REACH24H Consulting Group

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The European Chemicals Agency (ECHA) has just released a notification for companies that are interested in submitting their REACH dossier in the face of its current May 31st 2018 deadline. Companies that submit their dossiers before the end of March will receive ECHA’s decision on the registration within three weeks of filing. The agency is expecting high levels of submissions in the months of April and May, thus companies filing REACH dossiers over these later months may need to wait up to three months to receive ECHA’s decision.

In order for a dossier to be submitted, it must first be uploaded in REACH-IT, and then it must successfully pass completeness check. As the completeness check carried out by ECHA staff not follow a prescribed time, REACH24H strongly recommends its clients to submit their REACH dossiers if possible before March 31st. This should provide sufficient time to receive a registration number before the deadline. In the event they are unable to submit the REACH dossier before March 31st, it is not possible to ascertain a registration number may be obtained by the set deadline.

Still, companies need ultimately only ensure their dossiers are successfully submitted within the prescribed May 31st 2018 deadline to be allowed to trade in the EU.

To access the official ECHA news release, please click:

Benefit from a faster processing of your REACH dossier

ECHA Q&A

Published in EU REACH NEWS

Following the UK’s decision to withdraw from the EU, ECHA has released a number of recommendations to UK and EU-based companies operating with the REACH Regulation in the hopes of assisting them through the changing political landscape.

• Until the UK withdrawal from the EU takes effect on 30 March 2019, all UK-based companies interested in registering phase-in and non phase-in substances must comply with the provisions of the REACH Regulation, including the 2018 registration deadline. Following said date, companies are advised to follow legislative developments on domestic registration obligations in close detail.

The registration of any substances by UK-based companies after 30 March 2019 will be disregarded, as they will be considered to be based in a “third country” outside the EU/EEA. Therefore, EU/EEA customers will have to register the substances themselves. Provided a manufacturer that has already registered substances wishes to continue supplying to EU-27/EAA customers based on its own registration, it may relocate to the EU-27/EAA or designate an Only Representative within said territory. UK-based importers from non- EU-27/EAA countries will have the option to relocate to the EU to continue supplying to their EU customers.

For UK-based companies acting as Only Representatives of non-EU manufacturers, manufacturers must have an Only Representative based in one of the EU-27/EAA countries by the time of the UK withdrawal. This change will have to be registered in REACH-IT.
ECHA will charge the corresponding fee for any UK-based company that, in view of the UK withdrawal from the EU, transfers its REACH registrations or if the Only Representative status is changed to one based in the EU-27.

Following the UK withdrawal date, the UK will no longer be bound by EU legislation. Therefore, UK-based companies with ECHA registered substances will no longer have to provide updates on their dossiers.

When registering substances of very high concern (SVHC), provided the specific sunset date follows the UK withdrawal date, the company will at that point acquire a non-EU status, and it will no longer be bound by the REACH Regulation. Therefore, an application for a REACH Authorisation will no longer be necessary. In the event any EU-27-based importer of the substance and/or downstream consumer intends to use said substance in the EU, they may be required to apply for the REACH Authorisation.

UK-based companies acting as downstream users of substances covered by a REACH Authorisation issued in accordance with Article 56 (2) will no longer be bound by it. Consequently, they will no longer be required to keep their UK and EU-27 suppliers nor ECHA informed of the uses of the substances.

For any EU-27-based company purchasing chemical substances registered under REACH which belong to a UK-based partner, the company will have to relocate or appoint an Only Representative within the EU-27 for the substance to remain legally valid and continue registered with the ECHA for the EU-27/EAA. Otherwise, the EU-27-based company will have to register the substance as an importer.

For EU-27 companies that are registrants in a joint submission where a UK-based company is the lead registrant and the owner of the data, ECHA has indicated the lead registrant should move to a EU-27 country or apply to change its status to become a EU-27 Only Representative prior to the date of the UK withdrawal to ensure they continue to benefit from the joint submission. Alternatively, a new lead registrant may be appointed. In this case, duties should be transferred before the withdrawal date and provisions will be included in the Agreement to manage the change of lead registrants and secure the transfer of duties, shared information, etc.

Following the UK withdraws from the EU, REACH Authorisations granted to UK-based supplier will lose effect. Therefore, any EU-27 company that uses a substance based on such an Authorisation should ensure one of its EU-based upstream suppliers or itself holds such a document to ensure the use of the chemical substance within the EU.

Finally, while the Community Rolling Action Plan (CoRAP) 2012-2014 and its updates had delegated specific review duties associated to the REACH evaluation process to UK public authorities, provisions are being made to reassign these duties to another Member State.

Published in EU REACH NEWS

According to the news released on April 8, 2016 by ECHA, over 8000 REACH registration dossiers in total will be reopened for completeness checks to uphold the “one substance, one registration” principle. The first set will be the 118 charcoal dossiers, following the decision of last month’s Board of Appeal ruling. ECHA will also recheck all dossiers which may be in breach of the joint registration principle of REACH. This means that approximately 700 individual registrations submitted under the REACH Regulation will be reopened, representing 1.5% of all registrations. At the same time, ECHA will recheck the completeness of the dossiers in its database with regard to the information requirements to verify that the information provided is meaningful. It is highly suggested that companies registered individually keep close contact with their OR.

ECHA suggests that companies check the relevance of the information that they have submitted and make sure that the ‘one substance, one registration' principle is followed. They are encouraged to proactively update their registrations as soon as possible if needed. If a dossier is found to be incomplete after the retroactive completeness check, the registrant will be given a reasonable amount of time to update their dossier with the missing information. If they provide the information within the deadline and fulfil the joint submission obligation, they can remain on the market without interruption. Otherwise, the registration will lose its validity and the company will lose market access.

Also, an enhanced automated completeness check will be available later this year with the launch of the new version of REACH-IT. But a manual verification of certain data elements that cannot be checked automatically is still needed, which will prevent registrants from misusing the system by adding irrelevant information to bypass an information requirement, for new submissions and for updates of an existing registration.

The news also mentions that ECHA's Helpdesk will assist companies intending to join the joint submission or share data. If the negotiations for sharing data and joining a joint submission fail after every effort to reach an agreement has been made, registrants can file a data-sharing dispute to ECHA free-of-charge.

The upcoming move of completeness checks to be taken by ECHA is in line with the new implementing regulation to clarify the “fair, transparent and non-discriminatory” principles for data sharing under EU REACH, which came into force on 26 January, 2016, which gives ECHA the mandate to champion the “one substance, one registration” principle in the REACH regulation. Meanwhile, ECHA took into consideration various uncertainties and provided registrants with a means to solve disputes.

To properly deal with the upcoming checks, REACH24H suggests that:

1. For substances with available joint registration, REACH24H suggest potential registrants to get a clear understanding of cost sharing for the required data and communicate actively with the Lead Registrant( LR). For unreasonable cost sharing practices, potential registrants could appeal to ECHA.

2. For substances without joint submission dossiers, REACH24H suggest potential registrants to play the role of LR and take the initiative to set rules for cost sharing.

If you’re interested in more details about this topic, please send your queries directly to rscchelp@reach24h.com .

Source:

ECHA to review completeness of registrations

Published in EU REACH NEWS

On 6 January, the European Commission adopted a new implementing regulation to clarify the “fair, transparent and non-discriminatory” principles for data sharing under EU REACH, which came into force on 26 January, 2016. It gives ECHA the mandate to champion the “one substance, one registration” principle in the REACH regulation.

To implement this requirement, the dossier submission tool REACH-IT had been adapted to reject submissions outside of a joint registration after a maintenance break before 27 January. This indicates that potential registrants are no longer entitled to submit dossiers individually even if a long-term negotiation was inevitable without a consensus in cost sharing.

REACH24H advises potential registrants to get a good understanding of the registration status beforehand and pay attention to the following situations:

• There can be two joint registration dossiers for one substance as a result of varied data requirements for differentiated uses as a substance or an intermediate.

• If there has been a joint registration dossier for one substance, then potential registrants can no longer submit the same type of registration individually.

• If a registration dossier has been submitted individually, then relevant information could not be updated until being part of a joint registration to ensure the validity of the registration number.

• A joint registration could still be possible regardless of individual registrations successfully submitted previously.

Besides, ECHA clarifies on possible disputes in data sharing. For example, if there are disagreements about the selection of data, an opt-out for those data points is possible and registrants can still submit their own data. This means a cost reduction is possible on the one hand and a joint registration can still be realized on the other hand. ECHA encourages a friendly negotiation among all members to solve problems appropriately in data sharing and provides means for appeal when disputes occur.

The recent adaption of the REACH-IT indicates that ECHA pays more attention to the feasibility of implementation when updating the dossier submission tool and tries to avoid unnecessary disputes by means of optimized management. ECHA spares no efforts to implement the principle of “one substance, one dossier”, indicating that potential registrants must try to reach an agreement with registered companies in terms of substance sameness and cost sharing. If disputes exist in cost sharing, potential registrants joining a SIEF can request a breakdown of the study and administrative costs that make up the price for the joint registration. If disputes still exist, potential registrants can turn to ECHA for help.

Here are some advices by REACH24H for compliance with the new implementing regulation:

1. For substances with available joint registration, REACH24H suggest potential registrants to get a clear understanding of cost sharing for the required data and communicate actively with the Lead Registrant( LR). For unreasonable cost sharing practices, potential registrants could appeal to ECHA.

2. For substances without joint submission dossiers, REACH24H suggest potential registrants to play the role of LR and take the initiative to set rules for cost sharing.

If you’re interested in more details about this topic, please send your queries directly to rscchelp@reach24h.com .

Published in EU REACH NEWS

The European Chemical Agency (ECHA) is expected to release the Annual Evaluation Report 2015 in the forthcoming February. In 2015, ECHA has adopted new strategies for dossier compliance check, with special attention paid to substances that exert the largest impact on environmental and human health.

Given the increasingly frequent and strict evaluation activities taken by ECHA and its member states, REACH24H Consulting Group as the Only Representative (OR) of many non-EU companies has consistently represented the interests of our clients seeking for constructive communication with competent authorities and responded to multiple evaluation decisions and enforcement checks properly. It is worth noting that the post-registration compliance work can never be well accomplished without the cooperation of non-EU companies. In this article, REACH24H elaborates on ways for post registration compliance to address your concerns.

1. How to use the registration number by non-EU companies?

Please visit our NEWRSCC compliance platform to download the Submission Report issued by ECHA and the Confirmation Letter prepared by REACH24H when the registration number is available. Make sure that the contents of the Confirmation Letter are correct and remember to apply for a REACH Tonnage Coverage Certificate (TCC) at the NEWRSWCC platform each time when a deal is made. Confirm if you are obliged to pass the SDS or eSDS to downstream users. Besides, it is always necessary to maintain a good communication between OR and importers and follow closely any updates concerning this substance under EU REACH.

2. What are the possible official moves after the completion of registration?

The two possible moves taken by ECHA or member states after the completion of registration are evaluation and compliance check. There are two types of evaluation, including dossier evaluation and substance evaluation. ECHA evaluates the information submitted by companies to examine the quality of the registration dossiers and the testing proposals and to clarify if a given substance constitutes a risk to human health or the environment. If the substance is considered as possibly posing potential risks and dangers, then a Member State will designated to conduct substance evaluation and examine if it constitutes a risk to human health or the environment.

Compliance checks mainly involve specific importers. Competent authorities of the importing countries evaluate the substance identity description and the safety information in the dossier including the chemical safety report or specific parts of the dossier.

Please note that if you receive any decisions after substance evaluation or compliance check, a timely reply before the official deadline is a must, otherwise the registration number can be invalid.

Evaluation Process

3. Are your substances subject to evaluation?

1) Dossier evaluation. ECHA may examine any registration dossier to verify if the information submitted by registrants is compliant with the legal requirements. Dossier selection for compliance check is either random or concern based (targeted). According to the new strategies taken by ECHA in 2015, priority has been given to substances of high risks, including two categories: one is substances registered at high tonnage band with many data gaps and the other is substances with high exposure to workers, customers and the environment.

2) Substance evaluation. Member States evaluate certain substances to clarify whether their use poses a risk to human health or the environment. The selected substances are listed by ECHA in the community rolling action plan (CoRAP) following the opinion of the Member State Committee. An evaluating Member State will be designated for each substance on the final CoRAP. Listed in the CoRAP are mostly Environment/Suspected PBT and Human Health/CMR substances.

4. What are the focuses of inspections carried out by Member States?

Based on the practical experiences of dealing with inspections by the Health and Safety Authority (HSA), the lead Competent and Enforcement Authority for REACH in Ireland, REACH24H concluded the following major concerns:

  • Substance and tonnage band information corresponding to the registration number.
  • Signed Power of Attorney.
  • Tonnage coverage records by importers.
  • Safety Data Sheet management.
  • Intermediate and exemption validity.

Please refer to the previous article written by REACH24H for more information:

Analysis of the Final Report on the Third REACH-EN-FORCE Project: Advice on REACH Supply Chain Compliance

According to the news released by ECHA on 26 June, a fifth coordinated enforcement project (REF-5) will be prepared and executed focusing on obligations related to extended safety data sheets (e-SDSs), exposure scenarios, risk management measures and operational conditions, indicating that inspections may be carried out in a more strict manner.

5. What to do after receiving the registration documentation from OR?

REACH24H follows closely any evaluation or inspection decisions passed by ECHA, the Member States and LR and delivers such important information to you in the form of a SIEF report. The decisions issued are more often than not lengthy and complicated, involving hazardous information of the substance, regulatory requirements and the provisional basis of the decision etc. The decisions can be English documents including tens of or even hundreds of pages. To help you understand the decision well, REACH24H experts will formulate a SIEF report on the decision based on our regulatory compliance experiences and professional expertise to facilitate a cost-effective way for compliance.

Here is a typical case successfully handled by REACH24H. After the registration of furfuryl alcohol in 2013, REACH24H has been in close contact with the LR. As this substance potentially constitutes risks of carcinogenicity and toxicity, the Poland competent authority issued a decision for substance evaluation of this substance. The LR organized over 10 teleconferences or on-site meetings to discuss coping strategies and proposed the establishment of an international Furfuryl Alcohol consortium to address the regulatory issues. After a detailed analysis of the coping strategies of LR with the actual uses and risk control measures of downstream users well taken into consideration, REACH24H concluded that it was not necessary to join the consortium and helped our clients avoid follow-up sharing of testing costs.

Please read carefully the SIEF report sent to you by REACH24H, which will help you a lot in working out compliance strategies. If the product receiving decisions is pivotal to your trade in the EU market, you can be rest assured that we are always readily to help you communicate with the authorities or LR representing your interests.

Strict regulation has been taken over chemicals imported to the EU market in line with EU REACH to protect human health and environmental safety. Registration is just a first step to open the EU market. Companies need to cooperate actively when official evaluation and inspections are carried out. REACH24H is well positioned to help you get access to and secure a good place in the EU market at the prerequisite of compliance with EU REACH.

If you’re interested in more details about this topic, please send your queries directly to rscchelp@reach24h.com .

Published in EU REACH NEWS

With the deepening of market globalization, trade barrier inevitably becomes a common phenomenon. In the chemical industry, the EU REACH regulation has long been perceived by many as a kind of technical trade barrier. Companies have learned a lot in their efforts for completing registration within the previous two grace periods for substances at tonnage band of over 1000 t/a or 100-1000 t/a. As the last deadline of 31 May, 2018 for REACH registration comes close, the European Chemicals Agency (ECHA) has taken several steps to facilitate joint registration before 2018. On the one hand, relevant provisions and data requirements have been updated. On the other hand, enforcement actions have been taken by ECHA to secure compliance in REACH registration, OR obligation, eSDS and risk management measures etc.

At such a time of bidding farewell to the past while ushering in the new, REACH24H Consulting Group helps you connect the dots and grasp the highlights, well positioned to facilitate a comprehensive understanding of key developments of EU REACH in 2015.

As a far-reaching regulation, EU REACH replaced the previous multiple regulations, reduced conflicts between regulations in different countries and decreased compliance costs by companies. At the same time, the REACH regulation requires all roles in the supply chain to shoulder their due responsibilities to secure the safe use of chemical substances to protect human and environmental health. As the 2018 REACH registration deadline is just around the corner, REACH24H Consulting Group suggest that companies should follow closely important updates by ECHA and get well prepared.

Further Readings:

2015 Global Regulatory Highlights – Global GHS

2015 Global Regulatory Highlights – China Chemical Regulations

2015 Global Regulatory Highlights – South Korea Chemical Regulations

2015 Global Regulatory Highlights – Taiwan Chemical Regulations

2015 Global Regulatory Highlights – Japan Chemical Regulations


The year of 2015 saw a series of major regulatory changes, bringing both challenges and opportunities to the chemical industry. To tease out the key updates in Asia Pacific’s regulatory regime throughout the past year, ChemLinked has dedicated to prepare you an annual report “2015 Chemical Regulatory Review of the Asia Pacific Region”.

Published in EU REACH NEWS

As the last deadline of May 31, 2018 for REACH registration comes close, the European Chemicals Agency (ECHA) has taken several steps to facilitate joint registration before 2018. On the one hand, ECHA provides materials online to support registrants in their efforts for REACH compliance. On the other hand, much improvement has been made to the IT tools for better and efficient delivery of data.

Materials are being published by ECHA to help for the two phases of the REACH2018 Roadmap this year: phase 1 ‘Know your portfolio' was launched in June and the launch of phase 2 ‘Find your co-registrants' took place in November. ECHA will continue to create new support web pages next year and roll out phases 3 to 6 of the Roadmap.

Technically speaking, a “new generation” of IT tools to support REACH registration will be available next summer: IUCLID for creating dossiers; REACH-IT for submitting them; and Chesar for preparing chemical safety assessments. Notable changes to the customer interface and functionalities will also be realized. Registrants will see much more user-friendly tools than current ones.

Source: REACH 2018: the road ahead

Published in EU REACH NEWS

On August 31, 2015, seven substances proposed by ECHA, Germany, Austria and Sweden to be identified as Substances of Very High Concern (SVHC) have been approved and are soliciting public comments. The deadline for commenting is October 15, 2015. These 7 substances are proposed as SVHC because they can be carcinogenic, vPvB, PBT, toxic for reproduction and have probable serious effects to human health. If no objections arise from the public, the number of SVHC included in the Candidate List will increase from 163 to 170 by the end of this year.

Here below is the detailed information on the seven substances.

Name

EC NO.

CAS No.

Proposing Authority

Reason for Proposing

1,3-propanesultone

214-317-9

1120-71-4

ECHA

Carcinogenic (Article 57 a)

2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)

223-383-8

3864-99-1

Germany

vPvB (Article 57 e)

2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)

253-037-1

36437-37-3

Germany

vPvB (Article 57 e)

Dicyclohexyl phthalate

201-545-9

84-61-7

Sweden

Toxic for reproduction (Article 57 c); Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f)

hexamethylene diacrylate (hexane-1,6-diol diacrylate)

235-921-9

13048-33-4

Sweden

Equivalent level of concern having probable serious effects to human health (Article 57 f)

Nitrobenzene

202-716-0

98-95-3

Austria

Toxic for reproduction (Article 57 c)

Perfluorononan-1-oic acid (2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluorononanoic acid and its sodium and ammonium salts

206-801-3

375-95-1

21049-39-8

4149-60-4

Sweden

Toxic for reproduction (Article 57 c); PBT (Article 57 d)

Published in EU REACH NEWS

On 12 June 2015, ECHA’s Management Board has reduced the administrative charge for registrants that qualify for the EU definition of a micro, small or medium-sized (‘SME’) company, and came into force on 4 June 2015. From now, incorrect declaration of company size registrants can pay 2.5 times the financial gain (the difference between reduced SME fees incorrectly paid and the fees applicable to the correct company size category).

As we all know, SME companies can benefit from reduced fees under the REACH regulations. The reductions for micro, small and medium-sized enterprises are 10%, 40%, and 70% respectively. If registrants that fail to demonstrate their entitlement to the claimed reduced SME fees, are required to pay the correct fee as well as an administrative charge.

The revised scales of the administrative charge are presented in the following table:

Size of company

Administrative charge (€)

Large (non-SME)

If a large (non-SME) enterprise incorrectly claims to be an SME

19,900 or 2.5 times the financial gain*, whichever is lower

Medium

If a medium sized enterprise incorrectly claims to be a small or micro sized company

13,900 or 2.5 times the financial gain*, whichever is lower

Small

If a small enterprise incorrectly claims to be a micro sized company

7,960 or 2.5 times the financial gain*, whichever is lower

The new scales of the administrative charge now apply to company size verifications which have not yet been concluded.

 

Source: Verification of fee reductions - ECHA's Management Board adjusts administrative charge levels

Published in EU REACH NEWS

On 17 Mar 2015, the European Commission published decisions on authorisations for DEHP and DBP for specific purposes, and the date of expiry of review period is 21 Feb 2019.

The detailed information of decisions granting an authorisation are as follow:

Substance name

EC No

CAS No

Authorised use

Reasons for the decision

Bis(2-ethylhexyl)

phthalate (DEHP)

 

204-211-0

117-81-7

The industrial use of DEHP in the manufacture of solid propellants and motor charges for rockets and tactical missiles

— Risk is adequately controlled in accordance with Article 60(2) of Regulation (EC) No 1907/2006.

— There are no suitable alternatives at present and search for technically feasible alternatives is ongoing under a replacement programme with requalification requirements for defence industry products.

Dibutyl phthalate

(DBP)

201-557-4

 

84-74-2

The industrial use of DBP in the manufacture of solid propellants and motor charges for rockets and tactical missiles The industrial use of DBP within a specialty paint in the manufacture of motors for rockets and tactical missiles

Source: Decisions on authorisations for DEHP and DBP

Published in EU REACH NEWS
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