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Chemicals | Summer Recap 2020

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Regulatory news

 


 

Europe

 

New update of Candidate List of Substances of Very High Concern (SVHCs)

 

On 25th June 2020, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs. With the addition of 4 new substances, the current list of SVHCs contains 209 substances.

 

Below a table outlines the recent substances included:

 

Substance name

EC number

CAS number

Reason for inclusion

1

1-vinylimidazole

214-012-0

1072-63-5

Toxic for reproduction
(Article 57 (c)) 

2

2-methylimidazole

211-765-7

693-98-1

Toxic for reproduction (Article 57 (c))

3

Dibutylbis(pentane-2,4-dionato-O,O')tin

245-152-0

22673-19-4

Toxic for reproduction
(Article 57 (c)) 

4

Butyl 4-hydroxybenzoate

(Butylparaben)

202-318-7

94-26-8

Endocrine disrupting properties - human health

(Article 57(f) – human health)

 

Click here for further information on the ECHA’s website.

 

The chemicals strategy for a toxic-free EU

 

On 9th may 2020, the European Commission published the following initiative:

 

Chemicals – strategy for sustainability (toxic-free EU environment).

 

Its aim is to compile information on chemicals strategy initiatives in order to:

 

  • Reduce the risks associated with chemicals and, inthis way, better protect people and the environment
  • Develop safe and sustainable alternatives
  • Make it even easier to trade safe chemicals within the EU

Further information can be found on the European Commission website here.

 

New webpage on endocrine disrupting chemicals

 

In June 2020, National authorities in Belgium, Denmark, France, the Netherlands and Sweden launched a webpage on endocrine disrupting chemicals. The aim of the website is to compile information on these types of substances and, in this way, to outline their current status in Europe.

 

For further information, please visit the Endocrine Disruptor Lists website here.

 

Recent publications by European Commission

 

The below table summarises recent publications by the Official Journal of the European Union:

 

Date

Reference

Title

07-04-2020

2020 / C 115/04

Notice to companies intending to import or export, in 2021, controlled ozone-depleting substances to or from the European Union, and to companies intending to produce or to import such substances in 2021 for essential laboratory and analytical use.

15-06-2020

C/2020/1973

Commission Delegated Regulation (EU) 2020/784 of 8 April 2020 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and Council in relation to  the listing of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds.

24-06-2020

C/2020/3756

Commission Notice Guidelines for the implementation of Regulation (EU) 2019/1148 on the marketing and use of explosives precursors 2020/C 210/01

26-06-2020

C/2020/4003

Commission Regulation (EU) 2020/878 of 18 June 2020 amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

04-08-2020

C/2020/5183

Commission Regulation (EU) 2020/1149 of 3 August 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards diisocyanates

11-08-2020

C/2020/3151

Commission Delegated Regulation (EU) 2020/1182 of 19 May 2020 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

18-08-2020

C/2020/3645

Commission Delegated Regulation (EU) 2020/1204 of 9 June 2020 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the listing of dicofol

 

Technical publications

 

Please find below a table summarising the most recent technical publications on chemical substances (non-exhaustive):

 

Date

Countries

Entity

Title

April 2020

Europe

European Commission

Public Consultation in the context of a Fitness Check of the EU legislation with regard to Endocrine Disruptors: Factual Summary Report.

April 2020

Europe

EFSA (European Food safety Authority)

Assessment of new information on Bisphenol S (BPS) submitted in response to the Decision 1 under REACH Regulation (EC) No 1907/2006.

May 2020

Europe

EUON (European Union observatory for nanomaterials)

NanoApp helps navigate legal obligations under REACH

May 2020

Europe

EUON (European Union observatory for nanomaterials)

A critical review of the factors determining dermal absorption of nanomaterials and available tools for the assessment of dermal absorption.

May 2020

Europe

EFSA (European Food safety Authority)

Safety assessment of the process Veolia URRC used to recycle post‐consumer PET into food contact materials.

May 2020

Europe

EFSA (European Food safety Authority)

Safety assessment of the substance phosphoric acid, mixed esters with 2‐hydroxyethyl methacrylate, for use in food contact materials.

May 2020

Europe

EUON (European Union observatory for nanomaterials)

Are nanomaterials getting under your skin?

June 2020

Denmark

EPA (Environmental Protection Agency)

Survey and risk assessment of slime toys

June 2020

France

ANSES (French Agency for Food, Environmental and Occupational Health & Safety)

Incontinence pads: ANSES publishes the results of its health risk assessment

June 2020

Europe

ECHA (European Chemical Agency)

Bisphenol S has replaced bisphenol A in thermal paper

July 2020

Europe

EUON (European Union observatory for nanomaterials)

New OECD guidance documents for the risk assessment of nanomaterials

July 2020

Europe

EUON (European Union observatory for nanomaterials)

New safety data sheet requirements for nanomaterials

July 2020

Europe

EUON (European Union observatory for nanomaterials)

Overview of REACH information requirements and available methods

September 2020

UK

GOV.UK

Guidance How to comply with REACH chemical regulations

 

Recent updates Regarding REACH

 

The below table showcases a summary of the most recent updates (non-exhaustive) regarding REACH Regulation (EC) No 1907/2006:

 

Summary of the Most Recent Updates

Date

Subject

Link

15-04-2020

Recommended requirements for the active chlorine released from sodium hypochlorite, hydrogen peroxide and peracetic acid.

ECHA publication can be viewed here.

04-05-2020

Extensions to deadlines for industry.

 

The Agency has decided on a number of deadline extensions which applied at the end of May 2020. The companies concerned were informed directly about these extensions at the end of March.

For more information visit the ECHA website here.

13-05-2020

Five European countries (Germany, the Netherlands, Norway, Sweden and Denmark) have launched national calls for evidence in order to compile information about the use of per- and polyfluoroalkyl substances (PFAS) by 31 July 2020.

 

The aim of this call for evidence is to prepare a joint REACH restriction proposal to limit risks to the environment and human health arising from the manufacture and use of a wide range of PFAS.

 

Below you can find the national calls as well as the ECHA publication:

 

View the ECHA news publication here.

13-05-2020

Board of Appeal dismisses appeal against compliance check decision for Pigment Red 112.

For more information visit the ECHA website here.

27-05-2020

Consultation on proposed restriction of PFHxAwebinar Q&A available.

ECHA publication can be viewed here.

27-05-2020

Publication of webinar on PIC regulation. The webinar explains the scope, main requirements notification of exports and the conditions that require explicit consent from importing countries.

For more information visit the ECHA website here.

03-06-2020

The consolidated opinion and proposal from ECHA committees in relation to restricting silicon-based substances (cyclosiloxanes D4, D5 and D6) in consumer and professional productsproposal is available.

For more information visit the ECHA website here.

05-06-2020

20 EU Member States have reported an increase in non-compliant (hand) disinfectants in their markets since March 2020 to the ECHA and European Commission.

For more information visit the ECHA website here.

08-06-2020

Alternatives to animal testing continue to be widely used.

For more information visit the ECHA website here.

10-06-2020

RAC has outlined its opinion on ECHA’s proposal to restrict the use of microplastics in concentrations of more than 0.01 % weight by weight. The ECHA’s Committee for Socio-economic Analysis (SEAC) supports the proposal and, the transition periods it outlinesm and agreed draft opinion on the costs and benefits of this proposal for society. 

For more information visit the ECHA website here.

12-06-2020

REACH REVIEW ACTION 3 (RRA3):

 

Improving the workability and quality of extended Safety Data Sheets (eSDS)

ECHA publication can be viewed here.

16-06-2020

The ECHA’s Member State Committee (MSC) did not agree to identify resorcinol as a substance of very high concern (SVHC) due to its endocrine-disrupting properties. Now, the Commission's REACH Committee will make a final decision.

For more information visit the ECHA website here.

17-06-2020

The Committee for Socio-economic Analysis (SEAC) supported Norway’s proposal to restrict the use of perfluorohexane-1-sulphonic acid (PFHxS) to prevent it from being used as a regrettable substitute for another 'forever chemical', PFOA, which will be banned from July onwards.

For more information visit the ECHA website here.

17-06-2020

New intention to identify a substance of very high concern:

 

For more information visit Registry of SVHC intentions until outcome in ECHA’s website.

18-06-2020

By 2022, BPA is expected to be replaced mainly by BPS in thermal paper.

 

ECHA has published a report:

 

The use of bisphenol A and its alternatives in thermal paper in the EU during 2014 - 2022

ECHA publication can be viewed here.

24-06-2020

The study commissioned by ECHA and the European Commission on PFAS-based fire-fighting foams collecting information for potential regulatory action is available.

The report can be viewed here.

01-07-2020

EU inspectors to check consumer products for hazardous substances.

 

The Enforcement Forum agreed that its major enforcement project planned for 2022 (REF-10) will focus on integrated checks of products that control several duties from different pieces of legislation – mostly related to articles, but also to mixtures. Most of the products are expected to be consumer products.

ECHA publication can be viewed here.

02-07-2020

How will the UK withdrawal affect you?

ECHA publication can be viewed here.

07-07-2020

Restriction of four phthalates DEHP, DBP, DIBP and BBP are now applicable.

ECHA publication can be viewed here.

08-07-2020

Restriction and authorisation found to drive replacement of harmful chemicals.

ECHA publication can be viewed here.

16-07-2020

PFHxA restriction proposal: updated indicative list of substances.

ECHA publication can be viewed here.

22-07-2020

22 hazardous chemicals added to EU regulation on imports and exports.

ECHA publication can be viewed here.

18-08-2020

New Board of Appeal decisions concerning vertebrate animal testing on cosmetic ingredients.

ECHA publication can be viewed here.

31-08-2020

Notifications from EU companies to export certain hazardous chemicals outside the Union have continued to steadily rise over the last three years. More than 10 000 notifications were processed in 2019 – an increase of around 35 % compared to 2016. With the increased workload, adequate resourcing is a necessity for future PIC work.

ECHA publication can be viewed here.

 

Other interesting links about REACH

 

 

Recent Updates Regarding CLP

 

The below table includes a summary of the most recent updates (non-exhaustive) regarding CLP Regulation (EC) No 1272/2008:

 

Summary of the Most Recent Update

Date

Subject

Link

06-05-2020

A new customised way to prepare your poison centre notifications through the IUCLID and ECHA Submission portal.

For more information visit the Poison centres website here.

12-05-2020

The European Commission has launched a consultation in relation to the updated requirements for submitting information to poison centres.

 

Deadline for comments was 9 June 2020.

For more information in European commission website here.

12-05-2020

The European Commission has launched a consultation on the introduction of specific labelling information for paints created specially in-store (bespoke paints – as opposed to off-the-shelf ones).

 

Deadline for comments was 9 June 2020.

For more information in European commission website here.

12-05-2020

New submission test environment to prevent misleading data reaching Member States.

For more information in Poison centres website here.

20-05-2020

Updated guidance clarifies labelling requirements for poison centre notifications.

For more information in Poison centres website here.

 

Other interesting links about CLP

 

 

Updates Regarding Poison Centre

 

The below table includes a summary of the most recent updates (non-exhaustive) regarding Poison Centre:

 

Summary of the Most Recent Update

Date

Subject

Link

05-05-2020

The new release of IUCLID now has a customised view which allows users to see only those fields that are relevant to poison centre notifications in the dataset mode.

For more information visit the Poison Centre website here.

19-05-2020

The following guidances have been updated:

 

  • Guidance on harmonised information relating to emergency health response – Annex VIII to CLP – has been updated (version 3.0) which entered came  into force on 20 January 2020.
  • Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008( version 4.1)

For more information visit the Poison Centre website here.

19-05-2020

A new test environment is available for companies marking submissions through the ECHA Submission portal and for those using the system-to-system service.

For more information visit the Poison Centre website here.

04-06-2020

Safer Chemicals Conference.

 

The presentations are available on the event page, including information on the latest developments to the PCN IT solution, how instructions as to how to apply UFI code in labelling, industry perspective on notification tools and a demo on how to prepare a poison centre notification.

For more information visit the Poison Centre website here.

11-06-2020

Tips for successful poison centre notifications.

For more information visit the Poison Centre website here.

13-06-2020

Updated IT tools for poison centre notifications.

 

The next major update of IUCLID will take place in October 2020 and will cover an updated Poison Centre Notification (PCN) format.

For more information visit the Poison Centre website here.

22-06-2020

Lithuania, Denmark, Germany , Estonia, Slovenia and Poland are now the European countries that accept poison centre notification through EHCA’s submission portal.

For more information, visit the Poison Centre website here and here.

22-06-2020

The following  publications now available in 23 EU languages:

 

  • The UFI and what it means for your product labels  [PDF] [EN]
  • Information requirements for poison centres notifications 
  • How to prepare and submit information to poison centres [PDF] [EN]

For more information, visit the Poison Centre website here.

20-07-2020

Changes in product categorisation for notifying poison centres.

For more information, visit the Poison Centre website here.

02-09-2020

Practical solutions to help meet harmonised information requirements.

For more information, visit the Poison Centre website here.

 

Regulatory updates

 

Please see the below table summarising the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

 

Countries

Notification number

Title

Europe

G/TBT/N/EU/725

Draft Commission Delegated Directive amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of certain lead and hexavalent chromium compounds in electric and electronic initiators of explosives for civil (professional) use.

Europe

G/TBT/N/EU/726

Draft Commission Delegated Directive amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards the validity period of an exemption for the use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems.

Europe

G/TBT/N/EU/729

Draft Commission Delegated Regulation amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.

Europe

G/TBT/N/EU/731

Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and related substances.

 

Please find below a table summarising recent regulatory proposals made to the European Commission (Non-exhaustive):

 

Countries

Notification number

Title

Finland

2020/306/FIN

Draft Government Bill amending the Waste Act and certain other acts.

 

In the draft Government Bill, distance sellers, and other parties equivalent to a producer, established in countries other in Finland would be, in line with the amendments to § 46 and 48 of the Waste Act (646/2011), brought more clearly within the scope of application of producer responsibility and relevant obligations.

Italy

 2020/340/I

Pursuant to Article 184b, paragraph 2 of Legislative Decree No 152 of 3 April 2006.

 

The draft regulation identifies the criteria under which paper and cardboard waste, following specific processing and provided that it meets the requirements established in the regulation, can no longer be classified as waste to be reintroduced into the economic cycle as products.

Sweden

2020/373/S

Act (2016:1067) concerning tax levied on chemicals in certain electronic items.

 

The proposal means that the seller is liable to pay tax for sales to consumers where goods are transported to Sweden from another EU country by the seller or someone else on behalf of the seller if the seller’s annual sales of taxable goods exceed a threshold of SEK 100,000. In cases where the seller does not become liable for tax, but the sales are mediated by another operator, the intermediary becomes liable for tax if the annual value of the intermediary exceeds the threshold.

 

US

 

Maryland passes flame retardant ban

 

Recently, the state of Maryland passed SB 447 without governor’s signature, banning the import or sale of juvenile products, mattresses, upholstered furniture, or reupholstered furniture that contains more than 0.1% of flame retardant chemicals with some exceptions.

 

Flame retardant is defined as a chemical used to inhibit the spread of fire, or that acts as a synergist to a chemical that inhibit the spread of fire, and:

 

  • Contains one or more halogen elements, including fluorine, chlorine, bromine or iodine
  • Contains one or more carbon elements and one or more phosphorus or nitrogen elements; or is a nanoscale chemical

This act will come into effect on 1 January 2021. The Department of Health is required to adopt certain regulations in order to carry out this act by 1 June 2021.

 

For more information, please click here.

 

New York amends lead-containing jewellery law

 

On April 17, 2020, the New York governor signed Assembly Bill A08978 into law to amend labelling requirements of certain jewellery containing lead which will be effective as of 1st January 2021.

 

In comparison to the Lead-Containing Jewellery Law (A6041/S4046) passed last December, this new signed law covers the following main amendments:

 

  • Lowering the threshold of ‘less than 600 ppm lead content’ to ‘less than 100 ppm lead content’ as part of the criteria for a warning statement
  • Deleting” COMPLIES WITH FEDERAL STANDARDS” content in the warning statement

The effective date for warning statement requirements is unchanged and remains January 1, 2021 under this new act.

 

For more information, please click here.

 

Proposition 65: new fact sheets

 

See below a list of new fact sheets available in the Proposition 65 website.

 

Three new fact sheets on Proposition 65-listed chemicals have been added:

 

Two new fact sheets on Proposition 65 warnings:

 

 

Other relevant news this summer

 

 

Australia

 

Public consultation on isothiazolinones

 

In April 2020, Australia’s Department of Health initiated a consultation on ten proposed amendments to the existing Poisons Standard. The proposed amendments are:

 

  1. Proposed amendments to scheduling advice for ACMS #31
  • Oxymetazoline
  • Eletriptan
  • Clotrimazole
  • Sildenafil
  • Ibuprofen
  • Cumyl-pegaclone
  1. Proposed amendments to scheduling advice for the Joint ACMS-ACCS #25
  • Nicotine
  • Cannabidiol
  • Methylisothiazolinone and methylchloroisothiazolinone
  • Isothiazolinones

On 18th May 2020, the public consultation in relation to proposed amendments to the Poisons Standard closed. All public submissions have been published on the TGA website.

 

For more information, please visit the TGA website here.

 

New era in regulation of industrial chemical importation and manufacturing

 

From 1st July 2020, AICIS (Australian Industrial Chemicals Introduction Scheme) is the new national regulator of industrial chemical introduction. The scope of the scheme covers chemicals, polymers and ingredients of products used in printing, plastics, mining, construction, paints, adhesives, consumer goods, cosmetics and many more.

 

An overview of the changeover and a full explanation of the transitional arrangement for the changeover from NICNAS to AICIS are available here.

 

For further information on AICIS, please visit AICIS’s website here.

 

International

 

Regulatory proposals notified to WTO

 

Please see the below table summarising the most recent notifications made to the World Trade Organization (non-exhaustive):

 

Notification number / Link

Country

Title

G/TBT/N/EU/714

Europe

Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants.



This draft Commission Regulation aims to:

 

  • Delete three entries from Annex XVII to the REACH Regulation, as the substances concerned have been, or are about to be, incorporated into Regulation 2019/2012 on persistent organic pollutants
  • Include an exemption, from the aforementioned entries 28 to 30, for devices covered by Regulation (EU) 2017/745 on medical devices
  • Delete an obsolete paragraph mandating a review of the restriction on liquid substances or mixtures
  • Delete obsolete references to "R phrases" from the restriction on liquid substances or mixtures
  • Delete obsolete references to CMR classifications under Directive 67/548 from the titles of Appendixes 1-6 of Annex XVII
  • Update the references to testing methods for azocolourants in Appendix 10 of Annex XVII, to reflect technical progress
  • And finally delete the CAS and EC numbers from entry 46 of Annex XVII, as their inclusion, in 2009, inadvertently reduced the scope of this entry, and the original intention of the legislator should be reflected again

G/TBT/N/EU/719

Europe

Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures in order to improve the workability of information requirements related to emergency health response accompanied by an Annex.

 

According to Article 45(1) of the CLP Regulation, EU Member States' appointed bodies shall be responsible for receiving information from importers and downstream users on the hazardous chemical mixtures they place on the market.

G/TBT/N/EU/720

Europe

Draft Commission Delegated Regulation amending Article 25 of Regulation (EC) 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards bespoke paints.

 

According to Article 45(1) of the CLP Regulation, EU Member States' appointed bodies shall be responsible for receiving information from importers and downstream users on the hazardous chemical mixtures they place on the market.

G/TBT/N/USA/1595

US

Modification of Significant New Uses of Certain Chemical Substances.

 

EPA’s proposed rule - This action would amend the SNURs to allow certain new uses reported in the SNUNs without additional notification requirements and modify the significant new use notification requirements based on the actions and determinations for the SNUN submissions. EPA is proposing this amendment based on review of new and existing data on chemical substances.

G/TBT/N/USA/1599

US

TSCA Chemical Data Reporting Revisions Under TSCA Section 8(a).

 

EPA’s final rule - The CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every four years. EPA is finalising several changes to the CDR rule to implement regulatory updates that align with new statutory requirements of TSCA, to improve the CDR data collected as necessary to support the implementation of TSCA, and potentially to reduce burden on certain CDR reporters. In addition, these regulatory modifications may result in additional information to be supplied to the EPA and the public that is currently not collected; improve the usability and reliability of the reported data; and ensure that data is available in a timely manner.

G/TBT/N/USA/1611

US

Significant New Use Rules on Certain Chemical Substances (20-4.B).

 

EPA’s proposed rule - This action would require persons to notify the EPA at least 90 calendar days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by this proposed rule. This action would further require that persons not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice, and EPA has conducted a review of the notice, made an appropriate determination on the notice under TSCA, and has taken any risk management actions as required as a result of that determination.

G/TBT/N/USA/1616

US

Significant New Use Rules on Certain Chemical Substances (20-1.5e).

 

EPA’s proposed rule - The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify the EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as required by that determination.

G/TBT/N/USA/1617

US

Draft Scopes of the Risk Evaluations To Be Conducted for Seven Chemical Substances Under the Toxic Substances Control Act.

 

EPA’s notice - The draft scope document for each chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations the EPA plans to consider when conducting the risk evaluation for that chemical substance. The EPA is also opening a 45-calendar day comment period on these draft scope documents to allow the public to provide additional data or information that could be useful to the Agency in finalising the scope of the risk evaluations; comments may be submitted to this docket and the individual dockets for each of the chemical substances.

G/TBT/N/USA/1618

US

Draft Scopes of the Risk Evaluations To Be Conducted for Thirteen Chemical Substances Under the Toxic Substances Control Act.

 

Notice - The draft scope document for each chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations the EPA plans to consider when conducting the risk evaluation for that chemical substance. The EPA is also opening a 45-calendar day comment period on these draft scope documents to allow the public to provide additional data or information that could be useful to the Agency in finalising the scope of the risk evaluations; comments may be submitted to this docket and the individual dockets for each of the chemical substances.