REACH24H Consulting Group

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It is reported in the news released by ECHA on 22 February that some companies falsely claimed to be lead registrants (LR) for certain substances. Here REACH24H Consulting Group would like to kindly suggest that companies give a second thought to the credibility of the claimed LR. According to the core principle of “one substance, one registration” of EU REACH, the election and determination of LR must follow specific procedures. The claimed LR identity can be problematic in that the nomination might has not been agreed between the co-registrants, another lead registrant could have been selected or even a joint registration has been already submitted. If you are approached by such a company, you should not accept their offer to prepare a joint registration, but to look for the real lead and other registrants of your substance. For the invitation from a claimed LR, be it true or false, it is always better for companies to turn to their Only Representative (OR) for confirmation.

Admittedly, the claimed LR might offer a quite appealing offer of LoA cost without a full conformity to the REACH rules. However, more often than not the dossier quality can be far from satisfaction, possibly triggering additional costs for the update of data later. Then what to do if a self-claimed lead registrant contacts you before you identified your co-registrants? Here below are some advices from the ECHA news for you to check their validity:

  • Ask for details on the identity of the substance to establish substance sameness.
  • Ask for evidence that they have the consent of the co-registrants to act as a lead registrant.
  • Ask for evidence that they have sufficient information for a compliant dossier.

Also, if your company is experiencing difficulties in verifying the validity of the lead registrant, you can contact the ECHA Helpdesk for further advice and possible intervention. After all, the main task of the lead registrant is to submit the joint registration dossier containing all information needed for a compliant substance registration while it is the responsibility of all co-registrants to get access to data based on cost sharing.

As a pioneering consulting company in China to study on EU REACH, REACH24H has a professional team specialized in SIEF communication, boasting a long-time favorable communication with large chemical companies and associations as well as official experts. We have followed closely the registration updates of thousands of substances with pretty much experience in SIEF communication. Besides, the online SIEF Record System developed independently by REAHCH24H has greatly facilitated an efficient and accurate identification of the right LR for each substance, thanks to its accumulated comprehensive information from daily communication and consistent updates of each substance.

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

Published in EU REACH NEWS

On 10 February 2016, the European Chemical Agency launched consultation on 27 applications for authorization covering 39 uses of the following 3 substances. The consultation period will expire on 6 April 2016. Any comments if available shall be submitted before that date.

Substance Name

Use Description

Chromium VI compounds

Used in surface treatment, hard and functional chrome plating, cooling systems, passivation of tin plates, production of copper foils, production of coloured stainless steel, and manufacture of sodium chlorate/chlorite. These uses take place in various industry sectors such as chemical industry, aerospace, automotive, electronics, lithography

1,2-dichloroethane (EDC)

Used as solvent in the production of a polymer

Diglyme

Used as solvent in the manufacture of an active pharmaceutical ingredient

More information is available on the ECHA Website.

Chinese Version: ECHA就3类物质的27份授权申请开展公众咨询

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

Recently, ECHA published the final report of the third REACH-EN-FORCE (REF) Project. REF3 covered 28 countries, with 1,169 companies and 5,746 substances inspected during 2013-2014. Detailed investigations during phase 2 of the project revealed that only representatives (OR) and importers are more at risk of non-compliance than manufacturers of substances.

As is described by ECHA, “The project was coordinated by ECHA's Enforcement Forum and implemented in close cooperation with national customs authorities.” A total of 104 ORs were inspected and a third of them (32 %) did not comply with their specific OR information duties as described by Article 8 of REACH. The investigation revealed that the supply chain data (e.g. tonnage coverage) collected from importing downstream users was regularly inconsistent with the information provided by the OR.

“The flow of information in the supply chain between only representatives and importing downstream users was poor. It was often difficult to establish the structure of the supply chain as the respective importers could not specify the correct only representative and the only representatives did not keep reliable records of represented importers.”

The table below summarizes some of the key non-compliance issues noted in the report.

Key Non-Compliance Issues:

Having successfully completed 2 inspections by the Irish national authorities, we would like to describe our efforts to assist downstream users (DU) in the EU to achieve compliance. To fulfil our obligations under Article 8 of the REACH Regulations, REACH24H designed and developed a secure online IT tool, the REACH Supply Chain Compliance System (RSCC System) in 2010. The purpose of the RSCC System was to efficiently manage the REACH information communication between global supply chain actors (non-EU manufacturer (NEM), importing DU, non-EU distributor (NED)) and OR.

Based on the practical experiences of the first inspection phase of the third REACH-EN-FORCEREF3 in 2013, REACH24H upgraded the system (NEW REACH Supply Chain Compliance System (NEWRSCC)) in advance of the second inspection phase. We received very positive feedback from the inspector about the functionality of the system and how NEMs, NEDs and importing DUs were able to effectively access REACH compliance documentation (Confirmation letters, REACH compliance tonnage coverage certificates, SDSs, etc.) using this tool. Therefore, we formally released the NEWRSCC in January 2015.

After using the NEWRSCC for one year, our clients have experienced increased efficiency in the access to and management of all REACH compliance documentation. All actors in the supply chain, including NEM, NED and importing DU can review and download REACH documentation in their own accounts. The automatic monitoring of the tonnage volume for each specific substance in the relevant tonnage band also enables the importing DU to download REACH compliance tonnage coverage certificates without delay.

How to utilize the NEWRSCC to optimize your REACH compliance?

We believe the NEWRSCC is already implementing some of the key recommendations noted in the REF3 report to “define an explicit duty for a documented contact/exchange of information between the importing DU and the OR” as follows:

• explicitly defining the duty for an importing DU to keep a documentation for the relevant substance(s) with annual tonnages confirmed by the OR(s) (e.g. keeping confirmation documents from the related ORs).

When included in the DU list of your non-EU supplier(s) (manufacturer or distributor) in the NEWRSCC, you may connect with several suppliers from one account. All the tonnage coverage records and related REACH compliance tonnage coverage certificates will be available in your NEWRSCC account which you are able to securely access at any time.

• stipulate that only an importing DU keeping such documentation is released from the registration duties of an importer.

Being included in the DU list alone does not release an importer from their registration duties; to achieve this please follow these steps: (i) Ask your supplier to input tonnage records in the NEWRSCC. (ii) Verify and confirm the tonnage information entered by your supplier (iii) Verification by the OR releases the REACH compliance tonnage coverage certificates in your NEWRSCC account for you to download and retain for any inspections.

• Define a new duty for the OR to send the information on covering the registration duties for the importing DU for a specific substance and the information about the related annual quantities of the substance imported according to its lists (i.e. the tonnages covered by the OR) to the importing DU.

We provide a REACH registration ‘Confirmation Letter’ to the supplier that details the specific substance(s), CAS number, tonnage volume and (pre-) registration number (if permitted) together with our contact information. The supplier can then provide a copy to any potential EU importer customer with the advice to contact us so we can begin the process of adding them to the DU list and issuing documentation to release them from their registration obligations.

Further point to note from the report is:

For the import of mixtures, the importers will also need to know what quantity of the substance in a mixture is covered by an OR registration, as they would otherwise be subject to a registration requirement themselves.

Check List for Importing DUs – Have you received these documents from suppliers / OR?

  • Power of Attorney
  • Submission Report
  • REACH Registration Confirmation Letter
  • Tonnage Coverage Certificate
  • Safety Data Sheet
  • Exposure Scenarios (Annex to SDS)

* According to the Article 31(7) of REACH regulation, any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sheet covering identified uses and including specific conditions resulting from the application of section 3 of Annex XI. In Article 14 it is stated that if the substance meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the exposure scenarios, exposure assessment and risk characterization. So for the substance meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB, the exposure assessment is required, and then the exposure scenarios should be placed in annex to the safety data sheet.

In summary, active communication between the importing DU and OR is essential. As the OR may be appointed by many NEMs and the importing DU may have suppliers, using a secure online IT tool like the NEWRSCC System facilitates effective REACH compliance administration.

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

Published in EU REACH NEWS

To protect the welfare of animals, ECHA has started requesting additional information from registrants who submit new testing proposals for vertebrate animal tests as an approach to ensure that testing on animals is only done as a last resort.

According to the news released by ECHA on November 2, ECHA has sent the first requests to registrants asking them to inform ECHA of their considerations of alternative methods to support their testing proposals involving vertebrate animals. This affects testing proposals made since 11 September 2015.

ECHA will publish the information received concerning considerations of alternative methods together with the testing proposals on ECHA's testing proposals consultation web page. In this way, third parties can get access to such information and consider more comprehensively when deciding whether to submit relevant information about the substance from alternative methods that may avoid the test. More information will be taken into consideration by registrants in ways to fulfill the REACH information requirements.

The news cites what ECHA's Executive Director Geert Dancet says: "ECHA is committed to avoiding any unnecessary testing on animals while ensuring the safe use of chemicals. This new information request to registrants proposing a vertebrate animal test is one of the steps ECHA promised to take in response to the Ombudsman's proposed solution. Human health, safe environment and innovation are the main goals of the REACH Regulation but in ECHA's view, any unnecessary testing on vertebrate animals needs to be avoided whenever it is scientifically justified."

ECHA aims to enable companies to show their considerations in registration dossiers following the next update of the IUCLID tool in 2016. In the meantime, registrants will be contacted through REACH-IT.

Source: ECHA asks registrants to show how they considered alternative methods before consulting on testing proposals

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 15 June 2015, ECHA added two new substances of very high concern (SVHCs) to the Candidate List. The Candidate List now contains 163 substances, and 31 of them have subsequently been included in the Authorisation List.

The detailed information of these two substances are as follow:

Substance Name

EC Number

CAS Number

SVHC Property

1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters;
1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)

271-094-0
272-013-1

68515-51-5
68648-93-1

Toxic for reproduction

karanal
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]

/

/

vPvB

What is Candidate List?

“The Candidate List is a list of substances that may have serious effects on human health or the environment. Substances on the Candidate List are also known as “substances of very high concern”. The aim of publishing such a list is to inform the industry and general public that Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu these substances are candidates for inclusion in the Authorisation List. The inclusion in the candidate list also triggers further information obligations for industry and gives consumers the possibility to request information on these substances in articles. ECHA regularly prioritises the substances included in the Candidate List and recommends to the Commission their inclusion to the Authorisation List. Once they are on the Authorisation List, industry will need permission to continue using the substance after the sunset date”-ECHA Official Website

Related News: Two potential SVHC dossiers are open to the public consultation

Source: Two new substances of very high concern (SVHCs) added to the Candidate List

Published in EU REACH NEWS

On 8 June 2015, the EU’s Official Journal announced an amendment to the Fee Regulation that ECHA will adapt the fees and charges to the 2013 inflation (+1.5%). The new fees will come into force on 25 June 2015, and all invoices for REACH will automatically reflect the new fees as of that date.

The detailed fees are as follows:

Fees for registrations submitted under Article 6, 7 or 11 of Regulation (EC) No 1907/2006

 

Individual submission

Joint submission

Current Fee/€

New Fee/€

Current Fee /€

New Fee /€

Intermediate

1714

1739

1285

1304

Fee for substances in the range of 1 to 10 tonnes

1714

1739

1285

1304

Fee for substances in the range 10 to 100 tonnes

4605

4674

3454

3506

Fee for substances in the range 100 to 1 000 tonnes

12317

12501

9237

9376

Fee for substances above 1 000 tonnes

33201

33699

24901

25274

Reduced Fees for SMEs of Individual Submission

 

Medium Enterprise

Small Enterprise

Micro Enterprise

Current Fee /€

New Fee /€

Current Fee /€

New Fee /€

Current Fee /€

New Fee /€

Intermediate

1114

1131

600

609

86

87

Fee for substances in the range of 1 to 10 tonnes

1114

1131

600

609

86

87

Fee for substances in the range 10 to 100 tonnes

2993

3038

1612

1636

230

234

Fee for substances in the range 100 to 1 000 tonnes

8006

8126

4311

4375

616

625

Fee for substances above 1 000 tonnes

21581

21904

11620

11795

1660

1685

Reduced Fees for SMEs of Joint Submission

 

Medium Enterprise

Small Enterprise

Micro Enterprise

Current Fee /€

New Fee /€

Current Fee /€

New Fee /€

Current Fee /€

New Fee /€

Intermediate

835

848

450

457

64

65

Fee for substances in the range of 1 to 10 tonnes

835

848

450

457

64

65

Fee for substances in the range 10 to 100 tonnes

2245

2279

1209

1227

173

175

Fee for substances in the range 100 to 1 000 tonnes

6004

6094

3233

3282

462

469

Fee for substances above 1 000 tonnes

16185

16428

8715

8846

1245

1264

In addition, fees for the update of registrations, data confidentiality, PPORD notifications etc. will also rise by 1.5% from 25 June.

 

Source: ECHA fees adjusted for inflation

Published in EU REACH NEWS
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