the Inventory of Existing Chemical Substance list (IECSC) of China.

For chemicals included in the chemical inventory list, there is no compliance obligation for manufacturing or exporting them to China. But if chemicals fall under the new use management system, then they must comply with China REACH regulation according to general registration conditions. To check if your concerned substance falls under the new use management category, you can check it on GPC compliance advisor for free.

The 11 chemicals are as follows:

English names

CAS Numbers or Serial Numbers

3,4-Dimethyl-benzaldehyde

5973-71-7

4-Amino-N-(4-aminophenyl)

benzenesulphonamide

16803-97-7

4-(Trifluoromethyl)

benzoic acid

455-24-3

Propanoic acid, 2-hydroxy, C12-13-branched alkyl esters

1471312-26-1

N,N'-Carbonyldiimidazole

530-62-1

L-Alaninol

2749-11-3

Benzyl glycidyl ether

2930-05-4

1H-1-Benzazepine-1-acetic acid, 3-amino-2,3,4,5- tetrahydro-2-oxo-,1,1- dimethylethyl ester,(3S)-

109010-60-8

4'-Bromomethyl-biphenyl-2- carboxylic acid tert-butyl ester

114772-40-6

N-Phenyl guanidine

2002-16-6

6-Bromo-3-methyl-3H-

dibenz[f,ij]isoquinoline- 2,7-dione

81-85-6

 

For more information regarding China REACH and China regulations requirements, please contact us by email: compliance@gpcregulatory.cn (general business inquiry or zhengmin@cn.gpcregulatory.com (personal inquiry).

 

Last Update: 2022-01-21

Based on the China cosmetic regulation (Cosmetics Supervision and Administration Regulation, CSAR), the National Medical and Pharmaceutical Agency (NMPA) published the good manufacturing practice ‘specifications’ for cosmetics. This notification was published on 7th January 2022, and it is expected to come into force in July 2022.

With nine chapters and two attachments, the notification document details the requirements for the whole process of cosmetics production and usage, from the purchasing of raw materials to producing, experimenting, storing, selling and recalling cosmetics. It aims to ensure that high quality cosmetics are placed in the China market.

According to these specification requirements, it will apply to all companies that register or manufacture cosmetics in China. For those who secure manufacturing licenses or certificates before 1st July 2022, they are required to update their facilities, equipment, and management rules to meet the new specifications before 1st July 2023.

You can download the full specification requirements here. For more information or inquiry regarding China cosmetic regulations, you can email compliance@gpcregulatory.cn (for general business inquiry) or zhengmin@cn.gpcregulatory.com (for personal inquiry).

 

Last Update: 2022-01-21

Canada has embraced Volatile Organic Compound (VOC) directions for certain customer and commercial products, setting up the most extreme concentration limits in around 130 item categories.

Published in the Canada Journal this month, the Volatile Organic Compound Concentration Limits for Certain Items Controls will boycott the manufacture and import of products with VOCs exceeding their category-specific limits unless a permit is obtained, in an effort to diminish the arrangement of ground-level ozone.

Product types covered by them include certain:  

  • automotive and household maintenance products;  
  • adhesives, adhesive removers, sealants and caulks;
  • personal care products;  
  • other miscellaneous products.  

The VOC concentration limits will take impact on 1 January 2024 for all item categories. However, disinfectants have an extra year to comply. The regulations require manufacturers and importers of regulated products to keep certain records for at least five years, and to set out three alternative compliance options "to provide flexibility". 

 

Last Update: 2022-01-26

Transport Canada (TC) recently opened a discussion to revise Part 6 of the Transportation of Dangerous Products (TDG) and set new training requirements. 

Published in the Canada Gazette Part 1 on 11 December 2021, the recommendations aim at providing a more grounded system for the training oversight by removing the words ‘adequately prepared’ from the TDG Regulations and inputting references to the new standard CAN/CGSB-192.3-202- Transportation of dangerous goods training, assessment, and competency.

This new move is fostered by the increasing mindfulness of the existing training provisions that do not provide a vigorous body of rules. Although most stakeholders meet or surpass the training requirements, TC inspectors have noticed that some employees need to know more about the knowledge and skills needed to do this dangerous goods transportation, despite having a valid training certificate. TDG monitoring program discovered that 55 of the 409 dangerous good incidents (that resulted in injury or death between 2014 and 2019) were ascribed to the lack of proper and adequate training.

Transport Canada has been working for quite some years on the issue. It started a targeted consultation in 2016, including more than 100 agents from government, specialists, companies, industry affiliations and training suppliers, after which there was a more firmly focused consultation with 35 of the stakeholders; and after that, there was an open online meeting. After all these came the improvement of measures and propositions for regulatory revision.

 

Last Update: 2022-01-26

The Ministry of Environment (MoE) in South Korea published and distributed a guide to serious civic accidents caused by raw materials and products under the Serious Accidents Punishment Act (SAPA).

The SAPA regulates the punishment of business owners, chief executives, public officials, and corporations who cause casualties by violating their duty to take safety and health measures while operating business or workplace, public facilities, and public transportation, or handling raw materials or products harmful to the human body. This is to prevent serious accidents and protect citizens and workers.

The guideline is to help companies understand and support the establishment of a safety and health management system on serious civic accidents caused by raw materials and products. It includes an overview of the SAPA, the definition of raw materials and products, and the duty of chief executives to establish safety and health management systems, secure safety and health, among others. The guide can be accessed here.

 

Last Update: 2022-01-28

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