eu monitoring report 28 may – 5 june 2020 … · substance – one assessment’ and to provide...

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EU Monitoring Report 28 May – 5 June 2020 CONTENTS EUROPEAN CHEMICALS AGENCY ....................................................................2 REACH...................................................................................................................................... 2 ECHA outlines EU cross-agency 'one substance – one assessment' plan .................... 2 Active chlorine released from hypochlorous acid update of Article 95 ........................... 3 Update to substitution plan format for REACH authorisation applications ..................... 3 Invalidating registrations during evaluation .................................................................... 4 CLH ........................................................................................................................................... 4 Registrations of intentions for CLH for 3 new substances.............................................. 4 ECHA’s Safer Chemicals Conference now content available ........................................ 4 FORMALDEHYDE .................................................................................................................... 5 ECHA postpones decision on draft opinion for formaldehyde restriction ....................... 5 COVID-19.................................................................................................................................. 6 EU Member States report illegal and ineffective disinfectants ....................................... 6 EUROPEAN COMMISSION ..................................................................................7 REACH...................................................................................................................................... 7 REACH Committee: Summary of the 13 May meeting .................................................. 7 Stronger EU policy key to safer chemicals switch – Commission director ..................... 7 STAKEHOLDERS .................................................................................................9 ENDOCRINE DISRUPTORS .................................................................................................... 9 EU member states publish inaugural lists of EDCs ........................................................ 9 REACH.................................................................................................................................... 11 SMEs call for wider definition of REACH intermediates ............................................... 11 Minister seeks to allay concerns about UK REACH transparency ............................... 13 Experts warn of disinfectants 'cliff-edge' when derogations expire .............................. 15 Demanding customers and strict regulations: ethical swimming pools with Pentair .... 17 Chemicals industry join EU Parliament’s intergroup on sustainable investments ........ 17 Chemical industry’s stance on achieving climate neutrality in the EU.......................... 18 BREXIT ................................................................................................................................... 18 'Independent' UK REACH will kick off from 1 January ................................................. 18 EVENTS .................................................................................................................................. 19 24 September: Obligations for export of hazardous chemicals outside the EU ........... 19 9 June: SME verification – getting your company size right ......................................... 19 19 June: An interview on DSM's drive towards greater transparency .......................... 19 9 July: Circular economy-focused waste and recycling case studies........................... 20 24 July: Flame retardants in electronics ....................................................................... 20 14 July: Where is the UK Heading on Chemicals Trade? ............................................ 20 30 September: Enforcement Summit 2020 .................................................................. 21

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Page 1: EU Monitoring Report 28 May – 5 June 2020 … · substance – one assessment’ and to provide greater transparency when prioritising action to deal with chemicals". During ECHA’s

EU Monitoring Report 28 May – 5 June 2020

CONTENTS

EUROPEAN CHEMICALS AGENCY .................................................................... 2 REACH ...................................................................................................................................... 2 • ECHA outlines EU cross-agency 'one substance – one assessment' plan .................... 2 • Active chlorine released from hypochlorous acid update of Article 95 ........................... 3 • Update to substitution plan format for REACH authorisation applications ..................... 3 • Invalidating registrations during evaluation .................................................................... 4

CLH ........................................................................................................................................... 4 • Registrations of intentions for CLH for 3 new substances .............................................. 4 • ECHA’s Safer Chemicals Conference now content available ........................................ 4

FORMALDEHYDE .................................................................................................................... 5 • ECHA postpones decision on draft opinion for formaldehyde restriction ....................... 5

COVID-19 .................................................................................................................................. 6 • EU Member States report illegal and ineffective disinfectants ....................................... 6

EUROPEAN COMMISSION .................................................................................. 7 REACH ...................................................................................................................................... 7 • REACH Committee: Summary of the 13 May meeting .................................................. 7 • Stronger EU policy key to safer chemicals switch – Commission director ..................... 7

STAKEHOLDERS ................................................................................................. 9 ENDOCRINE DISRUPTORS .................................................................................................... 9 • EU member states publish inaugural lists of EDCs ........................................................ 9

REACH .................................................................................................................................... 11 • SMEs call for wider definition of REACH intermediates ............................................... 11 • Minister seeks to allay concerns about UK REACH transparency ............................... 13 • Experts warn of disinfectants 'cliff-edge' when derogations expire .............................. 15 • Demanding customers and strict regulations: ethical swimming pools with Pentair .... 17 • Chemicals industry join EU Parliament’s intergroup on sustainable investments ........ 17 • Chemical industry’s stance on achieving climate neutrality in the EU .......................... 18

BREXIT ................................................................................................................................... 18 • 'Independent' UK REACH will kick off from 1 January ................................................. 18

EVENTS .................................................................................................................................. 19 • 24 September: Obligations for export of hazardous chemicals outside the EU ........... 19 • 9 June: SME verification – getting your company size right ......................................... 19 • 19 June: An interview on DSM's drive towards greater transparency .......................... 19 • 9 July: Circular economy-focused waste and recycling case studies ........................... 20 • 24 July: Flame retardants in electronics ....................................................................... 20 • 14 July: Where is the UK Heading on Chemicals Trade? ............................................ 20 • 30 September: Enforcement Summit 2020 .................................................................. 21

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EUROPEAN CHEMICALS AGENCY

REACH

• ECHA outlines EU cross-agency 'one substance – one assessment' plan Source: Chemical Watch

ECHA’ executive director Bjorn Hansen has proposed ways in which EU agencies can collaborate to ensure that any given chemical is assessed only once, easing the pressure on companies trying to keep on top of developments under separate regulations. Until now, multiple agencies have assessed the same chemicals via different legislation.

Under the framework of the chemicals strategy for sustainability, due later this year, the European Commission has committed to reviewing how to "better" use the EU’s agencies and scientific bodies "to move towards a process of ‘one substance – one assessment’ and to provide greater transparency when prioritising action to deal with chemicals".

During ECHA’s virtual Safer Chemicals Conference on 2 June, Mr Hansen said "combining all the efforts done under separate instruments at different times" would lead to a "more efficient holistic assessment" of chemicals.

In order to do that, one of the necessary actions is to "collaborate better with our sister agencies in order to gain efficiencies and accelerate getting to the risk management [stage]", he said. The plan would encourage collaboration between:

• the European Chemicals Agency (Echa); • the European Food Safety Authority (Efsa); • the European Environment Agency (EEA); and • the European Medicines Agency (EMA).

More information (subscription needed): https://chemicalwatch.com/123226/hansen-outlines-eu-cross-agency-one-substance-one-assessment-plan

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• Active chlorine released from hypochlorous acid update of Article 95 Source: European Chemicals Agency

The recently updated Article 95 list includes a new entry for Active chlorine released from hypochlorous acid (redefined from active chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ).

ECHA is responsible for the publication of the list of relevant substances and the respective substance and product suppliers, in accordance with Article 95 of the Biocidal Products Regulation (BPR). The purpose of this list is to "ensure the equal treatment of persons placing active substances on the market".

The new entry lists the registration of active chlorine released from hypochlorous acid for 5 types of disinfectant products: PT 1 human hygiene products; PT 2: disinfectants/algaecides; PT 3: veterinary hygiene; PT 4: food and feed; and PT5: drinking water. The registration is listed for McElwaine Technical Services Limited, a supplier of substances and products based in the UK.

More information: https://echa.europa.eu/documents/10162/27434452/art_95_list_en.pdf/c752c5ae-358c-e84b-652a-fb98106dfe8e

• Update to substitution plan format for REACH authorisation applications Source: European Chemicals Agency

ECHA has updated the substitution plan format for REACH applications for authorisation. A substitution plan must be submitted as part of an application if there are suitable alternatives but they are not yet technically or economically possible for the specific use. This will help its scientific committees make their assessment. The updated format follows a ruling from the General Court on the European Commission’s decision on authorising the use of lead chromate pigments.

More information: http://elmlinks.echa.europa.eu/m/1/93307195/p1-b20155-3129906424594753b55e83ec337bcf07/15/143/627b5da8-6d1b-49ee-9e47-0f223d6f4820

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• Invalidating registrations during evaluation Source: European Chemicals Agency

ECHA is no longer asking companies to confirm they have stopped manufacturing or importing a substance following a draft decision under dossier or substance evaluation. The agency will act to invalidate the registration – in accordance with Article 50(3) of REACH – as soon as the company indicates this is the case in REACH-IT. It will then notify them that the registration is no longer valid.

More information: http://elmlinks.echa.europa.eu/m/1/93307195/p1-b20155-3129906424594753b55e83ec337bcf07/15/143/627b5da8-6d1b-49ee-9e47-0f223d6f4820

CLH

• Registrations of intentions for CLH for 3 new substances Source: European Chemicals Agency

The European Chemicals Agency has added new substances to the Registry of intentions of classification and labelling harmonisation (CLH). The registry of ‘CLH intentions until outcome’ lists the intentions and proposals received by ECHA for a new or revised harmonised classification and labelling of a substance. The proposals are submitted by Member State competent authorities, manufacturers, importers or downstream users. The relevant intentions and proposals are:

• benthiavalicarb isopropyl • 5-chloro-2-methyl-2H-isothiazol-3-one • hydrogen sulphide

More information: https://echa.europa.eu/view-article/-/journal_content/title/echa-weekly-3-june-2020

• ECHA’s Safer Chemicals Conference now content available Source: European Chemicals Agency

The content from ECHA's 2 June online conference is now available. The entire conference is available on YouTube. ECHA replied to 120 questions on hazardous

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substances in products, poison centres and other topics. AliénorEU will review the content and inform you of relevant information.

More information: https://echa.europa.eu/fr/-/safer-chemicals-conference-2020

FORMALDEHYDE

• ECHA postpones decision on draft opinion for formaldehyde restriction Source: Chemical Watch

A decision on ECHA’s Socio-economic Analysis Committee’s (SEAC) draft opinion of a proposal to restrict formaldehyde and its releasers has been postponed until September. It follows ECHA accepting a stakeholder request to submit information after the 25 May consultation deadline, because of difficulties arising from the coronavirus Covid-19 pandemic. The draft opinion was due to be considered at SEAC's meeting next week, but this will now happen at its meeting in the autumn.

The restriction dossier, submitted in January last year by ECHA at the request of the European Commission, proposes to restrict the placing on the market of articles releasing formaldehyde at concentrations greater than 0.124mg/m³.

The proposal says formaldehyde is a high production volume chemical with a wide array of uses and is "highly irritating to the upper respiratory tract", therefore requiring EU-wide action. Formaldehyde is mainly used in the production of formaldehyde-based resins for adhesives and binders.

SEAC’s draft opinion agrees with the proposed limit value, adding that complying is "technically and economically feasible for the industry". The draft notes that the World Health Organization (WHO) Guideline for Indoor Air Quality for formaldehyde sets an exposure limit to 0.1mg/m³ (0.08 parts per million) for all indoor environments.

However, the opinion of ECHA’s Risk Assessment Committee (RAC), adopted on 13 March, recommends 0.05mg/m³. SEAC "recognises the higher protective potential of the limit values set by the RAC" but "lacks sufficient information on the technical feasibility, costs and benefits" of setting its proposed limit.

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In May the European Commission published a draft implementing Regulation that would approve the biocidal active substance formaldehyde for use in disinfectants and algaecides not intended for direct application to humans or animals.

More information (subscription needed): https://chemicalwatch.com/123098/echa-postpones-decision-on-draft-opinion-for-formaldehyde-restriction

COVID-19

• EU Member States report illegal and ineffective disinfectants Source: European Chemicals Agency

Several EU countries have signalled to ECHA and the European Commission that the COVID-19 pandemic has led to an increased number of non-compliant (hand) disinfectants on the market. National enforcement authorities are taking action to protect citizens from the risks of illicit and ineffective products.

The high demand for disinfectants to fight COVID-19 and the granting by Member States of health emergency permits have attracted new producers and suppliers to the market. These companies may not have prior knowledge of the applicable legal framework, and although many act in good faith and use all the available help offered by ECHA and national authorities, some appear to be taking advantage of the situation. 20 EU Member States have reported an increase in non-compliant (hand) disinfectants on their markets since March 2020.

Many of them reported cases of disinfectants that do not have the required authorisation or permit, or lack hazard labelling.

More information: https://echa.europa.eu/-/eu-member-states-report-illegal-and-ineffective-disinfectants

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EUROPEAN COMMISSION

REACH

• REACH Committee: Summary of the 13 May meeting Source: European Commission

The REACH Committee met on 13 May 2020. Due to the COVID-19 pandemic, this was organised as an on-line meeting. A summary of the online meeting is now available. The Committee received an update on the state of play of the Chemicals Strategy for Sustainability and was informed that a Roadmap is now published for consultation on the Commission’s Better Regulation Portal.

More information: https://ec.europa.eu/transparency/regcomitology/index.cfm?do=search.documentdetail&Dos_ID=19259&DS_ID=67485&Version=1

• Stronger EU policy key to safer chemicals switch – Commission director Source: Chemical Watch

A stronger regulatory framework that sets "high standards and predictable rules" is vital in order to facilitate a full switch to safer chemicals in the EU, a director from the European Commission has said.

Speaking at Echa’s virtual Safer Chemicals Conference yesterday, Kestutis Sadauskas, director of circular economy and green growth at DG Environment, said: "Europe has the scientific and technical capacity to lead the transition to safe chemicals and non-chemical alternatives from design to end of life."

However, to achieve this transition, stronger policy support is needed, he added. His comments come as the European Commission continues work on its delayed chemicals strategy for sustainability, which is part of the EU Green Deal set out last year. The strategy, originally promised for the summer, is now expected in September.

Despite the "achievements" of EU chemicals legislation so far, he added, "not all citizens are protected equally and not all chemical risks are addressed. We urgently need to step up action, in particular to strengthen protection of vulnerable

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groups, to address the combined effects of chemicals, to ensure the sound management of endocrine disruptors and to tackle persistent substances such as PFASs."

Substitution

"Despite our best efforts, substitution of hazardous substances has not happened at the required pace," Mr Sadauskas said. "Most substances on the European market are still hazardous to health and the environment. And front-runners who produce and use chemicals more safely still encounter major economic and technological barriers."

In a separate presentation, ECHA head Bjorn Hansen gave examples of how the agency can help industry switch to safer alternatives. ECHA, he said, can assist those "forward-thinking and forward-looking" companies by providing data "transparency [...] and triggering a demand for sustainability" by further opening up access to the information and knowledge in ECHA‘s possession.

"But that alone does not enable us to move quickly from the chemicals we have today to those we need tomorrow," he added. "We need a push effect, which means the laggards, those who are not the forefront ... are pushed … towards sustainable chemicals and the best instrument to frame that push effect is consistent and efficient regulation."

In order to attain this, Mr Sadauskas said, coherence across policy objectives and legislation must be ensured. "We need that to ensure that we protect consistently and that we do not trade health and environment protection with other goals. This is very relevant for the circular economy agenda, [whose] key objectives in terms of resource use will not be met if we don’t ensure non-toxic material cycles and therefore a clean loop."

Swift execution

Mr Hansen emphasised the need for ECHA and member states to accelerate their regulatory efforts. This is an "essential element" to better protect citizens by ensuring safety of chemicals and products, he said.

The goal of generating safety data more quickly is in line with the joint ECHA-Commission REACH compliance check action plan, Mr Hansen said. This sets a

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target for the agency to scrutinise all dossiers for chemicals registered over 100 tonnes a year by the end of 2023.

ECHA’s grouping approach, a fundamental part of its exercise to map the chemicals universe, "is one that we expect will help us speed up" assessment of hazardous substances, he added.

Last month, an NGO questioned the feasibility of the agency meeting its end-of-year deadline to allocate all substances above 100 tonnes a year to three distinct chemical universe ‘pools’ for potential regulatory action.

More information (subscription needed): https://chemicalwatch.com/122316/stronger-eu-policy-key-to-safer-chemicals-switch-commission-director

STAKEHOLDERS

ENDOCRINE DISRUPTORS

• EU member states publish inaugural lists of EDCs Source: Chemical Watch

Four member states have collaborated to produce the first comprehensive lists of endocrine disrupting chemicals (EDCs) in Europe, in an effort to accelerate regulatory and industry action on the substances. The website, which contains three lists and launched on 2 June, is spearheaded by the Danish environment ministry and supported by corresponding ministries in France, the Netherlands and Sweden.

It comes ahead of the results of the European Commission’s fitness check exercise to comprehensively screen existing legislation related to EDCs. The Commission will finalise the exercise by the end of 2020. It is part of a strategy outlined in 2018. The chemicals have been allocated to three categories:

• list I: substances identified as EDCs at EU level; • list II: those under evaluation for endocrine disruption under EU legislation; • list III: substances considered, by the evaluating national authority, to have

endocrine disrupting properties.

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List I currently consists of 19 chemicals that have undergone an evaluation of ED properties, as regulated under REACH and the EU’s biocidal products (BPR) and plant protection products regulations (PPPR), and have been confirmed as EDCs.

List II contains 84 substances that are currently being assessed due to concerns for possible ED properties under REACH – on the community rolling action plan (Corap) list – or as part of the mandatory process for approval or renewal under the BPR and PPPR.

Finally, list III features nine chemicals that are not necessarily considered as suspected EDCs at EU level. The Commission or member states may decide at a later stage on the need for further evaluation of these substances.

Slow progress

The Commission’s progress in protecting human health and the environment against EDCs "is way too slow", Danish environment minister Lea Wermelin said.

The country has focused on endocrine disruptors "for many years" and has "put constant pressure on the EU as we can’t keep on waiting", she added. The new website "brings us a step closer. It’s a tool that can help speed up the process towards stronger regulation," Ms Wermelin said. The aim, she said, is for all EU member states and industry, in particular, to use the lists to avoid harmful substances until EU regulation is in place.

The four ministers informed the EU commissioners for health, the environment and agriculture, as well as the heads of Echa and the European Food Safety Authority (Efsa), about their website in a 19 May letter, recently shared with Chemical Watch.

The ministers said that "eventually" the information on the website "should be included in the Commission’s 'one-stop-shop web portal on endocrine disruptors'", as announced in its 2018 Communication. Additionally, they said they hoped the work will contribute to the ongoing initiatives in the EU on EDCs and boost dialogue around this.

Collaboration with EU agencies/institutions on the further development of the website "in order to increase the awareness and transparency" on EDCs would be a positive step, they said.

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Reaction

Commenting on the website, NGO coalition EDC-Free Europe said it welcomes this joint initiative as it "facilitates access" to information. It also "demonstrates that much more needs to be done to speed up the identification of EDCs and to take actions to minimise exposure to these harmful chemicals".

Meanwhile, Cefic said it agrees with the need to provide "evidence-based information about substances with established endocrine disrupting properties as identified" under the EU chemicals legislation.

"At the same time," it added, it should not be forgotten that the Commission is still working on the fitness check, and the upcoming chemicals strategy on sustainability "is also going to address this subject". This means the current approach to EDCs "may change soon", it said. More information (subscription needed): https://chemicalwatch.com/122781/eu-member-states-publish-inaugural-lists-of-edcs

REACH

• SMEs call for wider definition of REACH intermediates Source: Chemical Watch

ECHA needs to review its proposed guidance on intermediate uses of SVHCs under REACH and adopt a "fundamentally wider" definition so that more chemicals used in the production of articles qualify as intermediates, SMEunited has said.

The trade body disagrees with the agency's recent interpretation of a Court of Justice ruling in 2017 on the SVHC acrylamide, which clarified the conditions for intermediate uses. Echa has suggested amendments to its guidance in a paper submitted to the Competent Authorities for REACH and CLP (Caracal) ahead of their meeting at the end of June. The paper concludes that the overall impact of the ruling is "relatively small".

But SMEunited says that, on the contrary, the ruling would have "quite an impact" on how intermediate status has been understood until now.

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Echa's paper does not take the court's judgment fully into consideration and maintains a "problematic and questionable" status quo, says SMEunited adviser Marko Susnik. Some elements of it "could be actually opposing" the judgment, he told Chemical Watch. The trade body is calling for a wider interpretation, which could mean that more substances consumed in a production step are considered intermediates.

Intermediate uses are exempt from REACH authorisation and require lighter registration, because it is assumed that the risks arising from them are partly addressed in the registration of the manufactured substances.

According to Echa's data, as of end-May there were 17,715 registrations for intermediate uses under REACH, corresponding to 9,000 substances. Full registrations totalled 74,713, corresponding to 16,211 substances.

Impact on authorisation

SMEunited says that while the court's judgment does not imply a significant change in registration numbers – because criteria includes 'strictly controlled conditions' – there would be an "important impact" on authorisations.

Many SVHC uses have been authorised, especially for chromates, and some of them could qualify as intermediates and consequently be exempt from authorisation, the trade body argues. Chromates are mainly used in plating, for example, in tools and car doors. "The companies concerned would have applied for authorisation unnecessarily," Mr Susnik said.

Chromates authorisation is a contentious issue, with many MEPs and NGOs opposed to some of the European Commission's approvals. In the paper to Caracal, Echa and the Commission set out modifications to align the existing guidance on intermediates with the court's conditions.

It provides examples of where these conditions would apply, and concludes that most uses viewed as intermediate under the existing definition would not change. Similarly, uses that didn't previously qualify in most cases still would not do so. SMEunited says it disagrees with those conclusions in all of the examples.

In the acrylamide case, the court rejected Echa's position that the main purpose of intermediates must be to manufacture another substance and not to fulfil another

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function. REACH contains no additional criteria allowing differentiation according to whether the purpose was of primary or secondary nature, it ruled.

But SMEunited says Echa could again be introducing such a differentiation, something the court was "explicitly opposed" to. It has submitted its feedback to Caracal. The period for comments will begin after the Caracal meeting on 30 – 1 July. Stakeholders usually have five weeks to do so.

More information (subscription needed): https://chemicalwatch.com/123099/smes-call-for-wider-definition-of-reach-intermediates

• Minister seeks to allay concerns about UK REACH transparency Source: Chemical Watch

An independent REACH regime the UK looks set to implement from 1 January, will mirror the EU in its provisions for transparency and stakeholder engagement in regulatory decisions, a UK minister has said.

Seeking to reassure MPs and NGOs concerned about reduced oversight, Rebecca Pow, parliamentary undersecretary of state at the Department for Environment, Food and Rural Affairs (Defra), said the government would ensure that, under UK REACH, the regulatory processes "can be properly held to account".

"We will keep the same level of transparency and stakeholder engagement in the opinion forming processes as our EU equivalent and be able to draw from a pool of scientific experts as required," she said in her 22 May response to a letter from Environmental Audit Committee (EAC) chair Philip Dunne.

The comments follow concerns that a standalone UK regulator could not replicate Echa, given the lack of capacity, access to data and ability to draw on myriad experts and stakeholders through advisory committees. They have asked for more checks and balances to be built into legislation to replicate relevant provisions of EU law.

A particular cause for apprehension is the power given to the secretary of state for environment to amend UK REACH and the enforcement regulations. In her letter, made public on 29 May, Ms Pow says "certain decisions" will be made by the Defra secretary of state.

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Along with the Health and Safety Executive (HSE) operating as the UK agency, this "echoes" the relationship between Echa and the European Commission "in terms of responsibilities and decision making".

And to ensure sufficiency of scientific discussions, the HSE will publish an open call for regular and occasional observers, similar to Echa's approach to appointing accredited stakeholder organisations to observe committee meetings, Ms Pow adds. The eligibility criteria will be based on those Echa uses. However, there is no statutory role for external stakeholders and committees in the substance evaluation process, "as is also the case in REACH".

Scientific advice

The HSE will also set up a pool of independent scientific advisers through an open application process, the minister says. Candidates will be "sifted against competence and eligibility criteria", while the Environment Agency will help ensure the selection of advisers includes "environmentally qualified candidates as well". Furthermore, the HSE and EA "will be free" to consult on specific issues with experts from scientific bodies such as the Committee on Toxicity (CoT) and Hazardous Substances Advisory Committee (HSAC).

The EAC is due to have the secretary of state for environment, George Eustace, give evidence on 18 June. NGO CHEM Trust’s executive director Michael Warhurst said the new proposals on decision-making processes and for observers to be part of it were "a start". But they still fall short of the open and more transparent structures within Echa, he said.

Ms Pow's letter also does not address some of the key reasons why the HSE will be weaker than Echa, especially that its database will be much smaller and that essentially it will have no usable data for the first two years, Mr Warhurst said. The Chemical Industries Association (CIA) said it was clear to both the UK and EU that two separate legal frameworks will exist to regulate chemicals. Together with Cefic, it has called for a data-sharing mechanism allowing the UK to assess chemicals without the need to duplicate costly data submissions.

More information (subscription needed): https://chemicalwatch.com/122680/minister-seeks-to-allay-concerns-about-uk-reach-transparency

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• Experts warn of disinfectants 'cliff-edge' when derogations expire Source: Chemical Watch

Companies that pivoted to producing disinfectants during the Covid-19 crisis could soon find themselves marketing products illegally as exemptions come to an end, a chorus of experts has warned.

Speaking at the Chemical Watch Biocides Symposium last week, consultants and lawyers said it is uncertain how many hand and surface sanitisers will remain on the market. The disinfectants industry, meanwhile, confirms demand is as high as ever. Europe has been coping with the surging demand for hand and surface sanitisers by exempting these products from the usual legal requirements of the EU’s biocidal products Regulation (BPR).

The derogations are made under a clause in Article 55 of the BPR and only last for a maximum of 180 days. EU member states have implemented them at different times but the majority will expire in September 2020. New disinfectant suppliers, who entered the market under these legal exemptions, are unaware that the end of the derogations means they have to comply with the BPR’s normal, strict rules, said David Ashworth, the managing director of Klarus Consulting.

"Many people don’t realise that at the end of the derogations ... it’s an absolute cliff edge removal from the market," he said. "I think that’s something that a lot of people have to get their heads around very quickly."

Those wanting to keep selling disinfectants will have to provide evidence that their product is safe and effective. But testing products may come up against full capacities at laboratories, which are prioritising Covid-19 work, Mr Ashworth said.

National derogations can be extended, on request, for a further 550 days by the European Commission. But companies should expect that "a lot of what is being used and relied upon now to place disinfectants on the market will expire, either because there is no extension sought [by the member state] or no extension is granted [by the Commission]," said Eléonore Mullier, a senior associate at law firm Steptoe & Johnson.

The impact will especially hit unlikely providers of hand sanitisers, such as distilleries, who may be "lost in terms of BPR rules", Ms Mullier warned.

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Steptoe and Johnson contributed to a guide to BPR rules, aimed at such companies, which was published in April by trade bodies for soaps and detergents (Aise), chemical distributors (Fecc) and biocidal products (EBPF), along with the Consultancy for Environmental & Human Toxicology and Risk Assessment (Cehtra) and law firm, Fieldfisher.

High demand

While current derogations are expiring, biocides authorities might introduce exemptions for other products as the easing of lockdown measures across Europe heightens demand for disinfectants in public places. Exemptions for disinfectant hand wipes, for instance, would have utility in restaurants, said Gerard McElwee, counsel at Fieldfisher.

"Down the line, there will be a need to forecast what the demand of consumers will be for biocides and how to address these demands," he said. "I think this is something that industry can’t do alone. We have to work with authorities."

Aise told Chemical Watch after the Symposium that demand for disinfectants will "remain very high or even increase further" with the lifting of confinement measures. It added that the availability of biocidal active substances, such as ethanol and propanol, is "still very limited".

The trade body demands that authorities "continue treating the issue as a high priority" and asks for "cooperation between authorities and leadership from the Commission". At the same time, Aise is fighting against illegal and non-compliant products, it says: "Free-riders should not remain on the market."

The Danish competent authority told the Symposium that its enforcement activities are now focused almost exclusively on disinfectants. The country’s EPA had counted 65 reports of non-compliant products by 1 May, said deputy head of the biocides division, Henrik Svenstrup.

Once derogations expire, inspectors will work their way through the list of companies that made use of them and apply "general rules" of enforcing the BPR, Mr Svenstrup said.

More information (subscription needed): https://chemicalwatch.com/122317/experts-warn-of-disinfectants-cliff-edge-when-derogations-expire

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• Demanding customers and strict regulations: ethical swimming pools with Pentair Source: Euro Spa Pool news

Studies and analysis show that, day by day, consumers are increasingly questioning how they are consuming things and the products they are buying. As they are more demanding, their expectations are turning towards products that meet their concerns, both in terms of energy and resource consumption and safety for their health and the environment.

The growing number of strict environmental regulations is having an increasing impact on swimming pool specialists and is already heavily affecting the swimming pool sector all over Europe. Many swimming pool specialists have already taken them on board and offer an increasingly ethical range of pools, thanks to the installation of equipment that simplifies, improves and automates the running of a pool.

More information https://www.eurospapoolnews.com/actualites_piscines_spas-en/65790-keepintouch,ecological,swimming,pools,savings,energy,products,automation,ethical,commitment,pentair.htm

• Chemicals industry join EU Parliament’s intergroup on sustainable investments Source: European Parliament Magazine

European Association of Chemical Distributors (Fecc) has become an accredited partner of the European Parliament’s newly formed intergroup ‘Sustainable, long-term Investments & Competitive European Industry’ for the legislative period 2019-2024. The intergroup, which was formally established in the middle of February offers a platform for exchange with political, industry and societal stakeholders to promote dialogue on the future of the industry and long-term investments in Europe. The European Chemical Industry Council (Cefic) has also become an accredited partner of the European Parliament’s intergroup ‘Sustainable, long-term Investments & Competitive European Industry’ for the legislative period 2019-2024.

More information: www.theparliamentmagazine.eu/articles/news/movers-and-shakers-29-may-2020

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• Chemical industry’s stance on achieving climate neutrality in the EU Source: European Chemical Industry Council

In March this year, the European Commission came forward presenting its proposal for the first EU-wide climate law. The law, once finalised, intends to enshrine the EU objective of climate neutrality by 2050 in legislation. Cefic supports the European Green Deal and Europe’s ambition to become climate neutral by 2050, announced by Marco Mensink, Cefic Director General in March. As recognised in the European Green Deal Communication, Energy Intensive Industries, such as chemicals, are indispensable to Europe’s economy, as we supply key value chains.

“The Commission’s draft Climate Law clearly defines the ‘what and why’, it’s now essential to lay out a path how Europe can become climate neutral by 2050. We need a plan to stimulate the investments required to deliver the Green Deal objectives. The Commission’s Next Generation Recovery Plan is the first step in this direction”, the Cefic Executive Director for Climate Change and Energy stated.

Cefic identifies that an overhaul of the current legislative and policy framework is needed to meet the climate-neutrality challenge and the huge societal transformation that it requires. “The updated framework should look towards society at large and recognise the complexity and interlinkage between sectors of the economy.”

More information: https://cefic.org/media-corner/newsroom/achieving-climate-neutrality-by-2050

BREXIT

• 'Independent' UK REACH will kick off from 1 January Source: Chemical Watch

The UK will activate its independent REACH regime from 1 January 2021 when the Brexit transition period ends, Rebecca Pow, MP and parliamentary undersecretary of state at the Department for Environment (Defra), has said.

More information (subscription needed): https://chemicalwatch.com/122258/independent-uk-reach-will-kick-off-from-1-january

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EVENTS

• 24 September: Obligations for export of hazardous chemicals outside the EU Source: European Chemicals Agency

If you are planning to export hazardous chemicals outside the EU, you will most likely have to comply with the PIC Regulation. It covers for example industrial chemicals, pesticides, or biocides that are banned or severely restricted in the EU. The webinar explains the scope and main requirements of the PIC Regulation. You will learn how to notify your exports and the conditions that require explicit consent from the importing countries.

More information: https://echa.europa.eu/fr/-/know-your-obligations-when-exporting-hazardous-chemicals-outside-the-eu

• 9 June: SME verification – getting your company size right Source: European Chemicals Agency

Join this webinar to learn about the steps you need to take to make sure your company size has been declared correctly to avoid unnecessary fees.

More information: https://echa.europa.eu/fr/-/sme-verification-getting-your-company-size-right

• 19 June: An interview on DSM's drive towards greater transparency Source: Chemical Watch

In this webinar Sjoerd Dijkstra, marketing manager sustainability at DSM Resins, will answer questions from Leigh Stringer, our global business editor, on the theme of chemical transparency. They will explore DSM’s business strategy focusing on its drive towards greater transparency which includes setting phase-out goals for eliminating carcinogen, mutagen and reproductive toxicants (CMRs) and persistent, bioaccumulative and toxic (PBT) substances by 2025.

More information: https://events.chemicalwatch.com/118010/cw-interview-a-deeper-dive-into-dsms-new-business-strategy-and-hazard-based-approach-to-chemicals-19-june-2020

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• 9 July: Circular economy-focused waste and recycling case studies Source: Chemical Watch

This 90- minute broadcast will bring you three company case studies, all discussing aspects of their waste and recycling efforts within the circular economy. In detail, the case studies are:

• Chemicals management in support of a sustainable value chain for rechargeable batteries, presented by Umicore.

• Plastics additives: SAFR®, a flame retardant selection tool to more fully realise sustainability goals while optimising product safety

• ‘Plastics to Chemicals’: chemical recycling for secondary raw materials with SVHCs removed, presented by Indaver NC and Apeiron-Team.

More information: https://events.chemicalwatch.com/122706/circular-economy-focused-waste-and-recycling-case-studies-9-july-2020

• 24 July: Flame retardants in electronics Source: Chemical Watch

During this one-hour webinar, speakers will discuss the most important scientific and policy developments around flame retardants used in the electronics industry from a European and North American perspective.

More information: https://events.chemicalwatch.com/121544/flame-retardants-in-electronics-25-june-2020

• 14 July: Where is the UK Heading on Chemicals Trade? Source: Chemical Watch

This virtual conference is the latest in our series of events examining the impact of Brexit on UK chemical legislation. This conference will explore how the UK’s departure from the EU and its trade agreements with other countries after the transition period ends might affect the chemicals industry and market access.

More information: https://events.chemicalwatch.com/113636/where-is-the-uk-heading

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• 30 September: Enforcement Summit 2020 Source: Chemical Watch

The eighth annual Enforcement Summit offers special perspectives and understanding of European and global regulatory enforcement challenges. Over two days, expert speakers from government regulators, industry and consultancies, will share their perspectives and understanding of European and global regulatory enforcement challenges, including:

More information: https://events.chemicalwatch.com/119281/enforcement-summit-2020-30-1-october-2020