ECHA- Actualités

ECHA Actualités: Share information about REACH 2018, new infographic available; 53 new substances to be evaluated; New consultations for harmonised classification and labelling; New CLH consultation launched on the pesticide Spirodiclofen; Registry of intentions updated; RMOA of Copper Sulphide; Commission invites comments on restricting 291 substances; New version of Epic available, changes for companies notifying exports of mixtures; Epic tool update; Advice to epic chemicals exporters ; Are you planning to export PIC chemicals in 2016 ? Notify your intentions now; Update to guidance on information requirements and chemical safety assessment; Expert workshop on health impacts of chemicals; Board of Appeal decides in case a-006-2014 on the substance evaluation of Hexyl Salicylate


Enregistrement

« Share Information About REACH 2018 – New Infographic Available »-ECHA

« Do you know companies who are dealing with chemicals and might need to register them with ECHA to stay on the market after May 2018 ? Do you know companies who know their obligations but have not yet started the work? Share the information from our REACH 2018 web pages and remind them of their tasks with our new infographic. Remember also that preparing a registration can take anything between six months to three years. So, starting as soon as possible is key to a successful registration. (…) »
Sources :
ECHA Newsletter 28.10.2015 : http://is.gd/uf9bzJ
REACH 2018 web pages : http://echa.europa.eu/reach-2018

CORAP

« Evaluation- 53 New Substances To Be Evaluated »-ECHA

« ECHA has prepared a proposal to update the Community rolling action plan for 2016-2018. The Member States are planning to evaluate 138 substances, out of which 53 are newly selected. The final plan will be adopted in March 2016.
The draft plan has been prepared in close cooperation with the Member States, taking into account risk-based criteria for the selection of substances. ECHA encourages registrants of the listed substances to start coordinating their actions and to contact the evaluating Member States. (…)«
Sources :
http://www.mychemicalmonitoring.eu/news/a7b354a8-f13e-45f9-8721-d153194fe128/53_additional_substances_to_be_evaluated_in_Europe_in_2016-2018

ECHA Newsletter 28.10 : http://is.gd/uf9bzJ
News alert : http://echa.europa.eu/view-article/-/journal_content/title/draft-corap-to-evaluate-138-substances-in-2016-2018-published
Draft CORAP 2016–2018 : http://echa.europa.eu/documents/10162/13628/corap_2016_2018_en.pdf
Draft Corap list : http://echa.europa.eu/view-article/-/journal_content/title/draft-corap-to-evaluate-138-substances-in-2016-2018-published
Updated CORAP : www.mychemicalmonitoring.eu/dap/files/corap_2016_2018_en-draft.pdf

Classification& Etiquetage Harmonisés Consultations publiques

« New Consultations For Harmonised Classification And Labelling »-ECHA

« ECHA has launched public consultations on the harmonised classification and labelling (CLH) proposals for isobutyl methacrylate (EC 202-613-0, CAS 97-86-9) and 2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone (EC 404-360-3, CAS 119313-12-1). Isobutyl methacrylate is currently classified in Annex VI of the CLP Regulation. Its most common use is as a monomer for polymerisation or intermediate in synthesis of other chemicals. We invite you to provide comments on the hazard classes eye irritation, skin sensitisation and aquatic acute toxicity.
2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone also has a harmonised classification. It is used as a photosensitive agent in printing inks, pigmented coatings and photopolymers for imaging applications. We invite you to provide comments on reproductive toxicity. Submit comments by 11 December 2015. (…)»
Sources :
ECHA Newsletter 28.10 : http://is.gd/uf9bzJ
Current CLH consultations : http://echa.europa.eu/harmonised-classification-and-labelling-consultation

“New CLH Consultation Launched On The Pesticide Spirodiclofen”-ECHA

“ECHA has launched a public consultation on the harmonised classification and labelling (CLH) proposal for spirodiclofen (ISO); 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate (CAS 148477-71-8). Spirodiclofen has no harmonised classification in Annex VI of the CLP Regulation. It is an active substance used as an insecticide and acaricide. We invite you to provide comments on the following hazard classes: All physical hazards; All health hazards except respiratory sensitisation; All environmental hazards except hazardous for the ozone layer. Submit comments by 4 December 2015. (…)”
Sources:
http://echa.europa.eu/harmonised-classification-and-labelling-consultation
Newsletter ECHA 21.10.2015: http://is.gd/nSyjFI
Current CLH consultations : http://echa.europa.eu/harmonised-classification-and-labelling-consultation
CLH consultation spirodiclofen : http://echa.europa.eu/harmonised-classification-and-labelling-consultation/-/substance-rev/11001/term

Classification& Etiquetage Harmonisés- Registre d’intentions

« Registry Of Intentions Updated « -ECHA

« Two dossiers for harmonised classification and labelling were submitted by Germany: L-(+)-lactic acid; (2S)-2-hydroxypropanoic acid (EC 201-196-2, CAS 79-33-4) and pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one (CAS 123312-89-0).
The United Kingdom submitted a dossier for thifensulfuron-methyl (ISO); methyl 3-(4-methoxy-6-methyl- 1,3,5-triazin-2-ylcarbamoylsulfamoyl)thiophene-2-carboxylate (CAS 79277-27-3). (…)»
Sources :
ECHA Newsletter 28.10 : http://is.gd/uf9bzJ
Submitted CLH consultations: http://echa.europa.eu/web/guest/registry-of-submitted-harmonised-classification-and-labelling-intentions

“Registry Of Intentions Updated”-ECHA

Eight new CLH intentions have been added to the Registry of Intentions:

empenthrin (ISO) (CAS 918500-11-5)
dibutylbis(pentane-2,4-dionato-O,O’)tin (EC 245-152-0; CAS 22673-19-4)
theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione (EC 200-385-7; CAS 58-55-9)
ethylene oxide; oxirane (EC 200-849-9; CAS 75-21-8)
thiabendazole (ISO) (EC 205-725-8; CAS 148-79-8)
imidacloprid (ISO) (EC 428-040-8; CAS 138261-41-3)
p-mentha-1,3-diene; alpha-terpinene; 1-isopropyl-4-methylcyclohexa-1,3-diene (EC 202-795-1; CAS 99-86-5)
p-cymene; 1-isopropyl-4-methylbenzene (EC 202-796-7; CAS 99-87-6).

Two CLH dossiers were submitted by Germany:

dodecyl methacrylate (EC 205-570-6; CAS 142-90-5)
and tris(2-ethylhexyl) 4,4′,4 »-(1,3,5-triazine-2,4,6-triyltriimino)tribenzoate (EC 402-070-1; CAS 88122-99-0) (…) ».

Sources:
Newsletter ECHA 21.10.2015: http://is.gd/nSyjFI
Current CLH intentions : http://echa.europa.eu/web/guest/registry-current-classification-and-labelling-intentions
Registry of Intentions : http://echa.europa.eu/en/addressing-chemicals-of-concern/registry-of-intentions
Submitted CLH proposals : http://echa.europa.eu/web/guest/registry-of-submitted-harmonised-classification-and-labelling-intentions

Substances extrêmement préoccupantes

“RMOA Of Copper Sulphide”-ECHA

“A risk management option assessment (RMOA) of copper sulphide has concluded that no action is needed on it at this time. Copper sulphide was selected for assessment because REACH registration data said that, as used in the EU, it could contain an impurity with SVH properties. It therefore potentially fulfilled Article 57 criteria where the concentration limit of the impurity exceeded the generic concentration limit relevant for classification as a CMR category 1A/1B.  Also, the substance is registered for uses within the scope of authorisation. These include in:• processing aids;• lubricants, greases and release products; and • the production of brakepads.
However, a subsequent update of the registration data showed that copper sulphide, as used in the EU, does not contain the impurity that caused it to be selected. It will, though, be re-screened at a later date to consider new information.(…)”
Sources :
Newsletter ECHA 21.10.2015: http://is.gd/nSyjFI
RMOA copper sulphide: http://echa.europa.eu/en/addressing-chemicals-of-concern/substances-of-potential-concern/pact/-/substance-rev/3706/term

« Commission Invites Comments On Restricting 291 Substances »-ECHA

« The European Commission has launched a public consultation on its proposal to restrict 291 substances that are carcinogenic, mutagenic or toxic to reproduction (CMR). The aim is to target hazardous substances in textile articles and clothing for consumers. The Commission seeks views on whether its plan is proportional and enforceable, on potential socio-economic impacts and on the likelihood of the identified CMR substances being present in consumer textile articles. The list of CMR substances (individual substances or groups) covered by this possible restriction would be added as a specific appendix to Annex XVII to REACH and could be regularly updated. Please submit your comments at the latest on 22 January 2016. (…)»
Sources :
ECHA Newsletter 28.10 : http://is.gd/uf9bzJ
Public consultationCMR : http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8299

Export- Import de Produits chimiques dangereux

“New Version of EPIC Available – Changes For Companies Notifying Exports Of Mixtures”-ECHA

“An update of the IT tool used for submitting export and import notifications under the Prior Informed Consent (PIC) Regulation has now been published. It includes a change for companies notifying mixtures which contain a substance included in an Annex I group entry. (…)”
Sources :
Newsletter ECHA 21.10.2015: http://is.gd/nSyjFI
ePIC support page : http://echa.europa.eu/support/dossier-submission-tools/epic

“EPIC Tool Update”-ECHA

“Echa has updated the IT tool, used for submitting export and import notifications under the prior informed consent (Pic) Regulation.The new version includes a change for companies notifying mixtures containing a substance included in an Annex I group entry. Companies must now give a Cas or EC number for the actual substance used in the mixture, instead of just referring to the generic group entry.
The agency says this will help to:

• clearly identify the substance already in the notification (and not only in the safety data sheet);
• ensure faster decision making for the importing country; and
• simplify Article 10 reporting for companies as ePIC will automatically prefill the substance information.(…)”

Sources:
Newsletter ECHA 21.10.2015: http://is.gd/nSyjFI
EPic tool update : http://echa.europa.eu/view-article/-/journal_content/title/epic-a-new-ittool-for-exporters-and-importers-of-certain-hazardous-chemicals

“Advice To Epic Chemicals Exporters”-ECHA

“The agency is advising all exporters of ePic chemicals in 2016 to notify their intentions now. It has issued specific reminders to supply up-to-date information on importers, and that the IT tool ePic requires Cas/EC number of actual substance used in any mixture or article. The ePic IT user manual or Echa’s helpdesk are recommended for additional guidance. (…)”
Sources :
Newsletter ECHA 21.10.2015: http://is.gd/nSyjFI
Advice to ePic chemical exporters: http://echa.europa.eu/view-article/-/journal_content/title/echa-e-news-21-october-2015

“Are You Planning To Export PIC Chemicals In 2016? Notify Your Intentions Now”-ECHA

“To allow national EU authorities and ECHA enough time to process the notifications, and the importing countries time to respond, we recommend that you submit your export notifications for 2016 at your earliest convenience. When preparing your notification, we ask you to provide more detailed information about the importer. For example, up-to-date contact details with a full street address will help the authorities in the receiving country to process your notification faster.
Remember also that the new version of the IT tool ePIC requires those submitting notifications for mixtures/articles with group entries, to specify the CAS/EC number of the actual substance used in the mixture/article. If you have any doubts, have a look at the updated ePIC IT user manual or contact ECHA through our Helpdesk.(…)”
Sources:
Export notifications : http://echa.europa.eu/web/guest/regulations/prior-informed-consent/export-notification-procedure
ePIC user manual : http://echa.europa.eu/documents/10162/21731237/epic_usm_industry_en.pdf
News item : http://echa.europa.eu/view-article/-/journal_content/title/new-version-of-epic-now-available-changes-for-companies-notifying-exports-of-mixtures
Newsletter ECHA 21.10.2015: http://is.gd/nSyjFI
ECHA Helpdesk : http://echa.europa.eu/contact/helpdesk-contact-form

Guide ECHA

« Update to Guidance on Information Requirements and Chemical Safety Assessment (version 3.0) »-ECHA

« The agency is consulting on amendments to Chapter R.7b: Endpoint specific guidance (version 3.0), concerning the sediment compartment. Echa has published a corrigendum to Chapter R.7a of its Guidance on Information Requirements and Chemical Safety Assessment (IR&CSA). The agency says the Partner Expert Group (PEG) discussed and agreed additional text for a bullet point on respiratory sensitisation. It was to be added to avoid the possibility of misinterpretation or misunderstanding. However, it was accidentally omitted in drafting. (…)”
Sources
Newsletter ECHA 21.10.2015: http://is.gd/nSyjFI
Corrigendum IR&CSA guidance : http://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf
REACH guidance consultation : http://echa.europa.eu/support/guidance/consultation-procedure/ongoing-reach?panel=r7b-30

Conférences

« Expert Workshop On Health Impacts Of Chemicals »- ECHA

« The agency is to host an expert workshop in Helsinki on 11-12 January 2016 on the valuation of health impacts of chemicals. Participation is by invitation only and aims to facilitate exchange of ideas between researchers in North America and the EU. To be presented and discussed are state-of-the-art studies that elicit willingness-to-pay values for health endpoints, associated with hazardous chemicals.(…) »
Event details chemical health impacts workshop :
http://echa.europa.eu/news-and-events/events/event-details/-/journal_content/56_INSTANCE_DR2i/title/expert-workshop-on-valuing-the-health-impacts-of-chemicals

Contestations

« Board Of Appeal Decides In Case A-006-2014 On The Substance Evaluation Of Hexyl Salicylate »-ECHA

« In case A-006-2014, the appellant contested ECHA’s decision requesting an in vitro dermal absorption study, a 28-day repeated dose toxicity study and information on worker and consumer exposure, following the substance evaluation of hexyl salicylate. The Board of Appeal decision examines the scope of the substance evaluation process and the conditions that need to be met in order for the Agency to justify a request for further information. The Board of Appeal dismissed the appeal on the grounds that ECHA had not exceeded the scope of its powers in requesting exposure information from individual registrants and in requesting information on an endpoint that was not the reason for the inclusion of the substance in the community rolling action plan. The Board of Appeal also found that the request for a 28-day repeated dose toxicity study was proportionate as the test is necessary to clarify a potential risk to human health and the environment. (…) »
Sources :
ECHA Newsletter 28.10 : http://is.gd/uf9bzJ
Board of Appeal decisions : http://echa.europa.eu/web/guest/about-us/who-we-are/board-of-appeal/decisions/-/search-decisions/20/search/true

Publicités

Biocides- Actualités

Biocides Articles: Registry for biocidal products (R4BP3) updated; Contact your National helpdesk to check if your product falls under biocides legislation; Board of appeal dismisses Biocides data-sharing case


“Registry For Biocidal Products (R4BP 3) Updated”- ECHA

“A new version of R4BP (3.4) introduces the possibility to exchange XML files under “Ad-hoc communication”. The update also includes minor bug fixes and improvements in usability.(…)”
Sources:
Newsletter ECHA 21.10.2015: http://is.gd/nSyjFI
R4BP 3 support page : http://echa.europa.eu/support/dossier-submission-tools/r4bp

« Contact Your National Helpdesk To Check If Your Product Falls Under Biocides Legislation »-ECHA

« The European Commission and Member States have repealed the Manual of Decisions concerning the old Biocidal Products Directive. Companies who, on the basis of the manual, considered their product to be excluded from the scope of the biocides legislation can contact their national helpdesk to check whether the status has changed. If the product could now fall under the new Biocidal Products Regulation, companies can submit a declaration of interest to notify to ECHA until 3 October 2016. (…)»
Sources :
ECHA Newsletter 28.10 : http://is.gd/uf9bzJ
News item : http://echa.europa.eu/view-article/-/journal_content/title/manual-of-decisions-repealed-check-the-status-of-products-formerly-excluded-from-biocides-legislation-with-the-national-helpdesk

« Board Of Appeal Dismisses Biocides Data-Sharing Case »- Chemical Watch

« Echa’s Board of Appeal (BoA) has dismissed an appeal against Echa’s decision to grant a company inclusion on the biocidal product Regulation’s (BPR) Article 95 list of approved substance suppliers, without access to a vertebrate study. (…) »
Source :
https://chemicalwatch.com/43309/board-of-appeal-dismisses-biocides-data-sharing-case
BoA decisions :http://echa.europa.eu/web/guest/about-us/who-we-are/board-of-appeal/decisions/-/search-decisions/401/search/true
http://echa.europa.eu/web/guest/about-us/who-we-are/board-of-appeal/decisions/-/search-decisions/402/search/true

EU Makes Progress On REACH Enforcement Indicators

« Forum set for trial; member states have some concern.

The European Commission has made progress on the enforcement indicators it is developing. Speaking at Chemical Watch’s Enforcement Summit in Brussels, Miguel Aguado-Monsonet, policy officer at DG Grow, said that it appeared the process to calculate enforcement indicators at EU-level works. However he said further work is needed regarding both the data collected and calculations used.

Around 2,000 pieces of data have been collected to generate 12 EU-wide indicators from the 31 countries enforcing REACH and CLP. Some of that information has come from the REACH Article 117 reports that EU member states make every five years – the latest cycle required reports to be submitted in June this year.

According to the results, the average degree of compliance for REACH and CLP is 80 % across the EU, based on all types of inspection.

As a caveat, Mr Aguado-Monsonet said that this figure did not mean that the market is 80 % compliant, as enforcers often used intelligence to focus their activities on likely cases of non-compliance, which would push the percentage up.

Other EU indicators are:

  • penalties;
  • training; and
  • the number of complaints made against enforcement.

The Commission plans to combine the figures to come up with an overall indicator of enforcement. 2010 will be used as a base line.

It has been working with Echa’s Enforcement Forum to develop three sets of indicators. In addition to the EU-wide set, 16 have been proposed for both the Forum and for member states to use at national level.

The Forum is scheduled to discuss the indicators at its meeting in November, says its deputy chair Eugen Anwander. He expects the members to come with data to feed into the indicators to get a feel for how they would work.

He noted that some member states are cautious about the national-level indicators, adding that context will be needed to explain why figures differ between countries. For example, he said some countries do a lot of research to seek out cases of likely non-compliance before approaching companies, while others preferred to make spot checks. The data for these different approaches would probably show much higher success rates in the first case compared to the latter.

Mats Forkman, head of unit enforcement and registries at the Swedish Chemicals Agency (Kemi), said measuring the number of inspections carried out by a national enforcement authority would not necessarily show the true picture and effectiveness of the work carried out. For example, he asked, how the indicators would distinguish between inspections of “a distributor selling truckloads of chemicals … and a small newsagent.

“We want to ensure a good outcome, which is a high level of [protection for] human health and the environment. It is not about ensuring a high number of inspections. It could help but I have some concern that the numbers [set out in the indicator] will take over.”

UK Health and Safety Executive inspector Mike Potts said the indicators are “helpful”, particularly because inspectors in the UK have to report to their managers about how they conduct their work. However, he agreed there are concerns around using inspection numbers as an indicator, and that it was “important that we are clear on what those numbers mean. If I carry out 100 poor inspections or 20 good inspections – which is better?”

He said people should be aware of “exactly what the numbers mean” and not to view them as a league table.

Mr Aguado-Monsonet said that by collecting and using similar data to evaluate enforcement, the indicators aim to provide a better knowledge of REACH and CLP enforcement, and contribute to a more harmonised approach across the EU.

He said the preliminary results showed that work still needs to be done to ensure the results are robust, and further discussions are needed with the Forum, member states and within the Commission regarding the interpretation of the results.

The final results are expected to be used in the 2017 review of REACH. »

rapport2


Sources:
Article of Emma Chynoweth and Leigh Stringer
https://chemicalwatch.com/43157/eu-makes-progress-on-reach-enforcement-indicators
http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8280&lang=en
Indicators report : ec.europa.eu/DocsRoom/documents/10364/attachments/1/translations/en/renditions/n

Cet article n’engage que son auteur/ This article is the sole responsibility of the author

ECHA Says BoA Sonc Decision is Case- Specific

« Agency plans to inform registrants of dossier evaluation outcomes next year.

ECHA says it considers that a decision by its Board of Appeal (BoA), regarding a statement of non-compliance (Sonc), following a dossier evaluation decision, only applies to the specific case between the appellant and itself.

In its decision on the case – finalised in August– the BoA said the agency should have followed the decision-making procedures outlined in REACH Articles 50 and 51 when issuing the Sonc. This enables the registrant to comment before the Sonc is issued.

Speaking at Chemical Watch’s Global Enforcement Summit in Brussels, Ofelia Bercaru, head of unit in Echa’s directorate of evaluation said: “We don’t see reason to withdraw other Soncs.”

She said the agency considered the case was particular as it applied to a notified new substance (Nons) dossier submitted originally to the Belgian authorities under legislation preceding REACH.

However, she added that the agency plans to initiate a discussion with the Competent Authorities for REACH and CLP (Caracal) and the Enforcement Forum. This will be to see whether adjustments are needed to the Sonc step within the dossier evaluation process.

Ms Bercaru said the REACH evaluation process seems to work well. She noted that out of the 600-plus dossiers evaluated so far, around 80% achieved compliance based on the evaluation decision. A further 10% had become compliant after a Sonc had been issued. Some 56 Soncs are pending.

Ms Bercaru said registrants have the opportunity to comment to Echa during the dossier evaluation decision-making. And many do, to discuss issues such as:

  • deadlines;
  • progress on testing; and
  • requesting advice.

However, once a decision is issued, she said, Echa cannot modify it, adding: ”If [the registrant] is not happy, it can submit an appeal.”

She added that a Sonc is a way of transferring authority to the national bodies responsible for enforcement. Echa does not have the competence for enforcement. “A Sonc is a way to put everyone on an equal footing on the same information,” she said.

Meanwhile, Echa is planning to inform registrants on the outcome of the follow-up to dossier evaluation from next year. Some companies have asked to know if their dossiers have successfully completed this follow-up process. Ms Bercaru said that Echa will send out a statement. But, she added, this would not mean another compliance check cannot be started on another issue. »


Source:
https://chemicalwatch.com/43146/echa-says-boa-sonc-decision-is-case-specific

Cet article n’engage que son auteur/ This article is the sole responsibility of the author.

ECHA Forum Prepares Restriction Enforcement Tools

« Compendium of analytical methods, guidance on results interpretation to be published.

Echa’s Enforcement Forum is preparing several guidance documents and tools, to help national enforcement authorities and companies assess whether articles comply with REACH substance restrictions.

The area has been fraught with difficulties, for many years, because of the lack of officially recognised test methods for checking if a material meets the concentration limits and migration levels set in REACH restrictions, and other regulatory instruments.

This means different laboratories use different analytical methods, while varying sampling methods can also contribute to a wide disparity in test results.

However, the first edition of a compendium of analytical methods is due to be published on Echa’s website by the end of the year, according to Enforcement Forum member, Maria Letizia Polci.

Speaking today at Chemical Watch’s Enforcement Summit, Ms Polci, who works on REACH enforcement for Italy’s health ministry, said the compendium will include 138 recommended methods for 41 restriction entries, and that the forum will invite interested parties to submit additional information for future editions.

Another challenge for enforcement authorities, she said, includes the broad scope of restrictions, which may cover a large number of mixtures and articles.

The forum is also developing guidance on the interpretation of analysis results and hopes to publish information in 2017. This will be on the lessons learned from next year’s Ref-4 coordinated enforcement project on restrictions.

Meanwhile, the European Standards Organisation (CEN) will develop analytical methods for determining the lead and polycyclic aromatic hydrocarbons (PAHs) content, and migration levels, in consumer articles and for chromium compounds in leather goods. Future annual CEN work programmes will include other analytical methods, said Ms Polci.

In addition, the European Commission’s taxation and customs directorate, DG Taxud, is drawing up a correlation table, which will list the mixtures and articles, which may contain a restricted substance, together with the appropriate CN or Taric codes. The Commission will create such codes, for articles without them. »


Source:
Article of Geraint Roberts
https://chemicalwatch.com/43116/echa-forum-prepares-restriction-enforcement-tools

Cet article n’engage que son auteur/ This article is the sole responsibility of the author.

German Environment Ministry Outlines REACH Priorities

« Top official says ‘protect’ it from TTIP, improve dossier quality.
The environment ministry of Europe’s biggest member state has spelled out its priorities for protecting the achievements of REACH, and improving its implementation.

Speaking at yesterday’s conference in Brussels on the future of REACH, organised by nine European countries, Alexander Nies, deputy general of Germany’s federal environment ministry (BMUB), said European governments must “protect” the hazard-based elements of REACH, and its placing of the burden of proof of chemical safety on industry, from TTIP, the current EU-US talks on a new trade agreement.

His comments were echoed by Monique Goyens, head of European consumers group Beuc, who described TTIP and the European Commission’s Better Regulation programme as a “toxic cocktail” that threatens to “further delay regulation on chemicals in Europe”.

In contrast, Cefic director general Hubert Mandery called for increased cooperation with the US on chemicals, through the TTIP talks.

The BMUB is also concerned about the quality of registration dossiers, said Mr Nies, especially for endpoints such as reproductive and developmental toxicity. “Standard animal testing is the exception. But the alternative information provided is insufficient, in many cases, for most high tonnage substances,” he said.

Echa must “intensify” its dossier compliance checks and target the most important endpoints. It must also “communicate more clearly the extent to which animal testing is indispensable”, even though “this is an uncomfortable message – industry doesn’t like it, and the animal welfare NGOs certainly don’t like it.”

On authorisation, Mr Nies said that although the process was broadly working, discussion of possible changes was needed. The weighing of the economic benefits and risks of a particular use of a substance, he said, is a political task, not a scientific one, and is, therefore, not a task for Echa.

As well as registration dossier quality, a number of common themes were raised by most of the conference speakers. These included how to: help the substitution of SVHCs; weigh the need to increase material recycling against the need to restrict SVHCs and other hazardous substances; move forward on nanomaterials and endocrine disruptors; and make REACH work better for SMEs and downstream users.

An issue mentioned by competent authorities, industry and NGOs was the need to remove the competitive disadvantage faced by companies in Europe, regarding banned substances in articles. The problem is twofold: imported articles, containing restricted substances, are still appearing on the EU market; and the phase out of Annex XIV substances does not apply to imported articles.

Germany’s Environmental Protection Agency (UBA) says it would be legally possible for the EU to extend the applicability of Annex XIV to imported articles, without infringing free trade law. »

cefic


Sources:
Article of Geraint Roberts
https://chemicalwatch.com/43113/german-environment-ministry-outlines-reach-priorities
Cefic press release : http://www.cefic.org/newsroom/top-story/TopStories/REACH-legislation-beyond-2018/
Cefic Director General Hubert Mandery’s presentation : http://www.cefic.org/Documents/Media%20Center/News/REACH-and-beyond-conference-20October2015-Hubert-Mandery-Presentation.pdf

Cet article n’engage que son auteur/ This article is the sole responsibility of the author.

« ECHA Must Take a Stand On Compliance’

« Following the REACH “no data, no market” principle, a chemical is only allowed on the market, once manufacturers and importers register the substance and prove it is safe by submitting specific information.

Competent authorities will only be able to regulate chemicals effectively, when they have a clear picture of what’s on the market – and this can only be established through information provided by companies. This information would also better inform citizens about the chemicals they are exposed to.

Registration dossiers are, therefore, the pillar of REACH and this is why it is so crucial that the information provided is accurate, adequate, reliable, relevant and trustworthy.

However, the quality of registration dossiers is embarrassingly poor. According to Echa, 69 % are not even in compliance. The main problems are with the identification of the substance and the waivers or justifications given for not submitting studies or parts of the safety report. This is fundamental information to ensure substance safety.

In order to help companies to improve the quality of the registration dossiers, Echa, since 2009, has launched a very varied bunch of soft measures, such as quality observation letters, informal contact with companies, targeted letter campaigns, lists of substances that are likely to face compliance checks, REACH guidance updates, more streamlined and concise advice and statements of non-compliance (Soncs).

Nevertheless, despite the agency’s efforts, compliance has not improved at all. The percentage of non-compliant dossiers has remained well over 50 % for the last five years as demonstrated in the following figures:

in 2009 – 50 %;

in 2010 – 64 %;

in 2011 – 92 %;

in 2012 – 67 %; and

in 2014 and 2015 – 69 %.

Moreover, the German Federal Institute for Risk Assessment (BfR) released a study, this year on data availability in REACH registrations that showed only one dossier, out of 1,814, was compliant with standard information for all endpoints.

It is evident that the soft measures applied by Echa are highly ineffective. Not only is there a lack of incentives to ensure compliance, there are too many encouraging the opposite, such as the lack of regulatory action and the low chance that a dossier will be evaluated – under REACH, Echa has been required to examine 5% of registration dossiers for the first two deadlines.

It’s time to move on from soft measures, guidance and advice to getting serious about enforcing compliance.

We propose that Echa:

*does not grant registration numbers, in the first place, for empty dossiers or dossiers with inadequate information, such as insufficient description of a substance identity. More manually examined dossiers and fewer automated completeness checks, that don’t evaluate how adequate the information, are needed;

*completeness checks, performed for the whole registration dossier, including chemical safety reports;

*exclude from the market, by cancellation of registration numbers, those substances where safety has not been proven (for example, if the compliance check shows very bad quality dossiers or the dossier is not complete) in order to ensure a level playing field that favours companies taking REACH seriously. Although Echa agreed it may invalidate registration numbers in well-justified cases a few years ago, revocation has only been considered in cases where registration numbers were assigned to non-existent registrants, and where they failed to pay the correct registration fee. However, there are some “good cases”, such as the ongoing Board of Appeal case where an almost empty dossier was accepted by Echa;

*apply a “naming and shaming” mechanism, such as disseminating the names of non-compliant companies, or a traffic light system for the dossiers that pass an evaluation in the dissemination portal. These mechanisms would be a very good incentive to compliance as both market access and reputation are very important for companies. Moreover, it would ensure informed decisions by citizens, increase market pressure and protect human health and environment; and

*increase the compliance checks rate beyond 5 % of registration dossiers.

After eight years, the compliance problem is no different; two thirds of the information provided by companies under REACH is not reliable or compliant, putting the credibility of the process at stake and blocking any protective action by competent authorities.

The compliance checks process is the most important measure to improve the quality of dossiers but Echa is seen as very weak by most registrant companies, which are doing nothing to improve their dossiers.

A more ambitious approach by the agency, that gives fewer carrots and more sticks to non-compliant companies in order to ensure full compliance with the legal text, should be by hook or by crook the minimum. »


Source:
Article of Tatiana Santos, senior chemicals and nanotechnology policy officer, EEB
https://chemicalwatch.com/43069/echa-must-take-a-stand-on-compliance

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