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Intro -





 
Make sure your Safety Data Sheets (SDS) are in the new format as of 2023 and see if you have HazCom (and takeback) obligations if you are selling online. We keep an eye on the new hazard classes proposed under the upcoming CLP amendments – let’s see how they might affect your business! We've also expanded our HazCom team to meet the growing service demand.
Europe -

 
North America -






 
TSCA progress report and U.S. EPA's move on New Chemicals Program.

California intends to review Section 27000 List of substances for further testing, possibly list bisphenol A (BPA) as a carcinogen and Antimony as known to cause cancer under Prop 65. Far-reaching court ruling on Prop 65 warnings and exposure to chemicals
Rest of World -

 
H2 Compliance news -

 
Meet our expanded Hazard Communication team
We sponsor the Irish Pharma Awards and share highlights from recent conferences.
Landbell Group News -
Takeback solutions for online sellers
Green Alley Award 2023 applications still open! 

Remember to update to the new SDS format by start of 2023

The requirements for SDS are changing for the EU market – and SDS should conform with the new standard as of 1 January 2023. Amended Annex II of REACH describes what information should be included in each of the 16 sections of the SDS (Regulation (EU) 2020/878).
 
The changes, with both major and minor impact on SDS content, include expanded information required on:
  • nanoforms (section 1)
  • endocrine disrupting properties (sections 2, 3, 11 and 12)
  • physical and chemical properties (section 9), and  
  • transportation (section 14)
Specific concentration limit, acute toxicity estimate (ATE) and M-factor should now be included (section 3), as well as lower concentration limits for certain substances, for example those classified as respiratory sensitizers and skin sensitizers.
 
With just two months of the transition period remaining, now is the last chance to review and update your SDSs. Meet our HazCom team and get in contact for help.

New hazard classes to be introduced by the CLP amendment

The European Commission is moving ahead with amending the Regulation (EC) 1272/2008 as regards hazard classes and criteria for the classification, labelling & packaging of substances and mixtures. These new hazard classes (and corresponding new sections) are proposed in the draft:
  • 3.11. Endocrine disrupting property for human health
  • 4.2. Endocrine disrupting property for the environment
  • 4.3. Persistent, Bioaccumulative and Toxic (PBT) or Very Persistent, Very Bioaccumulative (vPvB) properties
  • 4.4. Persistent, Mobile and Toxic (PMT) or Very Persistent, Very Mobile (vPvM) properties
In its preamble to the proposed delegated act, the Commission states the need to adapt to the technical and scientific progress by introducing new hazard classes and criteria. It refers to the experience and increased scientific knowledge gained in identifying substances of very high concern (SVHC) due to their endocrine disrupting properties as well as in identifying substances as PBT, vPvB, PMT and vPvM under the REACH Regulation.
 
The draft delegated act proposes a deferred application date for the new hazard classes to ensure that suppliers of substances and mixtures have time to adapt to the new classification and labelling provisions. It is foreseen that substances and mixtures placed on the market before the end of that deferral period would be allowed to continue being placed on the market without re-classification and re-labelling, to avoid additional burden on suppliers.
 
Following the consultation in October, the timeline for the Commission’s adoption is not currently specified. Draft legal texts and public comments are available here.

Online sellers have HazCom obligations as well

Online sale of products, often cross-border and via intermediary marketplace platforms, is widespread and particularly challenging in terms of compliance. Last year’s EU-wide enforcement project on online sales revealed a significant degree of non-compliance in products sold online.
 
For products sold online, any legally required warnings, information and labels should be indicated on the website and be clearly visible in their entirety before the customer makes their purchase.
 
Moreover, the language of the hazard information should meet the requirements of the destination market. Sellers frequently rely on labels and SDS generated by non-EU suppliers making compliance more challenging for EU retailers.
 
The non-compliance rates of ‘online marketplaces’ – the e-commerce platforms acting as intermediaries for various sellers – are much higher compared to ‘web-shops’ where products are sold directly by the suppliers who are responsible for their inventories’ compliance. An additional difficulty is caused by the role of fulfilment houses (FH) – logistics hubs that are not ‘in charge’ of the inventory and its compliance.
 
Regulations will place more chemical compliance responsibilities on marketplaces and FHs, particularly if a non-EU exporter of chemical products does not have a presence in the EU. They may incur the obligations of the supplier (SDS provision, labelling), as well as the importer (registration, classification). Besides, the FHs in the EU need to take occupational safety measures to protect their employees, including appropriate safe use information for the products they are handling. 
 
H2 Compliance is familiar with the unique challenges and growing pressures on online marketplaces, FHs, online retailers, and suppliers with a dispersed global customer base through internet sales. Please get in touch to discuss your needs and for support navigating this evolving compliance field.

Also see how our colleagues at Circular Economy Engineering team are supporting distance sellers with takeback obligations in Europe and North America.

EU environmental law – implementation review 2022 

The European Commission published its 3rd Environmental Implementation Review (EIR) – a regular reporting and collaboration mechanism designed to improve the implementation of EU environmental laws and policies. The 2022 EIR reports on the progress of 27 countries in complying with key environmental obligations, and includes a policy paper (Communication from the Commission) identifying the common challenges and priority actions for all countries.

Two sections that will be of interest to our customers are:
  • 3.1. Circular economy and waste management, and
  • 3.3. Towards zero pollution featuring a dedicated section on Chemicals.
On chemicals, EIR notes that enforcement of REACH and CLP has improved as compared to 2010-2012. The recorded compliance levels appear to be stable over time, while the enforcement authorities seem to be more effective in detecting non-compliant products/companies. However, coordinated enforcement projects have shown that enforcement can be further improved. Thus, the Commission is exploring the feasibility of establishing a European Auditing Capacity to ensure more homogeneity in enforcement between the Member States.
 
On inspections’ outcomes, EIR indicates that around 70% of REACH controls lead to enforcement measures – most frequently a written advice (11%), followed by administrative measures (4%) and verbal advice (2%). When sanctions are applied, they usually consist of a fine, and to a lesser extent referral to the prosecutor’s office for violation of REACH & CLP. Suspension or revocation of business licences has rarely been used. The situation varies greatly between countries. For instance, nearly three quarters of referrals to the state prosecutor’s office for breaches of REACH were reported by just two Member States (Germany and Sweden).

US Federal-level EPA Updates

TSCA progress report by American Chemistry Council (ACC)

The ACC recently released a progress report on the current state of TSCA implementation within the US. The report highlights some of the challenges and suggests possible solutions for the EPA to consider in order to improve implementation moving forward.

Some of the main TSCA concerns that the ACC indicates include a continued lack of clarity around the “whole chemical” approach, mischaracterizing worker safety by adhering to a No-PPE assumption, failing to consider realistic and applicable uses and exposures, a delay in review of new chemicals, and an increase in fees. The ACC will continue to promote solutions to the EPA in order to improve TSCA implementation.
New Effort to Bring New Chemicals Used in Electric Vehicles, Semiconductors, and Clean Energy Sectors to Market

Last month, the EPA released a decision to improve and streamline processes under TSCA’s New Chemicals Program for new chemicals being used in batteries, electric vehicles, semiconductors, and renewable energy generation.

This new process applies to mixed metal oxides (MMOs) which includes new and modified cathode active materials (CAMs). While these chemicals will still be subject to Premanufacture Notices (PMN) under TSCA, the EPA will be providing training for those interested in the new streamlined approach to reviewing the MMOs.

US State-level Regulatory Updates - California

California’s Office of Environmental Health Hazard Assessment (OEHHA) announced its agendas for the upcoming Developmental and Reproductive Toxicant Identification Committee (DARTIC) and Carcinogen Identification Committee (CIC) meetings, which will take place before the end of the year.
 
Section 27000 List Review

We previously reported on DARTIC’s agenda, which will also include review of a recent report on Title 27, Section 27000 for the chemicals to be tested for a further understanding of their carcinogenic or reproductive toxicity potential. The Section 27000 list has no regulatory impact and does not require any testing be done, but rather provides a source of information concerning chemicals that need further testing pursuant to state or federal law. It is essentially a resource list which keeps track of substances that may be targeted for further toxicity testing to better understand their toxicity profile.

Both DARTIC and CIC will be reviewing recent changes to the list, which were made in consultation with the California Department of Pesticide Regulation (DPR) and the US EPA Office of Pollution Prevention and Toxics (OPPT) and Office of Pesticide Programs (OPP).
 
Possible Prop 65 listing of bisphenol A (BPA) as a carcinogen

The CIC meeting announcement outlined their intent to review the possible Prop 65 listing of bisphenol A (BPA) as a carcinogen and opened a 45-day comment period on the hazard identification document published in tandem with the announcement. The document provides extensive detail as to OEHHA’s approach to a systematic literature review and assessment of the carcinogenic potential of BPA. The review and assessment were undertaken after BPA was placed on CIC’s “high priority” list for future Prop 65 listing consideration in 2020.

Notably, no other government agency has evaluated or classified BPA as a potential carcinogen. BPA is mostly commonly used in polycarbonate plastics and epoxy resins. Humans are commonly exposed through food and drinking water. BPA is already listed as a developmental toxicant following a series of court cases during which is was delisted for reproductive toxicity, then listed only pertaining to female reproductive toxicity, and then finally resolved and reinstated as a developmental toxicant in 2020. The current maximum allowable dose level (MADL) for BPA is 3 µg/day. Depending upon the CIC decision whether to list BPA, additional regulatory announcements can be expected for a potential no-significant risk level (NSRL) for BPA.

The meeting will take place on December 14, 2022
 
OEHHA’s Intent to List Antimony (Trivalent Compounds)

In late September, OEHHA notified of its intent to list antimony (trivalent compounds) as known to the state to cause cancer under Prop 65. The action was undertaken via the Labor Code listing mechanism. This mechanism allows OEHHA to list substances pursuant to actions by other agencies, such as IARC. IARC has previously classified antimony (trivalent compounds) as a Group 2A carcinogen, or “probably carcinogenic to humans”. This was based on limited human evidence, but sufficient evidence of carcinogenicity in animals and “strong mechanistic evidence” in human in vitro tests. After the intent commenting deadline of October 31, 2022, the revisions may be made to the listing based on available comments and evidence.
 
California Appellate Court Decision Limits Scope of Warning Requirements

In a recent ruling by California’s First Appellate District Court, they found that Prop 65 warnings are only required for “direct exposure” to a listed compound. The court case involved Prop 65 enforcement allegations by Environmental Health Advocates (EHA) against Sream, Inc., a water pipe product manufacturer. Specifically, EHA alleged that Sream had violated Prop 65 by not providing a written warning on their water pipe products that the pipes exposed consumers to marijuana smoke. The initial trial court granted summary judgment in favor of Sream, provided that the water pipes do not require marijuana to function and therefore marijuana is not a given exposure scenario upon use of the water pipes, but an appeal was filed by EHA and further arguments were heard by the First Appellate District Court. The appellate court evaluated whether Sream’s water pipe products actually exposed consumers to marijuana smoke within the meaning of Section 25249.6 of Prop 65, which states that “[n]o person in the course of doing business shall knowingly and intentionally expose any individual to chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual”. In its decision, the appellate court cited a 1988 definition of exposure by the California Health and Welfare Agency, which stated that Prop 65 “prohibit[s] any act that directly brings a consumer into contact with a listed chemical”. The appellate court further opined that providing warnings for direct exposure to a Prop 65 listed chemical “allows consumers to make... informed choices,” and that “[r]equiring a warning for possible indirect contact, depending on how a consumer chooses to use the product, would introduce confusion into that decision-making process”. They therefore ruled in favor of Sream.
 
The appellate court’s written opinion will have far-reaching effects on the enforcement of Prop 65 warnings by limiting the scope of such warnings to only direct exposures. In the age in which enforcement allegations have precipitated the need for detailed warning guidance from OEHHA and additional court cases surrounding the potential for exposure based on how a product is used (I.e., warnings for potential exposure to arcylamide in cooked foods), this opinion will likely reduce the number of enforcement allegations in the future.

Turkey – Ministry to publish circular to assist KKDIK registrants

The Ministry of Environment, Urbanisation and Climate Change (MoEUCC) in Turkey is currently preparing new measures to help KKDIK registrants submit dossiers ahead of the deadline in December 2023. Concern has been raised regarding the exceptionally low number of registrations and the problems with access to data.
 
This was announced at a recent meeting between the Ministry and industry representatives. The Ministry is shortly publishing a circular with new guidance on data sharing, potentially including a cap on costs and a delay for certain information requirements.
 
To date, the Ministry has only received approximately 504 lead dossiers, which is significantly lower than expected. Industry is expecting over 10,000 registrations.
 
The final deadline of the 31 December 2023 is not expected to be postponed. Tonnage band-specific deadlines (before 31 December 2023) for Lead Dossiers per tonnage band will be announced with the circular. This means that the Ministry could impose some dates during 2023 for the submittal of the lead registrations, probably based on tonnage band criteria. If no Lead Registration has been defined by that specific deadline the MoEUCC will assign a company from the MBDF (similar to SIEF in EU) to the role.
 
H2 Compliance will provide an update once the circular is published.

Eurasian Union's regional regulation is further delayed 

The expected adoption of the Russia-dominated Eurasian Economic Union's (EAEU) chemicals management regime - technical regulation TR EAEU 041/2017 - is further delayed, potentially to 30 December 2023. The general situation in the region remains volatile. 

The competent authorities of the EAEU member states (Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia) did not complete their national chemicals inventory lists and submit them to the Eurasian Economic Commission (EEC) by the deadline of 1 September 2022.  Consequently, EAEU failed to meet its 1 October 2022 deadline for finalising a central regional inventory of chemicals for the five member states.

The technical regulation originally planned for 1 July 2021 had been previously postponed to 30 November 2022. At the time, industry raised concerns over potential disclosure of confidential business information and timely preparedness for the future notification and registration requirements. The proposed regulation would also make GHS labels and safety data sheets compulsory for the chemical products on the EAEU market.

Welcome to two SDS authors - Natalia and Marzena!

Natalia Kaczorowska joined the H2 Compliance Chemical team in June 2022.

She has a master’s degree in Chemistry with a particular focus in Analytical Chemistry.

Natalia is an SDS author with several years of experience in regulatory consulting for industry. Her skills will support hazard communication activities.
Marzena Pysz joined H2 Compliance team in July 2022 as an experienced SDS author with several years of regulatory knowledge.

Marzena has a master’s degree in Industrial and Engineering Chemistry and completed postgraduate studies in Safety in Use and Management of Chemicals.

Marzena is REACH, CLP and PCN specialist who supports customers in the legislation of products placed on the market.

Highlighting our HazCom / SDS Services Team 

Paweł Jędrzejczyk is with H2 Compliance since 2017 and is now a Hazard Communication Service Manager.
Paweł has a master’s degree in Chemistry with a particular focus in Physical Chemistry. Paweł also have a postgraduate diploma in Safety in use and management of chemicals. Paweł is an SDS author, PCN expert, DGSA advisor and regulatory consultant with years of experience in Chemical Legislation area.
 
Ewelina Strzelecka-Szewc joined the H2 Compliance Chemical team in September 2020 as an experienced SDS author, with several years of regulatory and EHS knowledge. Ewelina has a master’s degree in Biology and completed postgraduate studies in EHS.
Her skills and deep understanding of chemical industry are always beneficial to our customers and help them bridge the gap between the regulatory requirements and business needs.
 
Joanna Pojawa became a part of H2 Compliance team in November 2021 as a Chemical Regulatory Consultant. Joanna graduated from the Faculty of Chemistry and her undergraduate focus was in Environment Protection.
She has experience in biocides registration having worked in The Office for Registration of Medical Products, Medical Devices and Biocidal Products.  
H2 Compliance SDS, GHS, CLP, HazCom Services

H2 attended the recent Chemical Watch Regulatory Summits – several key themes emerged

H2 Compliance attended the recent Chemical Watch Regulatory Summits held in Brussels, Belgium, and Arlington, Virginia, US. The summits covered a wide array of global regulatory developments in the EU, Asia, Turkey, Canada, South America, and the US. While several themes emerged from the conference speakers, many highlighted the simultaneous changes in chemical control regulations worldwide which require active surveillance and vigilance when it comes to compliance.
 
In particular, several talks focused on the proposed changes to EU REACH based on the Chemicals Strategy for Sustainability (CSS) and reflection on ECHA's and European Commission's (EC) progress to date. While a lot appears to be happening at one time, the EC is calling the changes an evolution and not a revolution, noting that existing processes will remain the basis for regulating chemicals in the EU. Despite the rhetoric, it is still an unsettling time for industry until more clear and transparent guidance for these regulatory changes is provided.

Perhaps, the forthcoming change that is most highly scrutinized includes the definition of essential use. Many argue that the current criteria are too simplistic and unclear, and specifically that it is unclear whether essentiality applies only at a substance level or a product level. Several at the conferences reiterated the need for a clearer, complete, and transparent consultation process as it will have an important and fundamental effect on EU industry.
 
While the EC has yet to publish their proposal (which may be delayed to late 2023) to revise REACH in line with its CSS, the following items will be evaluated: 

  • Update registration requirements – increased information requirements, polymer registration and information on environmental footprint
  • Introduce Mixtures Assessment Factor (MAF)
  • Improve safety data sheets
  • Revise dossier and substance evaluation
  • Reform authorization and restriction processes
  • Improve enforcement.

In addition to EU updates, the US regulatory summit highlighted the need for greater transparency and guidance from the US EPA as part of their New Chemicals Program and risk evaluation process under TSCA. Furthermore, Michal Freedhoff, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention at EPA, reiterated this EPA administration’s commitment to more efficient processes in order to bring chemicals to market in a way that is innovative, safe and efficient.
 
H2 Compliance is here to help companies navigate the complex and ever-changing landscape of chemical control regulations.

H2 Compliance sponsors the 2022 Irish Pharma Awards

H2 Compliance is delighted once again to be supporting the Irish Pharmaceutical Industry and celebrating its own involvement in this key industry in Ireland.

We are sponsoring the Pharma Supplier of the Year award. There are seven worthy shortlisted companies in this category - we wish them the very best of luck and look forward to meeting them face to face at the awards ceremony next week:
          - Ardmac                       - CBRE Global Workplace Solutions
          - Hanley Calibration      - LotusWorks
          - Micro-Bio Ireland        - NCC
          - WD Excellence

The winners will be announced at the gala awards on November 10, in Dublin. The ceremony will offer a live in-person event as well as a broadcast for those who wish to support the awards remotely.

Supporting distance sellers with takeback obligations in Europe and North America

Extended producer responsibility (EPR) is expanding and one of its obligations is takeback from end-users - to recycle or refurbish end-of-life items. This applies to the online sales as well. Distance sellers must provide takeback on a 1-to-1 (one new purchase for one return) or 0-to-1 (no purchase for one return) basis.  

The current priority is waste electrical and electronic equipment (WEEE) and batteries. However, the focus is turning to other EPR streams, such as DIY equipment, furniture, and chemicals.

The Circular Economy Engineering team at H2 Compliance is responding to the growing challenge! The team already has a solution in place to accommodate takeback requests from any type of customer (small to large), business type, and sector – and it is currently delivering these services in Europe and North America. 

Since the beginning of the takeback program in 2020, the team has collected more than 15,000 end-of-life devices – the equivalent of around 400 tons of WEEE – in 20 different countries. 

The takeback solution is centralized and completely online and H2 Compliance also provides reporting services to authorities. For more information, please contact the team here

Green Alley Award 2023 - apply by 21 November

The Green Alley Award is Europe’s first startup prize specifically for the circular economy, distinguishing Europe's best startup innovators working on a sustainable future!

If your company is a startup invested to further environmental goals or you know of such startups with a positive mindset, integrity, courage, and drive - welcome to apply and get a chance of winning 25,000 € with the sustainable business ideas. Share the word with your startup friends and business partners and help us reach startups all over Europe!
 
Application accepted till 21 November 2022: https://green-alley-award.com/apply/

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