GPC Newsletter Jul-2021



Regulatory News

Performance measurement evaluations provide Canadians with information on the effectiveness of the risk management actions in place for the substances that are found to be toxic under the Canadian Environmental Protection Act, 1999 (CEPA 1999). The risk management, human health, and environmental objectives are systematically evaluated using robust data and expert analysis under this plan.

Performance Measurement Evaluation report has been published for Bis (2-ethylhexyl) phthalate having a CAS Registry Number 117-81-7.

DEHP was first assessed by the Government of Canada in 1994, where it was concluded that DEHP may enter the environment in a quantity or concentration or under conditions that may constitute a danger in Canada to human health. Risk management tools (Cosmetic Ingredient Hotlist [2009], the Phthalates Regulations [2011], reporting of DEHP content under the Medical Devices Regulations [2008], and provisions under the Food and Drugs Act [1985]) were established to help reduce exposure of DEHP to the general population of Canada in these products.

Overall, risk management tools are intended to meet their goals. Biomonitoring data was collected from three cycles (2007 to 2017) of the Canadian Health Measures Survey (CHMS) which indicates that Canadians’ exposure to DEHP has progressively decreased since risk management tools were adopted.

The performance measurement evaluation recommends ongoing measurement of DEHP in the CHMS and monitoring of the Phthalates Regulations. Ongoing reporting of DEHP concentrations in medical devices is also recommended.

Concluded details on the Performance Management Evaluation for DEHP can be accessed at Performance Measurement Evaluation for Risk Management of Bis(2-ethylhexyl) phthalate (DEHP), Health Component.

 

Latest update: 2021-06-30

Environment and Climate Change Canada (ECCC) has suggested federal environmental quality guidelines (FEQGs) for aluminum, selenium, and octamethylcyclotetrasiloxane (D4). For this, a draft has been set out for the threshold levels acceptable in the environment for these substances.

FEQGs have laid down concentration levels for these chemicals below which the government assumes that there is a low likelihood of adverse effects on aquatic life or animals in the food chain.

The use of these set guidelines is voluntary unless they are integrated into other regulations. However, they can be used in environmental monitoring, risk management as well as performance measures of these chemicals.

The ECCC has suggested an equation to calculate a site-specific FEQG for aluminum, based on a fresh water body’s level of dissolved oxygen, pH, and water hardness. For selenium, the department has set separate guideline values for fish egg ovary tissue (14.7µg/g), fish whole body tissue (6.7µg/g) and bird eggs (11µg/g). 

Suggested target for D4 in water is 0.2µg/L. 

Comments would be accepted on the proposed threshold by August 11.

Reference: Chemical Watch

Latest Update:  2021-06-15

Significant New Use Rules (Snur) draft guidance was released on 10 December 2020 to help businesses understand and comply with a TSCA Snur. This is the guidance that defines what qualifies as ‘surface coating’ under the rule and the entities subject to the rule’s requirements. So far, no substantive change has been made to the guidance. 

However, alongside the new reporting rule proposed by EPA, the Snur guidance issued earlier this year was revoked. This guidance was released in the final weeks of Trump’s administration. According to the agency, it has “inappropriately narrowed the scope and weakened the prohibitions included in the Snur.”  

Most importantly, the rule is still in effect as only the guidance was revoked. The Significant New Use Rules (SNURs) says: 

  • Companies must get the EPA approval before they can recommence the use of more than a dozen long-chain perfluoroalkyl carboxylate (LCPFAC) substances and perfluorooctanoic acid (PFOA). 

This rule also applies to imported articles containing compounds in a surface coating; this includes automotive parts, carpet, furniture, and electronic components. EPA also noted, during its announcement, that three PFAS have been added to the Toxics Release Inventory (TRI) in the early month of June. Also, the release of these chemicals will be reported by 1 July 2022 for 2021 calendar year data. The addition of these PFAS is made towards implementing the vitasl PFAS requirement of the NDAA. The NDAA, in line with the TRI Reporting Year 2021 directly added these three PFAS to the TRI list because they are subject to a SNUR under TSCA.  

 

Sources: United States Environmental Protection Agency 

 

Date: July 5, 2021 

On the 10th of June, EPA proposed a new Per- and polyfluoroalkyl substances (PFAS) reporting rule after the White House Office of Management and Budget cleared it. For producers and importers, this new rule means that they have to supply extensive information on 1,300 plus substances that have been used in the US over the last 10 years.  

Producers and importers of substances need to take note, as this is vital to future regulatory actions. The rule encompasses by-products, impurities, and articles that contain compounds. And affected parties are expected to disclose information regarding their use of any of the compounds. This information should include by-products, chemical identity, use classifications, quantity generated and processed, environmental and health impacts, worker exposure counts and lengths, and disposal.  

EPA said it verified 1,346 PFASs on the TSCA inventory as of April 2021, and 669 are active in the US commerce. A one-year reporting timeline has been suggested by EPA, which will follow the enactment of a final rule by 1 January 2023. This is following the National Defense Authorization Act (NDAA) of the US. 

According to the agency, this effort is targeted at collecting detailed information and having a comprehensive dataset on PFAS manufactured in the US. Producers and importers of substances should take note, as this is vital to future regulatory actions. Furthermore, it will help reduce potential risks caused by these chemicals.  

For the next 60 days (following publication in the Federal Register), EPA is open to comments about this proposal with a particular interest in the following: 

  1. identifying PFASs for reporting and whether imported articles containing them should also be covered 

  1. issues for economic assessment, especially regarding implicated small businesses and other manufacturers or importers of these compounds or articles containing them 

  1. the six-month submission period’s start date and duration, partially based on the CDR submission period 

  1. requirements possibly repeating what the agency has gathered under TSCA or other laws 

  1. the extent and format of collected environmental and health details 

  1. proposed data elements’ scope and whether the agency should ask for additional ones 

  1. how else it may utilize or publicize received information 

  1. whether it should permit joint submissions when the supplier, producer, or importer is unaware of a substance’s identity or ingredients; and 

  1. how the agency could facilitate small firms’ compliance, such as through outreach or adjusted reporting timelines. 

You can access the comment section via: www.regulations.gov 

Sources: United States Environmental Protection Agency  

Date: July 5, 2021 

In August 2020, the 5th draft of the Chemicals Management & Safety Rules (CMS Rules) was published by the Government of India. These draft rules are based on the EU REACH legislation and the existing Manufacture, Storage and Import of Hazardous Chemical Rules (MSIHC) 1989 and THE CHEMICAL ACCIDENTS (EMERGENCY PLANNING, PREPAREDNESS, AND RESPONSE) RULES, 1996. This new draft is progressively forward-looking and lays optimum emphasis on data. “No Data, No Market.”

In a paper recently published by the Indian government on Circular Economy in Toxic and Hazardous Industrial Waste, CMSR was mentioned as one of the main focuses to enhance India’s chemical management. The report acknowledges the need to implement the CMS Rules and also highlights that India is one of the large chemical economies that is not a signatory to the UN’s GHS (Global Harmonized System of Classification and Labelling of Chemicals). These draft rules envision that change by incorporating GHS in the final draft due later this year (2021).

It also considers that minimizing hazardous waste will regulate and limit the toxic chemicals entering the economic cycle. This emphasises the need for a regulatory framework that promotes and facilitates the circular economy (CE) with compliance and competitiveness of the industry as the core. Lifecycle management of chemicals, extended producer’s responsibility, and precautionary principles are emphasised as necessary tools to address the issue of Hazardous waste and toxic chemicals and also, for the development of an appropriate regulatory framework.

In May 2021, India also published a policy paper on the circular economy in the electronics and electrical sector. These actions show that the government is actively taking steps to change from a linear to a circular economy. As intended, a circular economy path in Toxic and Hazardous Industrial Waste and other vital sectors will bring massive reduction of pollution and congestion. This will also lead to resource efficiency, reduces operating cost, builds competitiveness and self-reliance and most importantly, CE is less damaging to the environment.

In view of the above information, specifically regarding India and the new CMS rules, it becomes imperative that it is necessary to define what circularity and recycling mean in order to recommend an appropriate action plan for implementing a circular economy in toxic and hazardous industrial waste.

 

Date: 2021-07-06

The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of the K-REACH enforcement decree and rule, which was published on June 3rd.

The draft of decree amendment mainly proposes revisions including removing the requirement for polymer submissions to include risk assessment data, designating substance subject to permission, and sharing information with the Office of Customs Administration.

The draft of rule amendment mainly includes submitting feedback on the results of substance hazardous assessments, exemption to data protection request, and data to be submitted when applying for registration of Nano materials.

The deadline of this consultation is July 13, 2021.

Update: 2021-06-28

 

The Government has appointed Graeme Barden as the new Executive Director of the nation’s industrial chemicals assessment and regulatory body, the Australian Industrial Chemicals Introduction Scheme (AICIS).

The regulatory authority has revised various fees and charges, and these changes will take effect from 1 July 2021. There is a slight increase in the registration fees, but the registration charges remain the same (Table 1 below).

The tables below have the revised values in fee structure. 

Table 1: Registration:

Value of industrial chemicals introduced in the previous financial year

2020-2021 fee AU$
 

Fee from 1 July 2021 
AU$

Registration Charge
AU$

Total from 1 July 2021 AU$ (GST does not apply)

Level 1 - $0 to $49,999

72

75

nil

75

Level 2 - $50,000 to $74,999

72

75

75

150

Level 3 - $75,000 to $99,999

72

75

100

175

Level 4 - $100,000 to $249,999

72

75

250

325

Level 5 - $250,000 to $499,999

72

75

500

575

Level 6 - $500,000 to $2,999,999

72

75

3,000

3,075

Level 7 - $3,000,000 to $4,999,999

72

75

5,000

5,075

Level 8 - $5,000,000 or more

72

75

40,000

40,075

 

Table 2: Certificate and Authorisation fees

Fee type

2020-2021 fee AU$

Fee from 1 July 2021 AU$ (GST does not apply)

Certificate applications

Apply for an assessment certificate - very low to low risk

7,599

7,435

Apply for an assessment certificate - health focus / Apply for an assessment certificate - environment focus

23,643

23,375

Apply for an assessment certificate - health and environment focus

34,967

34,965

Apply for an assessment certificate - comparable hazard assessment

17,545

17,515

Apply for an assessment certificate (consolidated application) - an additional chemical that has the same end-use as the first chemical and meets the similarity criteria

5,385

7,015

Apply to vary a term of an assessment certificate

4,743

4,735

Authorisation applications

Application for a Commercial Evaluation Authorisation 

6,280

6,490

Application to vary the terms of an authorisation

2,819

2,525

Listing applications

Apply for an early listing of an industrial chemical on the Inventory

1,499

1,490

Apply to vary a term of an Inventory listing

4,743

4,735

Apply to vary a term of an Inventory listing when an assessment certificate is in force

1,499

1,490

 

Table 3: Protection of confidential business information (CBI)

Fee type

2020-2021 fee AU$

Fee from 1 July 2021 AU$ (GST does not apply)

Apply to protect the chemical name as confidential business information

1,807

1,730

Apply to protect the end-use as confidential business information

554

605

Apply for continued protection of confidential business information

4,587

4,565

Apply to protect information (other than the proper name or end use) as confidential business information

1,063

1,150

 

Table 4: Import and export of certain industrial chemicals subject to international agreements

Fee type

2020-2021 fee AU$

Fee from 1 July 2021 AU$ (GST does not apply)

Apply to export a Rotterdam Convention banned or severely restricted industrial chemical - Category A country (export destination is a Party to the Rotterdam Convention and has given consent in the import response)

1,865

2,395

Apply to export or import a Rotterdam Convention banned or severely restricted industrial chemical - Category B country (export destination is a Party to the Rotterdam Convention and has not provided import response or not given consent in the response)

3,730

4,780

Apply to export a Rotterdam Convention banned or severely restricted industrial chemical - Category C country (export destination country is not a Party to the Rotterdam Convention)

1,865

2,395

 

Table 5: New fee for service activities starting on 1 July 2021

Fee type

Fee AU$ (GST does not apply)
 

Apply to add a certificate holder

1,490

Apply to remove a certificate holder

805

Apply to add a person covered by a certificate

1,490

Apply to remove a person covered by a certificate

805

Apply to add an authorisation holder

1,490

Apply to remove an authorisation holder

805

Apply to be a confidence holder of CBI for a protected Inventory listing

4,100

Apply for an assessment certificate – multicomponent introduction

2,650

The new fee structure will drive manufacturers and importers to be more diligent in determining their introduction values since the Australian chemical regulatory body ‘NICNAS’ four-tier system has been replaced with an eight-tier one (see table 1). This is an effort made by AICIS towards better monitoring and enforcement of post-market chemical activities and regulation.

GPC has a legal entity in Australia and with that, we can help you with your annual declaration submissions. You may contact us at - compliance@au.gpcregulatory.com.

 

Latest update: 2021-06-30

 

 

In EMB Memorandum Circular No. 2021-08, the Department of Environment and Natural Resources (DENR) – Environmental Management Bureau (EMB) issued the 2021 updated Philippine Inventory of Chemicals and Chemical Substances (PICCS). 52 new chemicals were added to the inventory, and this expands the list to 22,277 chemicals.  Pursuant to the provisions of Republic Act No. 6969 and the DENR Administrative Order No. 29 Series of 1992, the legal framework for chemical management took shape. One approach is the inventory of chemicals and chemical substances (PICCS) which was first established in 1995. PICCS is enriched by the information of chemicals’ use provided by importers and manufacturers. It assists the government in monitoring and regulating the importation, manufacture, processing, handling, storage, transportation, sale, distribution, use, and disposal of chemical substances and mixtures that present unreasonable risk or injury to health or the environment.

PICCS is usually updated annually, and so far, DENR has published updated inventories in 2000, 2002, 2005, 2008, 2011, 2013, 2015, 2017, and 2020.

Update: 2021-07-05

 

Philippines-Environmental Management Bureau (EMB) informs the Bureau of Customs (BOC) on the upcoming implementation of GHS in chemical mixtures and seeks their cooperation for enforcement

Early February, the director of The Department of Environment and Natural Resources (DENR) – Environmental Management Bureau (EMB) issued a letter to the Bureau of Customs (BOC) informing them about the implementation of GHS in chemical substances under the Priority Chemicals List (PCL) and Chemical Control Orders (CCOs) as well as the lists of International Air Transport Association (IATA) and International Maritime Dangerous Goods (IMDG). The next scheduled step is to apply GHS to chemical mixtures. The guidelines on implementing GHS Classification and Labelling Requirements for mixtures have been drafted, and it is up for public comments.

In response to the letter from EMB, BOC issued customs memorandum circular no. 78-2021 and directed relevant handling units to strictly enforce the labelling and Safety data sheet (SDS) requirements as specified by the DAO 2015-09. The preparation of labels and SDS is guided by DAO 2015-11.

 

Update: 2021-07-05

Department of Environment (DOE) recently announced its new website for Environmentally Hazardous Substances (EHS) Registration. The platform is for gathering information on EHS identified and notified by importers and manufacturers to DOE. With this information, DOE can monitor the use of EHS and also use the data for risk assessment. The management progress is shared with the public. An example is the list of EHS references made available on the website.

Since 2009, Malaysia has established the Environmentally Hazardous Substances Notification and Registration (EHSNR) scheme. Registration and notification of hazardous substances have been voluntary; however, this is foreseen to become mandatory in the near future.

 

Update: 2021-07-12

On July 9th, ECAH added eight chemicals to the Candidate List of SVHC, expanding the list from 211 to 219 entries. These newly added substances are used in consumer products such as cosmetics, scented articles, rubber, textiles, or as solvents and flame retardants. They are also used for manufacturing plastics products. The Candidate List contains hazardous chemicals that are toxic to human health, specifically in reproduction, carcinogenic, respiratory sensitisers, or endocrine disruptors. Companies may have legal obligations when their substance is included – either on its own, in mixtures or articles – in the Candidate List.

Importers and producers of articles containing a Candidate List substance have to notify ECHA within six months from the date of its inclusion in the list (8th July 2021). Suppliers of substances on the Candidate List also need to provide their customers with a Safety Data Sheet (SDS).

The eight chemical substances are:

#

Substance name

EC number

CAS number

1

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

-

-

2

Orthoboric acid, sodium salt 

237-560-2

13840-56-7

3

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

4

Glutaral

203-856-5

111-30-8

5

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)

-

-

6

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

-

-

7

1,4-dioxane

204-661-8

123-91-1

8

4,4'-(1-methylpropylidene)bisphenol

201-025-1

77-40-7

As of 5th January 2021, suppliers of articles on the EU market containing Candidate List substances in a concentration above 0.1% weight by weight have to notify these articles to ECHA’s SCIP database.

 

 

Update: 2021-07-12

 

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