As a direct consequence of the COVID-19, the manufacture and supply of disinfectants to meet the needs of European citizens and especially hospitals, healthcare professionals are now supported by ECHA through derogations from the normal regulatory requirements for biocidal products.
It is now possible to access the market faster by applying for permission to the relevant national authority and by relying on Article 55(1) of the Biocidal Products Regulation (BPR), if companies want to place disinfectants that contain an already approved active substance. The provision allows national authorities to allow derogations for a limited time from the standard product authorisation requirements in situations where there is a threat to public health. Companies must contact each of the individual EU countries to determine what the procedures are in order to place their products on the specific EU countries temporarily. ECHA is constantly supporting EU/EEA authorities for the application of derogations from the normal procedures.
Meanwhile, pre-registration phase for Turkish REACH-like regulation, KKDIK, still continues at high speed despite Turkey being also a country struggling with the impact of COVID-19 pandemic. Several thousands of pre-registrations are already completed by Turkish manufacturers, importers, Turkish subsidiaries of multinational companies and local Only Representatives. More importantly, an IPA (Instrument for Pre-Accession Assistance) project co-financed by the European Union and the Republic of Turkey started on 1 November 2019. Although the anticipated date for the completion of this 1,5 million EURO worth project is 31 October 2021, it is now closely followed by the potential registrants whether the project finalisation will be impacted and at which extend the chemical industry will suffer from this unexpected pandemic conditions.
IPA is a European programme for EU candidate countries. The beneficiary of the project; ‘Technical Assistance to Conduct Chemical Safety Assessments under the scope of REACH Regulation’ is the Turkish Ministry of Environment and Urbanization (MoEU) and the Chemicals Management Department who are responsible for the implementation of the KKDIK Regulation. The main objective of the project is to strengthen the existing capacity of the governmental and industrial institutions in the area of chemical safety assessments.
Below are the most important actions to be taken in the light of the project to bring chemicals management in Turkey in line with EU’s REACH Regulation.
- Integration of the chemical safety assessment tool Chesar into the existing online chemicals registration system; KKS
- Upgrading of the existing registration system, KKS, in accordance with the latest IUCLID version
- Update of outdated KKDIK Guidance documents to bring them in line with the latest versions of ECHA Guidance documents
- Translation and harmonisation of additional, new ECHA Guidance documents
- Organisation of seminars for regional authorities and industry to create and raise awareness amongst major groups and decision makers
- The Chemical Safety Assessment (CSA) ‘train-the-trainer’ course for 30 including study visits to ECHA and an EU Member State.
The ongoing IPA Project, as well as continuous updates to the KKDIK, SEA Regulations and online KKS system are efforts to harmonise Turkish chemicals regulations with the EU. Initial Substance Information Forum (SIEF/MBDF) communications have already started for some of the substances. Multinational companies are ahead of the game as they have REACH experience and data ownership which gives them a mission to act fast with hundreds of substances to register for KKDIK compliance.
RGS has been acting as the Only Representative for the last 12 years of more that 450 customers within EU REACH, and as the Only Representative and consultant of over 400 manufacturers within Turkish KEK/SEA/KKDIK regulations for manufacturers over 40 countries. The team of experts of RGS Group transferred years of experience into practical solutions for non-Turkish conpanies to comply with Turkish chemicals regulations. Do not hesitate to contact RGS, if you need more details on our services. We can assess your compliance status and build tailor-made solutions for your company within our due diligence approach.
Dr.Yaprak Yüzak Küçükvar
REACH Global Services Group
Director, Global Regulatory Affairs & Product Stewardship