GPC Newsletter Mar-2021


Announcement

Due to the consistent growth in business during the past few years, we are delighted to expand our regulatory service to Australia. We are now able to provide Australian Industrial Chemicals Introduction Scheme (AICIS) related services, including registration, categorization, and annual reporting.

To introduce AICIS and related services, GPC will have two webinar events on April 12 and April 23 at 11:30 (CEST)/15:00 (IST).

For AICIS related services and questions, please contact us at compliance@au.gpcregulatory.com

GPC summarizes the key deadlines for chemical compliance in 2021 and can provide regulatory support worldwide and end-to-end solutions for chemical and agrochemical regulatory compliance.

 


Regulatory News

In the context of the authorization process, Member States Competent Authorities and/or the European Chemicals Agency (ECHA), on request of the European Commission, could prepare Annex XV dossiers for the identification of Substances of Very High Concern (SVHC).

Substances that may have serious and mostly permanent effects on human health and environment can be recognized as substances of very high concern (SVHCs) and can include substances which are:

  • Carcinogenic, Mutagenic or toxic to Reproduction (CMR),
  •  Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB)
  •  Also, those substances which are identified, on a case-by-case basis, from scientific evidence that causing likely severe effects to human health or the environment (e.g. endocrine disrupters)

When a substance is recognized as SVHC, it will be added to the Candidate List and further eventually it will be included in the Authorisation List.  Following are the substances that are listed and may be included in the Candidate List. Proposals have been sent to submit the comments during the consultation.

Name

EC Number

CAS Number

Proposing authority

Reason for proposing

Date of publication

Deadline for commenting

1,4-dioxane

204-661-8

123-91-1

Germany

Equivalent level of concern having probable serious effects on the environment (Article 57f)
Equivalent level of concern having probable serious effects on human health (Article 57f)

09/03/2021

23/04/2021

2,2-bis(bromomethyl)propane1,3-diol (BMP)
2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA)
2,3-dibromo-1-propanol (2,3-DBPA)

221-967-7
253-057-0
202-480-9

3296-90-0
36483-57-5
1522-92-5
96-13-9

Norway

Carcinogenic (Article 57a)

09/03/2021

23/04/2021

2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers

-

-

Sweden

Toxic for reproduction (Article 57c)

09/03/2021

23/04/2021

4,4'-(1-methylpropylidene)bisphenol; (bisphenol B)

201-025-1

77-40-7

France

Endocrine disrupting properties (Article 57(f) - environment AND human health

09/03/2021

23/04/2021

Glutaral

203-856-5

111-30-8

Sweden

Respiratory sensitising properties (Article 57(f) - human health)

09/03/2021

23/04/2021

Medium-chain chlorinated paraffins (MCCP) [UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17]

-

-

ECHA

PBT (Article 57d)
vPvB (Article 57e

09/03/2021

23/04/2021

Orthoboric acid, sodium salt

237-560-2

13840-56-7

Sweden

Toxic for reproduction (Article 57c)

09/03/2021

23/04/2021

Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP)

-

-

Germany

Toxic for reproduction (Article 57c)
Endocrine disrupting properties (Article 57(f) – human health)
Endocrine disrupting properties (Article 57(f) – environment)

09/03/2021

23/04/2021

The European Chemicals Agency (ECHA), on behalf of the European Commission (EC), is running its fifth project under the Instrument for Pre-Accession Assistance (IPA). These projects are targeted at assisting European Union (EU) candidate countries to prepare for the obligations of EU membership, in this context specifically regarding chemical safety regulations. They have the overall aim to equip candidate countries with the knowledge necessary to fully participate in the implementation of EU chemicals policy and, in the responsibilities that ECHA shares with MSCAs.

Since 2009, ECHA has implemented four IPA projects focused on explanatory and training events for the authorities of Montenegro and Serbia. The Agency's main goal is to provide technical support to develop these countries’ understanding of ECHA's regulatory activities and facilitate the alignment of their national legislations with the EU regulatory framework.

To increase the impact of ECHA’s general support activities (such as site visits, specific training and participation in ECHA events), the Agency has contracted an in-depth assessment of the legal and institutional capacities of both countries.

The main challenges lie with the limited financial, human and IT resources currently available for the accession countries to implement and enforce the REACH, CLP, BPR and PIC regulations. The study recommends strengthening the administrative capacity of the national authorities, ensuring enough financial resources to implement and enforce the legislation, facilitating cooperation with academia as well as increasing communication activities and IT capacity. 

The national plans outline several actions for Montenegro and Serbia as well as EU Member States and ECHA ahead of a future membership. ECHA stands ready to continue supporting the countries through training and capacity building on risk assessment, IT security and tools, and enforcement.

 

Last update: 2021-03-31

 

Biocidal Products Committee(BPC) is a committee of ECHA which forms opinions on the BPR process and each member state appoints one member for BPC. Members of BPC meet regularly to discuss and the agenda for those meetings are published 21 days before the meeting.  

In the meeting, BPC proposes not to approve four silver compounds saying that the risks for human health, the product-type 4 (food and feed area) are:

  • silver zinc zeolite;
  • silver zeolite;
  • silver copper zeolite; and
  • silver sodium hydrogen zirconium phosphate.

Those substances can be found in kitchen utensils since they are all used to prevent cross-contamination. Also, silver copper zeolite and silver sodium hydrogen zirconium phosphate can be found not only in kitchen utensils but also in water because carbon water filters contain silver zinc zeolite and silver zeolite to prevent bacterial growth and when people use that filtered water to cook or drink, they can be exposed. Consequently, All substances have both commercial and non-commercial applications.  

It is concluded that those substances can’t be used as a disinfectant in food and feed area. For the first time, BPC made a decision considering all the exposure to a substance from many sources not only the use in question.  

Last update: 2021-03-31

The Ministry for Development of Economy, Trade and Agriculture of Ukraine has notified the draft resolution, On Approval of the Technical Regulation on Safety of Chemical Products, to the WTO. This draft resolution lists out requirements for registration, assessment, authorization and restriction of chemicals and will come into force after the adoption of the Law of Ukraine “On Chemical Safety”.

The draft Resolution aims to bring the provisions of the Technical Regulation in line with Regulation (EC) No. 1907/2006 of the European Parliament and of the European Council of 18 December 2006 on REACH and sharing the goal of improving the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances.

The adoption of the technical regulation implies that all chemical substances presented in the Ukrainian market are subject to compliance with this regulation. The responsibility will be upon Ukrainian manufacturers, importers as well as to non-Ukrainian manufacturers and exporters who circulate substances in Ukraine. However, there are some exceptions such as substances in transit.

According to the draft regulation, the State Service of Ukraine for Food Safety and Consumer Rights Protection will be responsible for the implementation and compliance with the regulation. No dates have been confirmed for implementation at this stage.

 

With the implementation of MEE Order No.12, more and more chemical substances are adding into the Chinese Inventory. On March 17th, 2021, the Ministry of Ecology and Environment of China (MEE) announced that they will add the third batch of chemical substances to the ‘Inventory of Existing Chemical Substances in China’.

MEE reviewed the submissions based on their roles listed in the ‘Notice on the Supplementing and Improving of the  Inventory of Existing Chemical Substances in China’. Among all the requests, 204 chemical substances met the Notice and MEE Order No.12 Article 3 requirements.

In terms of the principle of openness and accepting public supervision, MEE published the 204 chemical substances. See the list here. People can check and provide their opinions regarding those chemical substances from 17th of March to 30th of March. After the public consultation, the chemical substances will be listed in the Inventory formally.

For further information, please check our previous newsletter regarding china REACH or contact us by email: compliance@gpcregulatory.com.

 

Update: 2021-03-29

On 23rd March 2021, Chinese National Medical Products Administration (NMPA) launched a new platform for the registration and filing of cosmetics to support the implementation of ‘Cosmetic Supervision and Administration Regulation (CSAR)’ and ‘Measures for Registering and Filing Cosmetics’,

The platform will be launched in two steps. From 1st of April, the module of ‘information management system’ will be available and users can create accounts on this platform and manage their business information. From 1st of May, the module of record filing and registration of general and special cosmetics will be available. Users can then submit their applications according to NMPA’s data requirements.

In complying with the  CSAR, the platform supports both registration and record filing. For special use cosmetics and new ingredients, Applicants of those dealing with special use cosmetics and new ingredients are required to comply with registration. As for the general use of cosmetics and ingredients, applicants only need to submit record filing. These requirements are applicable to Chinese and overseas applicants.

For further information and inquiries, please contact us at compliance@gpcregulatory.com.

 

2021-03-31

Persistent Organic Pollutants (PoPs) will be added to the priority control substance list under K-REACH. The Ministry of Environment in South Korea published the national PoPs management plan on 28 January. However, the implementation date is not yet decided.

According to this new plan, manufacturers producing products with priority control substances will need to submit an additional report. The new national plan applies to the years 2021-25 and the substances that are subject to this new plan includes PCBs, PFASs e.g. perfluorooctanoic acid (PFOA), and perfluorooctanesulfonic acid (PFOS). 

 

Last update: 18 March 2021 

 

The Ministry of Environment (MoE) in South Korea has announced late pre-registration criteria on 23 February. Existing substances are chemicals that have been circulated in South Korea before 1991 or nominated by the MoE after the hazards assessment. The initial pre-registration was 30 June 2019.

Late pre-registration is allowed when:

  • A company is manufacturing/importing existing substances more than one tonne per year for the first time in South Korea
  • The existing substances that the ministry has added to the inventory recently
  • The importers initially notified the existing substance but OR will proceed with full registration

Companies that have done pre-registration can continue to manufacture or import chemicals without registration. The first full registration deadline is December 2021, for existing chemicals manufactured or imported more than 1000 tonnes per year and CMR substances manufactured or imported more than 1 tonne per year. 

 

Last update: 18 March 2021 

The Hazardous Substance Act B.E. 2535 is one of the main legislative bases involved in chemical management in Thailand. The first issue of B.E. 2535 came into force on April 7th, 1992. The Act has been revised several times. The Ministry of Industry (MOI) in Thailand, the main authority responsible for the Act, has approved the 5th revision in early 2021 and it will be announced soon.

As a part of the revision, there are several upcoming amendments, including more substances are being added to the inventory and announcement of the Draft of MOI Notification on the declaration of the List 5.6 hazardous substances and The Draft of MOI Notification on R&D Exemption B.E. 2559.

For controlling purposes and administrative reasons, the Hazardous Substance Act B.E. 2535 divides chemicals into 4 types according to the severity of toxicity (see graph below). Manufacturers and importers of hazardous substances exceeding 1 ton per year are required to notify their hazardous substances to the Department of Industrial Works (DIW) via DIW's online system. The notification shall be submitted within 60 days from the date of manufacture or importation (only once). This notification is also called Thailand Chemical Inventory Notification.

The chemical inventory in Thailand is called Thailand Existing Chemicals Inventory and it has been published on an online platform http://inventory.diw.go.th/hazardous61/. The inventory includes 11,481 entries. Users can search chemicals via Chemical name, molecular formulas, hazardous substance type, chemical type, CAS number or chemical code. The search results, as well as the entire inventory, could be exported and downloaded as a PDF or Excel document. The substance information in the inventory also includes the import quantity, production volume, and the physical/health/environmental hazards of the substance. As a part of the upcoming amendment, the Thailand government will add more substances to the existing chemical inventory.

According to the Draft of MOI Notification on the declaration of the List 5.6 hazardous substances, manufacturers or importers of substances or mixtures which have the total amount of the single substance in all products> 1,000 kg/year must provide the information in compliance with the WoAo/AoKo20 Form (currently, it is mandatory if the total amount of the product exceeds 1000 kg/year).

The Draft of MOI Notification on R&D Exemption B.E. 2559 will be revoked and replaced with the new one, the changes including applicants need to mention R&D & for education, testing, and analysis in their application. The volume remains the same as the current one, which is more than 1 kg. As for Type 2 substance, no notification and registration are required. As for type 3 substances, no licensing and registration are required. Applications need to comply with the GHS classification and labelling. The certification will be valid for 6 months and no possibility for renewal.

Following are the upcoming updates in the chemical management in Thailand that we can expect:

  • According to the Amendment of the declaration of the List 5.6 hazardous substances, declaration will be required for single substance, rather than just a product.
  • It will be new measurements for new chemicals such as Cut-off date (chemicals being introduced to Thailand), Chemical Analysis, and Chemical Risk Assessment.
  • Review the classification of hazardous substances (update List of Hazardous Substances No._ (B.E. 256X))
  • The new Hazardous Substance Act (the latest amendment) will be reviewed by parliament.
  • Amendment of the related regulations by The National Committee on Strategy Development for Chemical Management amend Master Plan on Chemical Management (2019-2037) https://online.fliphtml5.com/bcbgj/cklz/#p=3
  • We see chemical management in Thailand in line with the classification and prioritization of management of hazardous substances.

Last update: 2021-03-30

Brazil is the world’s largest user of pesticides and has been the market for many agrochemical companies. The Brazilian Health Regulatory Agency (ANVISA), agency responsible for toxicological assessment, submitted several modification proposals regarding pesticides and their residues. Such proposals are open to public consultation with different deadlines. 

     

Propose / Changes

Monographic Index

Name

CAS #

Cultivation

MRL (mg/kg)

SI (days)

ARfD (mg/kg) of body weight

Purpose

C59

Beta-cypermethrin

65731-84-2

Millet

0.05

14

-

-

Sorghum

1.00

14

-

-

F47

Fluazinam

79622-59-6

Peanuts, chickpeas and lentils

0.1

-

-

-

Peas and cowpea

0.1

-

-

-

Soy

0.02

-

0.07

-

I05

Iprodione

36734-19-7

Oat

2

5

 

Foliar

Barley

2

-

NA

-

C10

Cypermethrin

52315-07-8

Sweet potatoes, yacon potatoes, beets, yams, carrots, peas, beans, ginger, chickpeas, yams, lentils, parsnips, turnips, and radishes

-

14

-

Foliar

Peanuts

-

14

0.04

-

Beans, chickpeas, and lentils

0.05

-

-

Yacon potatoes, yams, peas, turnips, and radishes

0.05

-

-

T54

Trifloxystrobin

141517-21-7

Coconut

0.01

1

-

Foliar

Pumpkin

0.02

1

NA

Foliar

 

 

 

 

 

 

 

 

A41

Amicarbazone

129909-90-6

Pasture

NFU

NFU

0,1

Pre-emergence

P61

Piroxasulfona

447399-55-5

Peanuts, potatoes, barley and sunflower

0,02

NA

-

Pre-emergence

Tabacco

NFU

NFU

I18

Isoxaflutole

141112-29-0

Cotton

-

NA

NA

Pre and pos-emergence

L05

Lufenuron

103055-07-8

Cotton

-

14

-

-

Beans

21

Corn

35

Soy

21

N13

Neochrysocharis formosa

-

Included as a new organism

B26

Bifenthrin

82657-04-3

Cotton

0,06

-

-

-

Acerola, blackberry, cocoa, cupuaçu, raspberry, guarana, kiwi, passion fruit, blueberry, strawberry, cherry and pomegranate

0,01

14

0,01

Foliar

M17

Methomyl

16752-77-5

Avocado, cocoa, cupuaçu, guaraná, kiwi, papaya,

0,01

14

-

Foliar

mango, passion fruit, melon, watermelon and pomegranate

Acerola, blackberry, raspberry, blueberry, strawberry and pitanga

0,015

S13

S-metolachlor

87392-12-9

Sorghum

0,01

NA

-

Pre-emergence

MRL - Maximum residue level; SI - Safety interval; ARfD - Acute Reference Dose; NA - not applicable; NFU - Non-food use 

 

Further, the agency published on March 17, 2021, on the official gazette the new adoptions for 12 agrochemicals: 

     

Changes

Monographic Index

Name

CAS #

Cultivation

MRL (mg/kg)

SI (days)

ARfD (mg/kg) of body weight

Purpose

D06

Deltamethrin

52918-63-5

Sorghum

1

30

-

Storage

1

-

-

Application

T33

Teflubenzuron

83121-18-0

Peppers, eggplant, scarlet eggplant, okra and pepper

0,15

7

NA

-

A53

Aminopyralid

150114-71-9

Sugar cane

0,01

NA

0,26

Pre and post-emergence

M17

Methomyl

16752-77-5

Forage cactus

NFU

NFU

0,02

Foliar

B54

Bixafen

581809-46-3

Beans

0,07

15

0,2

Foliar

T14

Thiophanate-methyl

23564-05-8

Ornamental plants

NFU

NFU

-

Foliar

C64

Clothianidin

210880-92-5

Corn

-

21

0,6

Foliar

D17

Diflubenzuron

35367-38-5

Cotton, corn and soy

0,3

-

NA

-

F20

Phosphine

7803-51-2

Soybean meal

0,01

-

NA

-

A26

Azoxystrobin

131860-33-8

Chard, watercress, almond, chicory, spinach, stevia,
mustard, arugula,

1

7

-

Foliar

Duboisia

NFU

NFU

-

Foliar

M02

Mancozeb

8018-01-7

Rye and barley

1,5

32

-

Foliar

Millet

0,4

30

-

Foliar

Caupi beans, fava beans, guandu beans, mungo beans

0,3

14

-

Foliar

Cotton

1,5

-

-

Foliar

Wheat, oats and barley

1,5

-

-

Foliar

I29

Isofetamid

875915-78-9

Included as a new substance

MRL - Maximum residue level; SI - Safety interval; ARfD - Acute Reference Dose; NA - not applicable; NFU – Non-food use 

The country has been breaking the annual pesticide registration record since 2016. In 2020 alone, 493 new registrations were made. Besides de country be the largest consumer, it is the main market for highly hazardous pesticides (HPP). 

The activity can be seen as a continuation of the revision tasks started in February 2021, and present a strong link with the new National Fertilizer Plan proposal, scheduled for the 2nd or 3rd quarter. 

Interested parties have 60 days (counted from the publication) to submit suggestions by e-mail cp.toxicologia@anvisa.gov.br. Further information is available on ANVISA’s webpage.  

last update: 2021-03-31

The Law Bill 6.120/2019 is in possession of the Environment and Sustainable Development Commission (CMADS) of the Deputies’ Chamber since early December 2019, aiming to create the National Inventory of Chemical Substances in order to consolidate an information base on chemical substances produced or imported into the country. 

After 15 months long waited, the legislation received a designated rapporteur only in March 2021 and had a five-meeting deadline for amendments established. After CMADS, the bill has three more commissions to go before enters into force. The Law Bill 6.120/2019 is expected to pave the way for a national chemical policy. 

The proposal is part of the country’s ambition to develop a sound management of chemicals, given the international trend. On a regional context, Chile was the first country in Latin America to publish guidelines for its national inventory back in February 2021. 

 

Last update: 2021-03-31

 

On February 9, 2021, Chile approved its rules for the classification, labeling, and notification of dangerous chemical substances and mixtures (Decree 57) in the official gazette. The Decree 57 was promulgated in November 2019 and communicated to the WTO on 10 February 2021.

The new legislation targets manufacturers and importers of chemicals and dangerous substances that are not supervised by other regulations. 

Notifiers are requested to provide information on chemicals when dealing with 1 ton per year or above via the environmental authority portal. The notification is made on a biennial basis concerning the import or produced quantity every two year with the deadline on August 30th.

According to the law, applicants for substances for industrial use have three years to submit their first notification. As for substances for non-industrial use, it allows four years to notify. The recent deadlines are summarized below:

Substance type 

1st notification in 

Due date 

Industrial use 

3 years 

February 9, 2024 

Non-Industrial use 

4 years 

February 9, 2025 

 

Decree 57 also further outlines the compulsory compliance of GHS in the country, a standard until then has been voluntary. The country has taken a step forward and decided to apply the standard to both industrial and consumer products. 

 

The GHS standards will phase-in following the periods:

 Substance type 

Substances 

Mixtures 

Industrial use 

1 year 

4 years 

Non-industrial use 

2 years 

6 years 

In South America, Chile was the first country to join OECD and the first to implement and mandatory national inventory. It can be expected that other countries in the region will soon follow up and update their chemical agenda. 

Latest update: 2021-03-30

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