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FI-02600 Espoo, FINLAND
Tel: +358 (0) 9 412 3055
Fax: +358 (0) 9 412 3049
Email: sales@reachlaw.fi
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Case Studies

Customer problems and the solution provided

REACH & CLP Services

CASE 1: REACH and CLP Advisory services to the European Defence Agency - EDA
Organisation nameEuropean Defence Agency ( EDA)
SectorEuropean Defence Sector
Services offeredREACH & CLP advisory services to conduct a study on the impact of REACH & CLP chemical regulations on the defence sector, both industry and governments to provide a way forward on the REACH regulation to the European Commission (EC), EU Member States Ministries of Defence (MoDs) and defence industry aiming for a win-win solution achieving both goals: high level of protection of health and environment and enhancement of competitiveness and innovation of the European defence industry.
Problem

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”.

Our solution

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.

 

Further information

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

 

CASE 2: Change of Only Representative
Organisation nameNon-EU manufacturer of chemicals
SectorSpecialty chemicals
Services offeredOR change service and subsequent OR representative and registration services
Problem

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 31st May 2018 and enforcement activities of continuous OR responsibilities increase, A wishes to change to an experienced leading REACH service provider as OR.

Our solution

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.   

Further information

Contact REACHLaw at sales@reachlaw.fi

CASE 3: REACH Awareness Activities
Organisation nameCIQyP- Argentinean Chamber of the Chemical and Petrochemical Industry
SectorChemicals & Petrochemicals/ Industry Association
Services offeredSeminars/workshops/webinars
Problem

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.

Our solution

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.

Further information

www.ciqyp.org.ar

CASE 4: Consortia Management Services
Organisation nameASD-Eurospace
SectorEuropean space sector
Services offeredCreation and management of sector-level industry task forces; development of joint dossiers for REACH purposes; trustee for confidential business information; co-ordination and communication with third parties.
Problem

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.

Our solution

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.

Further information

Chromate Space Task Force

Hydrazine Space Task Force

CASE 5: Co-Registrations
Organisation nameClient confidential, USA
SectorChemicals
Services offeredCo-Registration planning and execution for 2018 deadline
Problem

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

Our solution

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.

Further information

Client confidential, N/A

Reach Authorisation

CASE 1: Biopharma Industry
Organisation nameMedical drug developers covering own uses
SectorBiopharmaceutical industry
Services offeredAnalysis of alternatives; Socio-Economic Analysis; Chemical Safety Report
Problem

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated, commonly known as Triton X-100, is a nonionic surfactant very widely used during the manufacturing of pharmaceutical drugs, for instance,  in purification processes such as viral inactivation. It has endocrine disrupting properties for the environment and is covered by entries 42 and 43 on Annex XIV. Independent drug developers and service providers, namely contract development and manufacturing organization (CDMOs) produce medicinal products and active pharmaceutical ingredients (APIs) used in medicines. These products have to meet strict requirements set by regulatory authorities (e.g. EMA, FDA) to be approved for use as a medicine. Replacing Triton X-100 with an alternative in the manufacturing process generally require new tests to be conducted and new regulatory approvals to be acquired. In the worst case, the modification to the process may require clinical studies to be repeated.  For drug developers, substitution of Triton X-100 is a complex, expensive, lengthy process due to the regulatory requirements governing the safety and efficacy of medicines. For CDMOs working under contract, they cannot make these changes unless requested to by their client

Our solution

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 (4th July 2019) and are now being processed by the ECHA Committees.

Further information
CASE 2: In Vitro Diagnostics ( IVD)
Organisation nameUpstream applicants covering own uses and downstream uses of IVD products
SectorIn-vitro diagnostic device (IVD) for diagnostic assays
Services offeredAnalysis of alternatives; Socio-Economic Analysis; Chemical Safety Report
Problem

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.  

Our solution

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 (4th July 2019) and are now being processed by the ECHA Committees.

Further information
CASE 3: Authorisation Application - Chromium trioxide
Organisation nameCRAN – Finnish hard chrome authorization consortium
SectorSurface finishing
Services offeredAnalysis of alternatives; Socio-Economic Analysis; Chemical Safety Report
Problem

Chromium trioxide is entry 16 on the Authorization list with the sunset date of 21st September 2017. As it is so widely used, a consortium of upstream applicants decided to prepare an application covering all uses. There was a lot of uncertainty if the authorities would accept the approach taken and a group of seven SME Finnish hard chrome platers decided that they needed to protect their businesses by submitting their own specific down-stream user application specific for their use.

Our solution

We helped them form a consortium and prepare their own joint DU application. Their application was submitted on the 1st October 2015 and already received a Commission decision on the 10th October 2017 granting them a review period of 7 years.

As the joint upstream application has yet to receive a Commission decision, their decision to submit a DU application covering their uses proved to be the right decision to ensure their business continuity.

 

Further information

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

CASE 4: Authorisation Application - Sodium chromate
Organisation nameElectronic Appliance Manufacturer
SectorElectronic Industry
Services offeredAnalysis of alternatives; Socio-Economic Analysis; Chemical Safety Report
Problem

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.

Our solution

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

Further information

HERE

CASE 5: Authorisation Application - Diarsenic trioxide
Organisation nameDownstream User companies
SectorMining and smelting
Services offeredAnalysis of alternatives; Socio-Economic Analysis; Chemical Safety Report
Problem

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.

Our solution

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.

Further information

Pre-Authorisation/Advocacy

CASE 1: Legal assessments
Organisation nameHydrazine Space Task Force
SectorEuropean space sector
Services offeredIndustry survey; technico-legal exemption study; preparation of Industry Position Paper
Problem

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.

Our solution

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.

Further information

Hydrazine Position Paper

CASE 2: Advocacy support services - Electronics
Organisation nameElectronic component manufacturer
SectorElectronics
Services offeredPreparation of contribution to public consultation
Problem

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.

Our solution

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.

Further information

The reviewed restriction proposal is currently undergoing public consultation.

CASE 3: Advocacy support services
Organisation nameASD-Eurospace
SectorEuropean space sector
Services offeredPreparation of contribution to public consultation
Problem

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.

Our solution

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.

Further information

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

Global Regulations Services

CASE 1: Global Regulations
Organisation nameOne of the leading mining and metallurgical companies in the world
SectorMining and metallurgical sector
Services offeredCompliance with Turkish chemicals regulations
Problem

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.

Our solution

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.

Further information

Please contact our Sales Team via sales@reachlaw.fi

Out-Tasking Services

CASE 1: Out-Tasking
Organisation nameJohnson Controls, Germany
SectorMetals, Automotive
Services offeredREACH & CLP Out-Tasking and Support Services
Problem

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.

Our solution

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!

Further information

Digital Solutions

CASE 1: Digital Solutions > CompliantSuppliers
Organisation nameClient confidential, Belgium
SectorChemicals
Services offeredCompliantSuppliers
Problem

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.

Our solution

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

Further information

More information at: www.compliantsuppliers.com