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Benefit from a faster processing of your REACH dossier

Benefit from a faster processing of your REACH dossier

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.

Further info
https://echa.europa.eu/sk/-/benefit-from-a-faster-processing-of-your-reach-dossier

EU and industry directors recommend actions to help SME registrants

EU and industry directors recommend actions to help SME registrants

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Further info
https://echa.europa.eu/sk/-/eu-and-industry-directors-recommend-actions-to-help-sme-registrants

First opinions on Union authorisation adopted

First opinions on Union authorisation adopted

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.

Further info
https://echa.europa.eu/sk/-/first-opinions-on-union-authorisation-adopted

IUCLID Cloud now guides you through dossier preparation

IUCLID Cloud now guides you through dossier preparation

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.

Further info
https://echa.europa.eu/sk/-/iuclid-cloud-now-guides-your-dossier-preparation


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