GPC Newsletter Feb-2021



Regulatory News

Proposition 65, known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. The proposition protects California's drinking water sources from being contaminated with chemicals known to cause cancer, birth defects, or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals. 

On December 2, 2020, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705. In this amendment, a proposition 65 No Significant Risk Level (NSRL) of 23 micrograms per day for the chemical p-chloro-α,α,α-trifluorotoluene (PCBTF) (CAS 98-56-6) was adopted. The regulation will be effective on April 1, 2021.  

Update: 2021-02-21

Grandfathering is a transitional arrangement under UK REACH that allows GB-based manufacturers and importers of a substance registered under EU REACH to continue to import or manufacture that substance in Great Britain past the end of the Brexit transition period. Provided that they submit some initial information on that substance, manufacturers and importers that qualify for grandfathering may then postpone the registration of their substance by 2, 4 or 6 years depending on its hazard profile and tonnage band.  

Companies qualify for grandfathering if: 

  • They are a GB-based manufacturers or importers; and  

  • They hold an EU REACH registration, or held an EU REACH registration and transferred it to an EU-based legal entity, at any point between 29th March 2017 and 31st December 2020 

Grandfathering allows GB-based legal entities to transfer their EU REACH registration into UK REACH, with no additional registration fee. To do so, they need to comply with the following requirements. 

  • Before 31st April 2021: 

  • open an account on Comply with UK REACH;  

  • submit initial data (evidence of their existing EU REACH registration, identity of the registrant, identity of the substance etc.); and 

  • submit any relevant information from their EU REACH registration dossier. 

  • Before 28th October 2023/2025/2027 (depending on the tonnage band and hazard profile of their substance, as displayed in the table below): 

  • submit registration data, as set out in art. 10 of UK REACH and EU REACH. 

 

Deadline 

Tonnage band 

Hazard profile  

28 October 2023 

1000 tonnes or more per year 

Carcinogenic, mutagenic or toxic for reproduction (CMRs) - 1 tonne or more per year 
Very toxic to aquatic organisms (acute or chronic) - 100 tonnes or more per year 
Candidate list substances (as at 31 December 2020) 

28 October 2025 

100 tonnes or more per year 

Candidate list substances (as at 27 October 2023) 

28 October 2027 

1 tonne or more per year 

 

 

If a company fails to submit the initial information before 31st April 2021, it will not benefit from the deadline extension of 2, 4 or 6 years. Instead, it will need to complete the full registration of that substance before placing it on the GB market, regardless of whether the substance is already registered under EU REACH. 

update: 2021-02-28

Northern Island (NI) is part of EU regulatory systems for chemicals to ensure frictionless movement of goods within the island of Ireland, whilst remaining within the UK customs territory. NI businesses will retain their current EU REACH status and obligations allowing them to maintain current supply chains to the EU/EEA.

Northern Ireland notifications is a light-touch notification system and is applicable to Great Britain-based importers, or downstream users, of qualifying Northern Ireland goods (QNIGs) registered under EU REACH by a company which is based in Northern Ireland and wants to maintain access to the Great Britain market (England, Scotland and Wales).

Great Britain-based importers, who:

  1. were importing before 1 January 2021, must submit information on the substances they import into GB from NI in quantities of a tonne or more. They must do this within 300 days of the end of the transition period
  2. intend to commence importing after 31 December 2020 must submit the required information before commencing importing

The notification and information can be submitted by either the GB importer or the NI supplier.

Businesses based in Northern Ireland and wishing to do this should first inform their GB customer of their intentions.

Update: 2021-02-27

The Eurasian Economic Commission has published an updated draft of the 2nd tier of Eurasian Technical Regulation TR 041/2017 on “Safety of Chemical Products” (Eurasia REACH). The draft is available for public discussion until the 1st of April 2021.

The 2nd tier of the regulation contains detailed information on the procedure of formation and maintenance of the register of chemical substances and the procedure of notification of new chemicals.

The reason for the delay of regulation’s 2nd tier adaptation and recent publication of an updated draft was due to the changes in Appendix No. 7, “Procedure for the formation and maintenance of the register”.  Appendix No. 7 contains a list of chemicals classified as carcinogens, mutagens, and reprotoxicants of hazard classes 1 and 2. This appendix was developed to facilitate the hazard classification procedure for industry representatives but created disagreement which resulted in a considerable delay in the adaptation of the entire regulation.

The TR 041 regulation was initially expected to enter into force 2nd of June 2021, however, the date will most likely be postponed. The new date of regulation’s entry into force depends on the date of entry into force of the 2nd tier documents.

 

The draft of the 2nd tier documents is available here (in Russian). 

Update: 2021-02-18

 

 

The Ministry of Environment and Urbanization in Turkey published an announcement about new functions added to the chemical registration system on February 15, 2021. 

With the new change, the voting function will be integrated into the KKS so that potential registrants can vote for the candidate through the system. Unless there is more than one candidate or ministry requires it, appointing Lead Registrant (LR) by voting is not mandatory. Candidates should communicate with other potential registrants for LR. 

After appointment, lead registrants can start notifying the Ministry about their positions from March 1st, 2021. 

The fee calculator function has been added to the system. The fee is calculated depending on the size of the firm, tonnage range, and joint/separate submission. 

Currently, on the system, all firms are regarded as big size firms, therefore, to benefit from a reduced fee, companies should change the size of the company and upload SME certificates that can be obtained from KOSGEB (Small and Medium Industry Development Organization website. After listing firms as small or medium-sized, it can benefit from a reduced registration fee. For foreign companies, it will require documents that show the numbers of employees and annual turnover. The fee can be paid through the online system and the Ministry is automatically notified.

GPC can undertake LR role to facilitate the registration process and communicate with other registrants. If you haven’t pre-registered your substance, please contact us and we will facilitate your participation in SIEF (including appointing LR and reduced registration cost, etc.). As your seamless extension in global regulatory compliance, GPC will act for your best interests. 

Update: 2021-02-15

 

On November 19th, 2020, the Standardization Administration of China (SAC) published the Guidelines for the Use and Control of Key Chemical Substances in Consumer Products (GB/T 39498-2020), with its effective date on June 1st, 2021.

The Guidelines provide principles and recommendations for the use and control of key chemical substances in consumer products, including product components, parts, accessories, packaging and instructions for use. Products which are subject to special regulation such as FCM, Medicine, Cosmetics, tobacco, military products are not included in its scope. The competent authorities to implement this Guidelines are National Standardization Management Committee.

A total of 117 chemicals have been identified and listed along with recommendations on controlling their use and scope i.e mostly the limits set on their content and release and migration limits.

The background for preparation of these Guidelines was recall notification of the EU and US for consumer products from China showed that more than half of the product recalls were due to the presence of hazardous chemicals. The main reason was the lack of national standards regarding the restriction of chemical safety hazards in China. So, in 2013 the China National Institute of Standardization in association with academia and industries started the process of drafting the “Restriction Requirements for chemical hazards in Consumer products”

  1. In 2014, the drafting group prepared and completed the initial draft standards
  2. In 2017, it was open for public consultation
  3. In 2020, the “Guidelines for the control of the use of key chemical substances in consumer products” was officially released.

GPC encourages companies to actively review the restricted substances list and related requirements for smoother exports.

Update: 2021-02-23

In late January, after a month of the implementation of the MEE Order.12, China’s Solid Chemical Waste Management Center (SCC) published the first notification of the first activity and annual report. This notification provides detailed the requirements outlined by the MEE Order 12. According to the notification, the following documents are required for submission.

 

First Activity Report

Annual Report

Scope of Notification

  1. Simplified and regular registration certificates obtained under MEE Order No.12.
  2. Regular registration certificates obtained under MEP Order No.7.
  1. Certificates specified with annual report obligation on certificate which obtained under MEE Order No.12.
  2. Certificates granted under Article 3 of MEP Order No.7.

Time Specification

Within 60 days after the first activity or the first time import and transfer to another processor. 

Before 30 April every year since the second year of obtaining the certificates.

Content Requirement

Actual implementation of first activity.

The actual implementation of producing, importation, emission, risk control and environmental management from last year.

Report Procedure  

  • Fill in relevant data
  • Print it in color and sign it
  • Scan it as PDF document
  • Upload it to the online registration system

(Note: no requirement for post the paper-based report with signature, but it is important to wait until the system shows that the report is successfully uploaded.)

Report Body and Place

Report to MEE.

Report at MEE Official website

(Note: the reporting channel is a new channel under MEE)

 

GPC is ready to assist companies in submitting First Activity and Annual Report to the MEE, and for further queries please contact us at compliance@gpcregulatory.com

Update: 2021-02-20

Chemical Regulations Updates in 2020

K-REACH

K-REACH requires registration for all existing chemicals manufactured and imported to South Korea in quantities exceeding 1 ton per year. Joint registration is mandatory under K-REACH unless the MoE authorizes a business for individual registration. Joint registration refers to forming a consortium consisted of several potential registrants to submit all necessary dossier for chemical substance registration under K-REACH. 

The first registration deadline under K-REACH is by 31 December 2021, which applies to those who manufacture and import existing chemical substances exceeding 1,000 tons per year, or carcinogenic, mutagenic, or reproductive toxins (CMR) more than 1 ton per year.

Over 17,045 substances were pre-registered by the end of January 2021, according to the Ministry of Environment (MoE) in South Korea. After the pre-registration, the next step is to join a Chemical Information Communicative Organization (CICO, corresponding to SIEF in EU-REACH) of a pre-registered substance and prepare registration dossier.

On 2 November, the MoE in South Korea announced the revised K-REACH rules. The reason is to ensure effective implementation of the K-REACH regulation. First, registrants can enjoy an extended deadline for change registration. The deadline is extended up to 1 year, and the authority's confirmation is required. Chemical Classification and Labeling standards between different ministries will be harmonized to enhance consistency. Finally, the government's registration fees will be exempted for SMEs manufacturing and importing 1-10 t/y, if they register their substances before 2022.

K-BPR

K-BPR, also known as the Consumer Chemical Products and Biocide Safety Management Law, regulates safe consumer products and biocidal products. Essential requirements for these regulations consist of chemical risk assessment and authorization. It took into force on 1 January 2019 and its recent amendment in 2020 which has been enforced since 1 January 2021.

The amendment includes that non-Korean manufacturer can appoint an Only Representative to register biocidal active substance. Dossier submission will be exempted once submitted for K-REACH compliance, and the MoE will disclose the chemical ingredients list in the detergents, air fresheners and disinfectants.

Trade status

According to UN Comtrade's analytics[1], India is the 8th largest chemical supplier to South Korea, indicating a continuous increase in export since 2013. To India, South Korea remains 6th largest chemical supplier following China, USA, Germany, Japan and Netherlands. DGCI analytics[2] shows that Organic chemicals are India's 3rd largest commodity exported to South Korea in recent years. 

Table 1. India's Exports of Chemical Products to South Korea[3]

Product

HS Code

Values in USD thousand

India's exports to South Korea

India's exports to the world

2017

2018

2019

2017

2018

2019

Inorganic chemicals

28

48,007

(3.0%)

48,626

(2.4%)

38,667

(2.1%)

1,618,040

2,034,897

1,820,208

Organic chemicals

29

376,685

(2.8%)

418,384

(2.3%)

447,218

(2.5%)

13,560,670

17,815,582

18,247,371

 

Summary

Given trade statistics in recent years, it can be expected that chemicals will continue to be one of the crucial commodities in the trade between India and South Korea. As South Korea has tightened chemical regulations for safe chemical use, it might become a potential barrier for Indian chemical exporters. The Indian exporters shall appoint the Only Representative with a legal entity in South Korea to prevent non-compliance and meet regulatory requirements. In order to comply with the relevant regulations, it is necessary to proactively inform Indian exporters the recent regulatory updates. Also, collecting industry opinions about challenges and recommendations would be helpful for regulatory improvement.

 

Last update: 2021-02-12


[1] https://comtrade.un.org/labs/data-explorer

[2] http://www.dgcisanalytics.in/dgcis/EXIM-Analytics

[3] https://www.trademap.org/Index.aspx?AspxAutoDetectCookieSupport=1

The Ministry of Health and Welfare in Taiwan circulated a list of Prohibited ingredients in Cosmetic Products on 3 December 2020. After 60 days of publication consultation, the list is now expected to come into force on 1 July 2021. Cosmetic products that contain these ingredients need to follow the instruction, otherwise it is banned from importing, manufacturing and selling. The legal base of this list is Cosmetic Hygiene and Safety Act.  

255 substances have been newly added to the list and the use of 40 substances in cosmetic products has been modified, most of them are prohibited in use in hair dyes related products. 

Another update from Cosmetic regulation in Taiwan is Taiwan's membership in International Cooperation on Cosmetics Regulation (ICCR). After four years as an observer member, from December 2020 Taiwan had officially become a member of ICCR, a voluntary international group of cosmetic regulatory authorities from Brazil, Canada, the European Union, Japan, the Republic of Korea, and the United States. The members meet on an annual basis to discuss cosmetics safety and regulation and have dialogues with cosmetics industry trade associations. 

Download the draft list 

update: 2021-02-11

The Brazilian Health Regulatory Agency (ANVISA) has been submitting several proposals of the country’s agrochemical standards to the WTO in February. All of the modification proposals are open to public consultation until April 4th, 2021.

These proposals can be seen as a part of the National Fertilizer Plan and the country’s determination to enhance registration of pesticides. Most of WTO notifications are related to the modification of Maximum Residue Limit (MRL), Safety Interval (SI), and Acute Reference Dose (ARfD).

The correlation of chemicals and modifications is displayed in the following table.

Monographic Index

Name

CAS #

Propose

T32

Tebuconazole

107534-96-3

Include coconut cultivation with MRL of 0.01mg/kg and a 1-day safety interval (foliar application)

T24

Trifluralin

1582-09-8

Include peas, cowpea, chickpeas and lentils, with MRLs of 0.05 mg/kg and oats, rye and triticale with MRLs of 0.01 mg /k, both in a pre-emergency application, thus no safety interval defined.

D06

Deltamethrin

52918-63-5

MRL change from 0.05 to 1.0 mg/kg in sorghum culture; inclusion for rice, beans, corn and wheat, with safety interval not determined

M32

Methoxyfenozide

161050-58-4

Soil application for sugar cane cultivation, MRL of 0.03 mg/kg, and acute reference dose of 0.9 mg/kg

E32

Spinetoram

187166-40-1

Soil application for sugar cane cultivation, MRL of 0.01 mg/kg, and undefined safety interval

S13

S-metolachlor

87392-12-9

Inclusion of non-agricultural use, in pre-emergence, along fences, fire breaks, roadsides, pipelines, railways and strip under high voltage power transmission lines

M19

Metribuzim

21087-64-9

Inclusion of non-agricultural use, in pre-emergence, along fences, fire breaks, roadsides, pipelines, railways and strip under high voltage power transmission lines

G01

Glyphosate

1071-83-6

Inclusion of açaí, Brazil nuts, macadamia, pinhão, pupunha, with MRL of 0.1 mg/kg and safety interval of 15 days; other cultivation modifications

A29

Acetamiprid

135410-20-7

Inform MRL and safety interval as "Non-food use" for pasture, in foliar application. Acute reference dose 0.025mg/kg of body weight

P31

Propaquizafop

111479-05-1

Acceptable Daily Intake 0.015mg/kg of body weight; Acute Reference Dose not applicable

A60

Abscisic acid

21293-29-8

Include rice culture with MRL and safety interval not determined in a foliar application; Acute Reference Dose not determined

F69

Flupyradifurone

951659-40-8

Inclusion of coffee, melon, cucumber, pepper and tomato crops, maintaining the MRL and IS currently approved for the respective crops for soil application

C60

Zeta-cypermethrin

52315-07-8

Inclusion sweet potatoes, beets, carrots, ginger, yams, parsnips, turnips and radishes cultivation with MRLs of 0.05 mg/kg and safety interval of 7 days for foliar application; Acute Reference Dose of 0.04mg/kg of body weight

S16

Saflufenacil

372137-35-4

Inclusion of millet and sorghum crops, with MRL of 0.01 mg/kg and oats, barley and triticale, with MRL of 0.01mg/kg, both with safety interval not defined because of pre-emergency application

P53

Protioconazole

178928-70-6

Include corn crop in seeds modality, with safety internal not determined due to the type of use

C09

Cymoxanil

57966-95-7

Include the soybean crop, with MRL of 0.01 mg/kg and a safety Interval of 30 days for foliar application

F36

Flutriafol

76674-21-0

Change the MRL for onion culture from 0.1 mg/kg to 0.2 mg/kg

P13

Profenofos

41198-08-7

Inclusion of cowpea, fava beans, chickpeas and lentils with MRL of 0.1 mg/kg and a safety interval of 14 days for foliar application

C61

Beta-cyfluthri

68359-37-5

Change the MRL from 0.1 to 0.3 mg/kg and the safety interval from 21 to 3 days for the citrus crop, and change the MRL from 0.1 to 0.2 mg/kg for the tomato crop

C49

Carfentrazone-ethyl

128639-02-1

Changing the safety interval from 30 to 7 days for the soybean crop in the desiccation mode, maintaining the currently approved MRL

F23

Fluazifop-P

83066-88-0

Change MRL for beans from 1 mg/kg to 7 mg/kg and the safety interval remains of 60 days; Defines methodology for conformity

 

 

 

The agency also included de following chemicals/organisms in the list of the active ingredients of pesticides, household cleaning products and wood preservatives:

Monographic Index

Name

CAS #

N12

Neoseiulus barkeri

-

T72

1-Tetradecanol

112-72-1

D56

Z,E-7,9,11-Dodecatrienyl Formate

146321-32-6

A64

7-Dodecen-1-ol

16677-06-8

T71

Thiencarbazone-methyl

317815-83-1

C58

Alpha-cypermethrin

67375-30-8

C18

Chlorothalonil

1897-45-6

 

Among the substances highlighted previously, only C58 and C18 underwent changes in cultivations, of which are summarized as

Monographic Index

Name

CAS #

Alteration

C58

Alpha-cypermethrin

67375-30-8

The SI for 14 days in the cotton culture and the MRL for 0.15 mg/kg; include peanut culture with 15 days SI and MRLs of 0.05 mg/kg; change the SI for 14 days in the rice culture and the MRL for 2.0 mg/kg; change the SI in the potato culture for 3 days; include in the culture of sugarcane the foliar use modality with SI of 189 days; change the SI in the bean culture for 15 days and change the SIS in the tomato culture for 1 day; Acceptable Daily Intake (ADI) = 0.02 mg / kg of body weight; ARfD = 0.04 mg/kg of body weight.

C18

Chlorothalonil

1897-45-6

Cultures of broccoli, kale, Chinese kale, Brussels sprouts and cauliflower, with MRLs of 0.5 mg/kg and SI for 7 days, sweet potatoes, yacon-potatoes, beets, yams, ginger, yams, cassava, parsnips, turnips and radishes, with MRLs of 0, 2 mg/kg and 7 day SI; include pea, cowpea, chickpea and lentil crops with 2.0 mg/kg MRL and 14 days SI; all with foliar application. The chemical is can be also used to cultivate duboisia for non-food use. The method for conformity is defined.

 

Interested parties can submit suggestions by e-mail cp.toxicologia@anvisa.gov.br using this form.

Update: 2021-02-20

Vietnamese National Chemical Inventory (NCI) Notification window opened on 16th October 2020 and is about to close on 15th April 2021.

Vietnam began to compile the national chemical inventory (NCI) in 2012. Substances that are not listed on the inventory will be considered as new substances and require registration before they can be used, imported, or produced in Vietnam. So far, there are 5 times where companies can nominate substances to the inventory. The inventory contains about 40,000 substances. The new deadline for substance submission is April 15th, 2021. The final draft of the inventory is expected to be released by the end of this year.


If companies are exporting to Vietnam then for a smooth continued trade and to avoid heavier regulatory obligations later-on enterprises are encouraged to submit information on chemicals that have been imported, manufactured, and used in Vietnam.

The information required for submission are:

  1. Chemical name,
  2. CAS registry number,
  3. Safety Data Sheet,
  4. Proof of the chemical used in Vietnam (including purchase contracts, invoices, or custom forms).

GPC through its Vietnamese affiliates can help you with an end-to-end compliance solution for Vietnam! 
 

Update: 2021-02-28

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