An Inception impact assessment has been published by the European Commission, with a full impact assessment of the revision to follow.
The updates will include changing the scope of the regulation to address environmental endpoints, such as a ban on persistent, bioaccumulative and toxic (PBT) chemicals, ban on endocrine disrupters, potential ban on immunotoxic and neurotoxic chemicals and those toxic to specific organs; and extending generic risk management to ingredients in consumer products. A review of the Regulation’s definition of nanomaterials is also due by the end of the year.
There is also an intent to move the work of the European Commission’s Scientific Committee on Consumer Safety (SCCS), currently in charge of risk assessment of the substances used in cosmetic products, to an EU Agency. This would align with the ‘One substance, One assessment’ approach and make safety assessments across various EU legislations more coherent and efficient. The options for such a reorganisation are still to be examined.
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Congratulations to those eligible to submit DUINs and who were able to do so before the deadline!
At H2, we have had a flurry of activity this past week with both new and existing clients looking to secure some last-minute business continuity in the UK. We helped over 40 Only Representative (OR) clients and a number of UK-based importers analyse their portfolios, work out which substances could benefit from the DUIN provisions, and successfully submit their notifications so that they can continue importing into the UK without needing a full registration (for the time being).
All of the early UK REACH transitional deadlines have now passed. Grandfathering is complete; DUIN submission is complete. From now on, grandfathered registrants need to provide the full REACH data to HSE by the relevant deadline, and DUIN notifiers need to submit or be covered by a full registration by those same deadlines (see below). Until those deadlines, manufacture and import can continue unhindered.
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Source: HSE website https://www.hse.gov.uk/reach/duin.htm
Unfortunately, not all substances are eligible for DUIN coverage. For example, anything imported into Great Britain (GB) from outside the EU where an EU-based OR was not appointed. And inevitably, some people will have missed the deadline – what comes next if you are in this situation?
New registration remains the only option to cover manufacture and import into GB. Although now it comes in two flavours: brand new registrations of novel substances (never registered in the EU before), and new registrations of existing substances (“NRES”).
If you want to supply or import substances into GB that were already registered in the EU, then the costs of registration are likely to be lower in the short-to-medium term. HSE expect an inquiry dossier to be submitted (including analytical data), and they will also charge a registration fee for the respective tonnage band. However, they may inform you during the inquiry process that you can submit your registration dossier – including member registration dossier – without having access to the data. HSE request that you include an appropriate data waiver in your dossier and commit to either submitting data, or having access to the relevant data, by the same deadlines above. As such, for low-volume, low-hazard substances, where you already have a registration dossier, it may be that you can have a registration until October 2027 for under €1500.
This is a relatively low-cost way of securing your supply chains for substances or customers that were not eligible for DUINs, and is the closest one can get to “pre-registration” in the UK. Get in touch with us to see what options are available to you post-DUIN.
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On October 21, the US EPA announced a proposal to once again extend – until 31 October 2024 – the deadline for complying with a TSCA prohibition on the use of the flame retardant PIP (3:1) in articles. PIP (3:1) [phenol, isopropylated phosphate (3:1)] is one of five substance included in the agency’s PBT rules.
Earlier, in January 2021, the EPA had adopted a final rule prohibiting the substance’s use in articles but has twice pushed back the compliance deadline based on the infeasibility of phasing out the widely used substance in such a short period. Even with a 2024 deadline, many industries will either need to speed up their efforts to phase out the substance or make their case to the agency on why additional time is warranted.
Many industries have discovered a wide array of applications where the substance may appear as a flame retardant or plasticizer, including producers of electronics, from cell phones to laptops, appliances, vehicles, and equipment.
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On October 18, the US EPA issued a cross agency roadmap for addressing per- and polyfluoroalkyl substances (PFASs), setting out an agency-wide approach that will impact producers and users of chemicals by imposing new testing and reporting requirements, strengthening the TSCA review of new PFASs and tightening restrictions on the existing ones.
The roadmap presents initiatives to study and control the persistent substance class, including plans to set drinking water limits, further reporting requirements with the addition of more PFASs to the toxics release inventory (TRI) and to categorise PFASs as ‘chemicals of special concern’, a designation that would lower the threshold for supplier notification requirements.
States are also active in this area. In early October, California issued the first State prohibition on the use PFASs in juvenile products sold in the state and joined several other States in banning the use of PFAS in certain food packaging and imposing new chemical disclosure requirements for cookware.
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The Australian Industrial Chemicals Introduction Scheme (AICIS) published its evaluation roadmap for 2024 and beyond, along with a rolling action plan for prioritising chemicals for evaluations. This includes details of its strategic approach, goals and key targets for evaluation and how it intends to achieve them.
The main aim is to ensure that the introduction of chemicals into Australia is supported by contemporary information and recommendations about managing risks associated with its use. They intend to:
- Identify and prioritise industrial chemicals for evaluation
- Produce transparent, targets, risk proportionate and evidence-based evaluations and recommendations to risk managers, and
- Provide high quality information and risk management advice for the safe use of industrial chemicals
The AICIS plan to evaluate at least 20% of chemicals on the inventory for which a current risk assessment is not available, by 2024. This would include inactive chemicals, chemicals unlikely to need further regulation to manage risks and higher concern chemicals. By the end of 2030. They aim to evaluate the remaining unassessed higher concern industrial chemicals on the inventory.
The roadmap includes six actions areas which are critical in achieving its goals. These are as follows:
- Risk reduction which will strengthen the national capacity for industrial chemical risk reduction
- Targeting evaluation and ensuring they are risk-proportionate and transparent.
- Using knowledge and evidence to produce targeted and evidence-based evaluations
- Capacity building by supporting best practice through education and training
- Leadership and engagement by using global chemical intelligence for innovation
- Informing choice through the provision of risk information.
Prioritising chemicals for evaluation will be carried out via the national regulator’s rolling action plan. There is a three-step evaluation selection analysis (ESA) process for identifying candidates for evaluation. These include a high throughout selection of candidates to develop a risk profile by using hazard and exposure information, the application of weighing modifiers to determine relative risk and determination of the overall priority for evaluation based on risks and available data, resources and information.
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H2 Compliance is excited to be a Gold Sponsor of the upcoming Society of Chemical Hazard Communication (SCHC) virtual annual meeting which gives H2 Compliance a booth to showcase our services, have a one-to-one chat, and to deliver a demonstration on “Substance Monitoring - Stewardship Solution to keep you ahead of the curve". In addition, our own James Lloyd will be giving a plenary presentation on “The Impact of UK REACH and GB CLP on Chemical Compliance in Europe”.
This virtual event will take place over five days and include plenary sessions, exhibits, poster session, sponsors, and networking. We are proud to be associated with an organization that for 40+years has been promoting, educating, and providing guidance on chemical hazard communication and product stewardship.
The event will be held on virtually Nov 1st- 5th . https://www.schc.org/index.php?option=com_jevents&task=icalevent.detail&evid=46
Stop by our booth to say hi and leave your business card to have an opportunity to win some goodies – a few that showcase our Irish roots.
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H2 Compliance will be sponsoring the Pharma Industry Awards of 2021, being held on November 11. The Pharma Industry Awards celebrate and recognise the most original and innovative individuals and organisations that demonstrate excellence in the Irish pharma industry.
Kevin Hoban of H2 Compliance will be presenting the Pharma Supplier of the Year award with a short list of 11 finalists. This award will recognise the ‘best in class’ service in Ireland’s constantly growing pharmaceutical industry. The short lists for all awards have been revealed and can be seen here. Other award categories will include Pharma Industry Company of the Year, Pharma Leader 2021, Biotech Company of the Year and Health and Safety .
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Check out H2 Compliance and the Pharma Industry Awards on LinkedIn over the next couple of weeks for all updates.
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In order to connect circular economy-minder people and help startups take their next step, in 2014 Landbell Group established Europe’s first startup prize for the Circular Economy .
The Green Alley Award offers a unique chance to network – and the most-promising startup takes home a prize money of 25.000 €.
Only startups no older than 5 years that are located in Europe can apply for the Green Alley Award. We also accept startups that have not yet incorporated their business. Startups applying for the Green Alley Award have to fit into one of the following categories:
- Recycling
- Waste prevention
- Digital Solutions
Out of all applicants, a total of six startups will be invited to our Grand Finale in Berlin. Five of the six finalists are chosen by our committee, the sixth is nominated by a public voting from a preselected number of startups.
If you want cooperate with startups promoted by the Green Alley Award, contact us at cooperate-gaa@landbellgroup.com or find out more here. The Green Alley Award is a unique opportunity to be at the heart of new trends, grow your market position and benefit from the smartest innovators in your industry.
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In consortium with BlackForest Solutions and local experts, Landbell Group will contribute to the elaboration and dissemination of innovative solutions for the reduction, reuse and recycling of plastic waste and plastic packaging in three Indian states: Kerala, Tamil Nadu and Uttar Pradesh.
This mission will be accomplished within the project “Circular Economy Solutions Preventing Marine Litter in Ecosystems” under the supervision of the German Agency for International Cooperation (GIZ).
During the 12-month assignment, the consortium will deliver four work packages:
- Inventory of and advice on relevant technologies for reducing plastic use and packaging or improving recyclability in the production process;
- Improving reuse and take-back mechanisms in retail and consumption;
- Identification of technologies for improving registration and tracking of packaging waste for an extended producer responsibility (EPR) and/or plastic credit system; and
- Identification of suitable technologies for better waste collection, sorting, recycling of plastic waste and capturing plastic litter (both in rivers and on land).
In addition to delivering reports, recommendation papers and technical concepts, the consortium will facilitate dialogue with plastic producers, industry associations, recycling companies and state/national institutions in charge of EPR system set-up.
The project ties in with India’s efforts to phase out single-use plastics by 2022 and implement EPR and third-party monitoring mechanisms.
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