Chemicals | Summer Recap 2020
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:
Nº |
Substance name |
EC number |
CAS number |
Reason for inclusion |
1 |
1-vinylimidazole |
214-012-0 |
1072-63-5 |
Toxic for reproduction |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
|
April 2020 |
Europe |
EFSA (European Food safety Authority) |
|
May 2020 |
Europe |
EUON (European Union observatory for nanomaterials) |
|
May 2020 |
Europe |
EUON (European Union observatory for nanomaterials) |
|
May 2020 |
Europe |
EFSA (European Food safety Authority) |
|
May 2020 |
Europe |
EFSA (European Food safety Authority) |
|
May 2020 |
Europe |
EUON (European Union observatory for nanomaterials) |
|
June 2020 |
Denmark |
EPA (Environmental Protection Agency) |
|
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) |
|
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) |
|
July 2020 |
Europe |
EUON (European Union observatory for nanomaterials) |
Overview of REACH information requirements and available methods |
September 2020 |
UK |
GOV.UK |
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 PFHxA – webinar 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
- New substance evaluation conclusions published. Substance evaluation - CoRAP
- Committees’ consolidated opinions available on applications for authorisation
- ECHA's completed activities on restriction
- Registry of SVHC intentions until outcome
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:
|
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:
|
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. |
Please see the below table summarising the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):
Countries |
Notification number |
Title |
Europe |
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 |
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 |
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 |
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 |
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 |
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 |
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. |
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:
- Pentabromodiphenyl Ether (PentaBDE) Mixture [DE-71 (Technical Grade)]
- Tris(2-chloroethyl) Phosphate (TCEP)
- Household appliances may expose you to chemicals on the Proposition 65 list such as benzene, carbon monoxide, formaldehyde, and some flame retardants and phthalates
Two new fact sheets on Proposition 65 warnings:
Other relevant news this summer
- Country of Origin Marking of Products of Hong Kong
- Maine Has Designated PFOS and Its Salt as Priority Chemicals. See Chapter 890.
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:
- Proposed amendments to scheduling advice for ACMS #31
- Oxymetazoline
- Eletriptan
- Clotrimazole
- Sildenafil
- Ibuprofen
- Cumyl-pegaclone
- 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.
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 |
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.
|
|
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. |
|
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. |
|
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. |
|
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. |
|
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. |
|
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. |
|
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. |
|
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. |