Case Studies

The REACH and CLP Regulations (and the processes involved e.g. authorisation, restrictions) may have a significant impact on European defence capabilities during the whole life cycle of defence equipment (design, manufacturing, in-service use and maintenance, disposal) and therefore on the European Defence Technological and Industrial Base. EU MoDs and their suppliers, namely defence industry, may not be able to implement all technological changes needed in order to be REACH compliant at a reasonable cost while maintaining the required performance level. In addition to REACH and CLP, other European Regulations on chemicals (e.g. BPR, ODS, POP) also have an impact on European defence capabilities.

Against this background, the EDA commissioned REACHLaw Ltd. to carry out a “Study on the Impact of REACH and CLP European Chemical Regulations on the Defence Sector”.

To gather the study input, more than 100 stakeholder organisations including EU MoDs, EU and non-EU defence industries, the European Commission, ECHA and REACH Member State Competent Authorities were consulted. Based on the in-depth REACH impact assessment REACHLaw elaborated recommendations for the EC REACH review 2017 and for European defence stakeholders. The study was supported by the EDA REACH Task Force (comprised of MoD REACH experts).   

The study was conducted between May and December 2016. The Final Report is available on the EDA website.

http://eda.europa.eu/info-hub/press-centre/latest-news/2017/01/26/eda-study-on-the-impact-of-reach-clp-european-chemical-regulations-on-the-defence-sector-released

Non-EU manufacturer A has pre-registered a number of substances through a  small EU-based consultancy as OR in 2008. As registration is due by 31^st May 2018 and enforcement activities of continuous OR responsibilities increase, A wishes to change to an experienced leading REACH service provider as OR.

REACHLaw supports manufacturer A with the termination of the appointment of the previous OR and seeks its consent to the OR change. An OR agreement between REACHLaw and A is concluded. Pre-registrations are transferred to REACHLaw using the Legal Entity Change ‘handshake’ functionality in REACH-IT. EU importers are then informed about REACHLaw as the new OR.   

Contact REACHLaw at sales@reachlaw.fi

Since the year 2007, the CIQyP has been a pioneer in promoting REACH compliance among their member companies. CIQyP was looking for a suitable EU expert to help their member companies to understand their challenges and REACH obligations.

Since the year 2008, REACHLaw has delivered several seminars, workshops and webinars, in the local language for the CIQyP member companies. We have addressed REACH, CLP, REACH Authorisation and Supply Chain management topics, to help the Argentinean chemical industry to cope with the REACH & CLP requirements.

www.ciqyp.org.ar

Critical substances for space applications are being included in the REACH candidate list (e.g. hydrazine) and authorisation list (e.g. chromium trioxide). Major European space companies, the European Space Agency and national space agencies want to work together to ensure continued use as long as necessary while fully complying with the REACH authorisation requirements.

REACHLaw develops the project plan and task force as well as confidentiality agreements for the approval of the industrial and space agency participants. Within the frame of the task force the joint documents supporting the applicable authorisation approach are elaborated (e.g. exemption justification, authorisation dossier), co-ordinated with third parties and presented to the REACH competent authorities (e.g. ECHA, European Commission). REACHLaw project manager ensures protection of confidential business information.

Chromate Space Task Force

Hydrazine Space Task Force

Determining a proper Co-registration strategy for the last REACH deadline to determine the total costs, workload and analytical tests required.

Identify all potentials substances (several hundred substances) that have a “business case” post 2018 and potential new substances. Based on this “shortlist”, identify the existence of SIEF’s or PRE-SIEF’s (whether there is a Lead Registrant or not) and potential LoA / Consortium membership fees. Furthermore the analytical test requirements were mapped and gaps identified. Based on this 2018 Strategy, the Client can now budget for 2018 registration and even out the cost peaks.

Client confidential, N/A

Chromium trioxide: entry 16 on the Authorisation List

We have prepared applications for various decorative and functional chrome plating uses of chromium trioxide for our clients, including 13+ applications since 2020 alone. The applicants varied from single downstream users to joint downstream users to consortium applications. The applications covered initial applications and review reports. Our clients chrome plate diverse components for equally diverse sectors that included sanitary, automotive, engineering components, aerospace and defence. They range from SME job platers to OEMs. We have prepared applications for both EU and UK REACH.

We have assisted our clients through every step of the application process, from collecting the information needed to prepare the reports, drafting the reports, submission to ECHA, responding to questions from the ECHA committees, replying to comments in the public consultation, assistance with the trialogue meeting and comment on the draft ECHA committee opinions. We have keep our clients informed of the status of decision making on the application and assisted them provide input at every step in the process.

 Contact us for more information on our authorisation services at authorisation@reachlaw.fi

Octylphenol and nonylphenol ethoxylates: entries 42 & 43 on the Authorisation List

We prepared applications for invitro diagnostic device (IVD) companies covering both their own use of the surfactants in the production of IVD kits/assays at industrial sites and for their customers who use the kits in disease/condition diagnosis in professional settings like hospitals, veterinary clinics and government labs. We have also prepared applications for UK REACH for downstream users.

All the applicants received their requested review periods.

We also assisted companies determine whether use by their customers would fulfil the scientific research & development (SR&D) criteria to be exempt from the authorisation requirement. 

Contact us for more information on our authorisation services at authorisation@reachlaw.fi 

4,4′-methylenebis[2-chloroaniline](MOCA): entry 27 on the Authorisation List

We act as only representative applicant for the non-EU supplier of MOCA covering use in the manufacture of polyurethanes. We prepared the upstream application and submitted it before the latest application date. Since the sunset date (22^nd November 2017), downstream users in the supply chain are covered by transitional arrangements until the European Commission takes a decision on the application. Decision making on this application has been delayed as the Commission requested the submission of substitution plan in 2020. We have prepared the substitution plan and kept the downstream users informed of the status of the application – see our webpage for more information on this application https://www.reachlaw.fi/reachlaw-as-or-applicant-for-suzhou-xiangyuan-new-materials-co-ltd-for-use-of-moca/

We have also assisted downstream users to prepare their own applications. We prepared the MOCA consortium application and the ECHA committee opinion on their application recommends granting authorisation. The decision-granting authorisation is expected to be issued in Q3 2023.

We have also assisted users determine whether their use fulfils the criteria for “intermediate use” as clarified in the 2018 acrylamide court ruling (Case C‑650/15 P) and later in the 2022 updated ECHA Guidance on Intermediates.

 Contact us for more information on our authorisation services at authorisation@reachlaw.fi

Lead metal: candidate for inclusion on the Authorisation List

An entry for lead metal is on the candidate list for inclusion on the Authorisation List since 2018. We assisted a group of companies who make lead sheeting engineering products for diverse sectors scope authorisation requirements for use of their products by their customers. A key finding of our scoping study was that lead engineering products are widely used in diverse sector and that alternatives proposed for many of these uses are not available in the quantities needed and many are on the EU critical raw materials list. In addition, due to absence of alternatives, potentially 1000’s of applications for authorisation would need to be submitted depending on where the transition from “substance” to “article” is made.

We assisted the group of companies provide input in both the ECHA public consultation on its 11^th draft recommendation to include an entry for lead metal on the Authorisation List. We also assisted them submit detailed information in Commission parallel public consultation on the socio-economic impacts for each of its seven use categories.

Contact us for more information on our authorisation services at authorisation@reachlaw.fi 

Hydrazine (anhydrous), a strategic component for satellite and launcher programmes, has been included in the REACH candidate list for authorisation in June 2011. An exemption from authorisation under REACH Article 56(4)(d) “use as fuels in closed systems” could apply, but actual use conditions in the European space industry and prerequisites of the exemption clause need to be analysed to confirm it. The interpretation should be clarified with REACH authorities.

REACHLaw – in collaboration with ASD-Eurospace – has conducted a space industry survey to collect relevant use information. Based on the data received, REACHLaw has analysed and confirmed the applicability of REACH Article 56(4)(d) and other REACH exemption clauses. The conclusions have been included in a ASD-Eurospace Position Paper drafted by REACHLaw and endorsed by all participants of the Hydrazine Space Task Force. The Position Paper has been presented to the European Commission to obtain its legal clarification.

Hydrazine Position Paper

The European Commission launched a public consultation on restriction proposal for Perfluorooctanoic acid (PFOA), PFOA salts and PFOA-related substances. A substance included in this category is used in the manufacturing process of electronic components by a DU company.

REACHLaw prepared a DU company specific comment comprising of a realistic non-use scenario, Socio-Economic Analysis and Analysis of Alternatives. The arguments used were in line with the comment from the industry sector representative. Based on the comment, ECHA committees proposed to exempt the use of the PFOA-related substance in electronic component manufacture without a review period.

The reviewed restriction proposal is currently undergoing public consultation.

The European Commission launched a public consultation on streamlining and simplification of REACH authorisation for uses of Annex XIV substances in low volumes and in legacy spare parts. A joint sector-level contribution should be prepared to highlight space-specific demands.

REACHLaw prepared the sector-level contribution comprising technical, legal and industry arguments, taking into account the comments of space agencies, companies and ASD-Eurospace as the industry association. The Commission is planning to introduce more sector-friendly authorisation rules for these uses.

The ASD-Eurospace contribution can be found on the Commission website.

Compliance with EU REACH, Turkey KKDIK and UK REACH

A North American chemicals manufacturer is placing chemicals on all the following markets: EU, UK, and Turkey. Through REACHLaw, we have supported them as their EU Only Representative since 2010. With the entry into force of the Turkey KKDIK regulation in 2017, REACHLaw has also been their Only Representative in Turkey via our office in Istanbul. Furthermore, access to the UK market is relevant for our client and therefore, REACHLaw is supporting the Client in keeping access to the UK market through our Manchester office functioning as the UK REACH Only representative for Lead registration and co-registration of their substances that are placed on the GB market and are in the scope of UK REACH regulation.

For more information, contact us at sales@reachlaw.fi 

Turkey KKDIK: Data-sharing related implications 

Data sharing is key to success in developing the Lead dossier for the Joint Submission. It is imperative that the same information is, as far as possible, used across different chemical regulations to ensure that deviation in the data as submitted will be as little as possible. This will ensure that authorities will not find “arbitrage” opportunities between regulations.

REACHLaw has, as part of providing lead registration services, currently most prominently for Turkey KKDIK purposes, assisted several of our clients in the re-utilization of existing data as much as possible. Typically, such data emanates from the EU REACH registration process and related tests as performed, but, in some cases, data has also been acquired from sources not previously used as endpoint data, typically for read-across purposes. In such cases, it has been important to keep potential deviations to a minimum from the EU REACH dosser.

REACHLaw utilizes its long experience gained from the EU REACH registration process in assuring the end result for data sharing and related cost sharing is as optimal and cost efficient as possible. REACHLaw leverages its knowhow both for the scientific as well as administrative part of the data sharing process for the best results for both the Client and regulatory compliance

Contact us at sales@reachlaw.fi for support.

Turkey KKDIK Registration deadline:  31 December 2023.

REACHLaw is currently assisting many of its Clients with Turkey KKDIK Lead Registration for the 31 December 2023 registration deadline, both as a service provider and as an Only Representative as the KKDIK Lead Registrant. Compared with EU REACH, the KKDIK Lead Registration work is for the most part an exercise in administrative and technical work. Therefore, the lead registration process has been relatively quick to complete to the point of submission of the lead dossier, provided no significant issues in obtaining legitimate data access and sub-licensing rights for Co-registrants wishing to join the Joint Submission.

In some cases, sub-licensing is not granted and therefore, each registrant, lead registrant included, have had / will have to obtain the data use rights directly from the data holder residing outside of Turkey, typically the EU REACH lead registrant or consortium. After submission, when the total cost of work and data has been fixed, at least to that point, the Letter of Access sales start for the purpose of admitting other companies aiming to register the same substance into the Joint Submission.

Although, no data sharing regulation as such is yet in force in Turkey, REACHLaw has advised its clients to work with the Lead Registration as if such a regulation would be in place. REACHLaw continues its work with the KKDIK Lead Registrations with the aim of submitting these to the Turkish Ministry of Environment, Urbanization and Climate Change in good time ahead of the registration deadline, thus allowing KKDIK Co-registrants ample time to purchase the Letter of Access and joint the Joint Submission.

For more information about our Turkey KKDIK lead registration services, please contact us at sales@reachlaw.fi 

In the past few years Turkey has adopted new CLP and SDS Regulations (“SEA” and “GBF” respectively) imposing new obligations on the companies that are placing their chemicals on the local market. Under SEA the C&L notifications are to be completed by June 1, 2015. The GBF regulation requires companies to prepare compliant SDSs in Turkish language by a locally certified expert (a license is required) and submitted to the Turkish Ministry for substances by June 2015 and for mixtures by June 2016. Our Customer requested to provide all the required services to comply with new obligations relevant for a non-Turkish manufacturer.

REACHLaw has classified all Customer’s substances under SEA, prepared and submitted the notifications to the Turkish Ministry by the deadline. Since Customer is a non-Turkish manufacturer, REACHLaw subsidiary in Turkey was appointed as Legal Representative to complete the notifications. As required under GBF, a duly authorised REACHLaw specialist has prepared all Customer’s SDSs and certified them in the Section 16.

Please contact our Sales Team via sales@reachlaw.fi

Maintaining REACH & CLP Regulatory compliances is becoming increasingly time-consuming and demanding due to regulatory changes, new interpretations and constantly updating reporting software and IT solutions. Keeping up and maintaining an organisation to manage these is resource demanding and costly, without the possibility of optimization as most regulatory tasks are unique. This is the case with the chemical supplier, too many REACH & CLP compliance issues to follow and compliance tasks to maintain.

Although a unique issue for the chemical supplier, managing compliances is not unique for REACHLaw and this is why we offered the chemical supplier with a REACH & CLP Out-Tasking and Support Service that, amongst others, maintains dossier compliance and follows and alerts of regulatory changes affecting the products of the chemical supplier. The supplier is still in control of overall compliance but REACHLaw provides a service that takes care of the technical and special compliance tasks that need special competence which otherwise would be costly and resource demanding to maintain within the company. Problem solved!

As a downstream user of hundreds of chemicals, the confidential company in question was concerned with the REACH and CLP compliance status of the chemicals they procure or intends to procure. The company was attempting to do a compliance check on all chemicals from the various suppliers manually by email and excel questionnaires but soon found out that the suppliers were not responding to the questionnaires.

The compliance check tool CompliantSuppliers available on-line at www.compliantsuppliers.com was utilized as an alternative using its “customer campaign” –feature. All relevant suppliers were invited to report REACH & CLP compliance information on their products supplier to the Client and the response rate was 94 % to the first contact or at the latest the second reminder. The campaign was initiated and once the recipients were identified the campaign could be launched immediately. As a result of the campaign, 30 % of the respondents had some irregularities with their products compliance status whilst another 30 % had poor or very poor and non-compliance (e)SDS for the supplier chemical products. Around 5 % of the chemicals were deemed non-compliant and the Client had to find another supplier for these chemicals. Some additional potential suppliers were also found on CompliantSuppliers

More information at: www.compliantsuppliers.com