Scientific criteria have been agreed to identify endocrine disruptors under the EU legislation for pesticides and biocides. The criteria for biocides apply from 7 June 2018.
Helsinki, 7 June 2018 – A drafting group consisting of scientific staff from ECHA and the European Food Safety Authority (EFSA), with the support of the Joint Research Centre (JRC), have developed scientific guidance to enable the identification of endocrine disruptors. The guidance advises applicants and assessors of the competent regulatory authorities on how to identify endocrine disruptors in accordance with the endocrine disruptor criteria.
The European Commission tasked ECHA and EFSA to develop the guidance to ensure harmonised implementation of the endocrine disruptor criteria throughout the EU for the assessment of biocides and plant protection products. The guidance has been consulted with the Agencies’ stakeholders, ECHA’s endocrine disruptor expert group and Member States’ biocides and pesticides competent authorities.
ECHA will host a webinar on 19 June to explain the practical implications of the criteria and the new guidance to the affected companies and authorities with obligations under the Biocidal Products Regulation.
The European Commission is preparing to amend the Authorisation List (Annex XIV to REACH) entries owing to the additional identification of the four phthalates as substances of very high concern (SVHCs) with endocrine disrupting effects on human health or the environment. Consequently, some uses previously exempted may require authorisation.
Helsinki, 5 June 2018 – In 2014 and 2017 the four phthalates bis(2-ethylhexyl) phthalate (DEHP, EC 204-211-0, CAS 117-81-7), dibutyl phthalate (DBP, EC 201-557-4, CAS 84-74-2), benzyl butyl phthalate (BBP, EC 201-622-7, CAS 85-68-7) and diisobutyl phthalate (DIBP, EC 201-553-2, CAS 84-69-5) were identified as substances of very high concern (SVHCs) for authorisation due to endocrine disrupting properties with effects on human health and, in the case of DEHP, also on the environment. The Candidate List entries for these substances were updated accordingly.
The four phthalates had earlier been identified as SVHCs and subsequently added to the Authorisation List in 2011 and 2012 due to their classification as toxic for reproduction.
Later this year, the European Commission intends to amend the current entries of these substances in the Authorisation List to also include the endocrine disrupting properties as intrinsic properties referred to in Article 57.
The 10-year registration period for existing chemicals is now complete following the last REACH registration deadline on 31 May 2018. 13 620 European companies have submitted information to ECHA in nearly 90 000 registrations for chemicals manufactured in or imported to the EU and EEA at above one tonne a year.
Helsinki, 1 June 2018 – Today we know more about the chemicals used in Europe than ever before. This knowledge, generated by industry, is stored and published by ECHA in the world’s largest public regulatory database on chemicals and forms the basis for protecting citizens and the environment from the risks posed by chemicals. ECHA, the EU Member States and the European Commission will use the increased knowledge to take action where necessary, for example, by restricting or authorising certain uses of chemicals.
Over the first 10 years of the REACH Regulation, the EU has established a fair and transparent internal market for chemicals with strict safety rules. This promotes innovation towards safer substances and strengthens EU competitiveness.
During the last two weeks before the 31 May registration deadline, you can easily contact ECHA for help with your registration using a new live chat function.
Helsinki, 17 May 2018 – From Friday 18 May until Thursday 31 May, ECHA staff will be on call to help you register your substance successfully under REACH.
Give your name and email address and click Join now. You will be able to get assistance and answers to your questions from our panellist ‘ECHA Support 2018’.
We aim to answer you on the spot. If more time is needed to consider and provide information, we will let you know. ECHA’s support chat is available on weekdays from 9:00 to 16:00 CEST (GMT +2).
Summaries of product characteristics and non-confidential assessment reports will be available on ECHA’s website by the end of 2018.
Helsinki, 16 May 2018 – ECHA will make more information on biocidal products available on its website. There will also be more options for users to search for information, and it will be possible to compare products.
What will be published?
Non-confidential assessment reports by national authorities
Updates to the authorisation status of products (amendments, revisions and renewals)
Summaries of product characteristics, containing key product information, including:
product trade names
substances in the product and their concentrations
biocidal product composition
the manufacturer of the product
the manufacturer of the active substance
hazard and precautionary statements
the organism the product is targeted at
application methods
type of packaging
instructions for use.
What will remain confidential?
Information that can undermine the protection of the commercial interests or the privacy of the persons concerned. This includes details of the full composition of the product and the precise tonnage of the active substance or product manufactured or made available on the market.
The function of a non-active substance in a biocidal product can be considered confidential. The name of a non-active substance can also be considered confidential unless being aware of its existence is essential for the proper use of the product or the substance is of concern.
Next steps
To make sure the information will be correctly published, the Member State competent authorities for biocidal products are checking the assessment reports, summaries of product characteristics and decisions available in R4BP 3, the biocides IT tool. Before uploading an assessment report, they will contact the relevant companies directly to check what information should be kept confidential.
The work is planned to be finalised by the end of November 2018.
The cloud version of the chemical data management tool IUCLID – built with special features to support small and medium-sized companies (SMEs) – is now available to companies of all sizes.
Helsinki, 15 May 2018 – ECHA is opening the IUCLID Cloud for SMEs to all companies registering under REACH. The service was originally designed for SMEs and their consultants to help them in preparing their registration dossiers for the 31 May 2018 deadline by providing a simpler platform.
The Agency changed the terms of the service to support future registration activities, as companies will continue to submit updates of existing registrations and new dossiers. The cloud service will ease especially the preparation of small-volume REACH registrations.
The IUCLID Cloud fits your purpose best if:
you have to manage data for around 50 substances and the volume of data is low (does not exceed 1 GB);
you want to work online, with your IUCLID application always up-to-date;
you want to benefit from a simpler interface and get additional support through step-by-step guidance to prepare your dossier.
If you have already started preparing your REACH registration with the traditional IUCLID software, you can easily import your data to the cloud and continue your work online. Also, if at some point you want to use the traditional IUCLID again, you can export your data back.
To allow the service to be used by all companies, an update in the terms and conditions is required. This means that, after the update, current subscribers of IUCLID Cloud will have to accept again the (amended) terms and conditions.
Submit your REACH 2018 registration dossier before the end of March and receive ECHA’s decision on your registration within three weeks. If you make your submission in April or May, it may take up to three months for you to get ECHA’s decision.
Helsinki, 14 March 2018 – Companies that submit their registration dossier before the end of March will receive a decision on its completeness from ECHA within 21 days from the submission date. For dossiers submitted from 1 April onwards, it may take until the end of August 2018 to receive a decision. This longer period to check the completeness of submissions is set out in the REACH Regulation to give ECHA the necessary time to process the high number of registrations expected to arrive close to the 31 May 2018 deadline.
Before submitting your dossier, remember to run the Validation assistant in IUCLID both on your dataset and dossier to make sure that you have all the required information. Submit your dossier only once the Validation assistant shows that you do not have any failures. However, if the Validation assistant does not indicate any failures, it does not automatically mean that your dossier is complete. ECHA staff may check some parts of your dossier manually and these completeness checks cannot be replicated with the Validation assistant. Have a look at the available help to get familiar with these manual checks.
If you are a lead registrant, keep in mind that you should submit your dossier early enough to allow time for the member registrants to submit their company-specific dossiers by the 31 May 2018 deadline.
To support you in your preparations, from 16 March onwards ECHA will keep the dossier submission and communication tool REACH-IT open 24 hours a day, seven days a week. The tool might be closed on Monday mornings from 7:00 to 10:00 EET (Helsinki time) for scheduled maintenance. Support through ECHA’s Helpdesk is available during ECHA’s business hours as usual.
The Directors’ Contact Group (DCG) recommends four actions to ease the cost burden on first-time registrants for accessing data and the joint submission for their REACH 2018 registration.
Helsinki, 20 December 2017 – The DCG – a platform of the European Commission, ECHA and industry associations – continued its discussions on 15 December on how to best help SME registrants that face significant expenditure ahead of the 31 May 2018 registration deadline. The DCG recommends four actions for companies and ECHA to allow small-volume or SME registrants that have not registered substances before to access data and the joint submission with reasonable effort.
These actions are:
Reducing the costs of data for 1-10 tonne registrants by exploring data waiving arguments: Companies should check whether they are exempted from providing (eco)toxicological data with their small-volume registration and could register only with physicochemical data. These exemptions relate to Articles 12(1)(a) and (b) and Annex III of REACH. Those who can register with physicochemical data only, should get access to the data and joint submission at reduced or no costs.
Addressing situations caused by late data-sharing negotiations or pending dispute decisions: The DCG recommends that first-time registrants file a data-sharing dispute with ECHA if the negotiations for access to data have come to a standstill and all means to reach an agreement have been exhausted. Companies will be able to submit their registration dossier while the negotiations or the dispute process are ongoing. ECHA will clarify how it will deal with these dossiers by the end of January 2018.
Reducing the cost burden on SMEs by allowing payment in instalments: If a one-time payment of the letter of access (LoA) is unaffordable for the first-time registrant – and they can justify why – lead registrants and the managers of the substance information exchange fora (SIEF) should consider granting the registrant the opportunity to pay in instalments.
Offering a low-cost affordable lump sum payment option for 1-10 tonne registrants: Lead registrants and SIEF managers can reduce the administrative burden of joining an existing joint submission and the risk of a data-sharing dispute by offering first-time registrants the opportunity to make an affordable lump sum payment. The recommendation also provides circumstances and conditions that facilitate lump sum charging.
The DCG recommendation only concerns access to existing data for registering substances by the May 2018 deadline. It will not apply to sharing the costs of creating new data or providing information, for example, in response to ECHA’s substance evaluation decision.
In addition, the DCG decided to open four solutions designed already for the 2010 and 2013 deadlines for companies in exceptional circumstances (solutions 10, 15, 20 and 21). These will be available for the 2018 registrants from 31 January 2018 onwards. It also decided to slightly amend the wording of solutions 15 and 21.
On 31 January 2018, ECHA holds its REACH 2018 Stakeholders’ Day where first-time registrants get advice from ECHA and industry experts and can ask questions from ECHA staff.
The Biocidal Products Committee (BPC) adopted its first opinions supporting applications for Union authorisation for two products. The Committee also adopted opinions on six active substances for use in disinfectants, preservatives and pest control.
Helsinki, 20 December 2017 – The Committee supported applications for EU-wide access to the market for two biocidal product families containing iodine/PVP-iodine for use in veterinary hygiene.
The Committee concluded on applications for the following active substances in disinfectants, preservatives and pest control products:
cyphenothrin for product-type 18
penflufen for product-type 8
acetamiprid for product-type 18
cholecalciferol for product-type 14
formaldehyde for product-type 2
empenthrin for product-type 18.
The Committee supports the approval of cyphenothrin in product-type 18, penflufen in product-type 8 and acetamiprid in product-type 18.
For cholecalciferol, the Committee concluded that it can be considered as having endocrine-disrupting properties.
For formaldehyde, the Committee proposed that it is approved for product-type 2.
For empenthrin, the Committee concluded that it may not be approved for product-type 18.
The Committee also adopted several opinions addressing requests from the Commission.
For the first time, an opinion was given to support the Commission in addressing an unresolved disagreement between Member States during the mutual recognition of insect repellent biocidal products.
The Committee concluded that copper sulphate does not act as an active substance in the product that was considered.
The Committee concluded that powdered corn cob is eligible for inclusion in Annex I (list of substances that do not give rise to concern).
Among the substances eligible for inclusion in the review programme which benefitted from a derogation for food and feed (Article 6 of the Review Programme Regulation), the Committee concluded that cheese, concentrated apple juice, d-fructose, honey, powdered egg, yeast (saccharomyces cerevisae) and vinegar are eligible for inclusion in Annex I.
The adopted opinions will serve as a basis for final decision making by the European Commission and the Member States.
The Committee met for the 23rd time from 11 to 14 December 2017.
An update of the cloud version of IUCLID is now available. The tool now provides step-by-step guidance on how to build a complete REACH registration dossier for the REACH 2018 deadline.
Helsinki, 19 December 2017 – With IUCLID Cloud, you can prepare your REACH registration dossier directly online without the need for local software installation. In the latest release of IUCLID Cloud, a step-by-step guide for preparing your REACH 2018 IUCLID dossier will walk you through creating a full dossier from scratch. With this feature, you will be able to carry out a series of well-defined tasks for the type of dossier you intend to submit to ECHA. A tailored help – translated into 22 EU languages in early 2018 – guides you through each of the tasks.
You no longer need to be an expert IUCLID user to prepare your dossier in time for the upcoming registration deadline at the end of May 2018.
The release also offers additional features that help you with your tasks. You will be able to:
check your dataset with the Validation Assistant;
see what information from your dossier will be published on ECHA’s website;
automatically generate your chemical safety report;
push your dossier for submission and retrieve it directly from REACH-IT to complete your submission; and
access specific help texts for each task you need to perform.
This third major release of the IUCLID Cloud services follows the releases of the IUCLID Cloud Trial in April and the IUCLID Cloud for SMEs in July 2017. ECHA has developed the cloud services specifically for SMEs and their consultants to help them prepare for the 31 May 2018 registration deadline. The IUCLID Cloud interface is simpler than the one of the traditional IUCLID software, which makes it easier to use and fit for purpose for the registration of chemicals in tonnage band of 1 to 100 tonnes per year.
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