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

We helped our clients demonstrate that substitution is not straightforward for them as they cannot readily modify their processes due to the strict regulatory requirements for medicines. For our CDMO client, we helped them demonstrate that substitution is not applicable as they manufacture under contract and do not have ownership of the process or the drug.  The applications were submitted before the latest application date (4^th July 2019) and are now being processed by the ECHA Committees.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated, commonly known as Triton X-100, is a detergent very widely used in IVD products is covered by entries 42 and 43 on Annex XIV. Due to the regulatory requirements for IVD products, substitution of Triton X-100 triggers the need for re-validation and re-registration of the products in each regulatory jurisdiction. The time needed can be 10’s of years due to the number of concerned products and the number of markets each with their own requirements for re-registration. IVD manufacturers need authorization to continue their use and to cover their down-stream users (DUs) who use their products in e.g. neo-natal screening, animal health, and infectious disease diagnosis while they obtain regulatory approvals for alternatives in the IVD products. Concerned DUs range from hospitals, medical centers, veterinary clinics, dairy product suppliers.  

We realised that information from the DUs was essential to determine where and how the IVD products are used and disposed of. Using customised questionnaires, we collected information from DUs and used it to quantify the risk from the use of Triton X-100 in the IVD products. For some, the number of DUs was significant and 100’s of questionnaires were collected. We used this approach for the preparation of all of applications and for all, we could demonstrate that the risk remaining is insignificant compared to benefits of continued use. The applications were submitted before the latest application date (4^th July 2019) and are now being processed by the ECHA Committees.

Details of the application are available on the ECHA webpage: here

Sodium chromate has been included in the REACH authorisation list with a sunset date in September 2017. The company applying for authorisation produces goods for mobile comfort lifestyle, and the substance listed for authorisation is essential for the function of a specific product of the applicant. A use-specific Analysis of Alternatives and Socio-Economic Analysis for authorisation were prepared to ensure continued use after the sunset date as long as required.

REACHLaw collected information from the client and based on that information formulated a realistic non-use scenario for the joint AoA and SEA report.

HERE

Diarsenic trioxide (As2O3), a substance used in zinc electrowinning process, had been included in the REACH authorisation list with a sunset date in May 2015. A sector specific Analysis of Alternatives, Socio-Economic Analysis and Chemical Safety Report for authorisation were prepared to ensure continued use after the sunset date as long as required.

REACHLaw collected relevant information on the use of diarsenic trioxide and based on the data received REACHLaw prepared the AoA, SEA and CSR reports. The Applications for Authorisation were submitted in 2013. The cases were successful as in autumn 2015 the European Commission decided to give the applied 12 years review period for the cases.

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.

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