How to make a core data set and secure data access
The EU legislation on chemicals has set a new standard for registration of chemicals worldwide. Similar initiatives to strengthen the chemicals legislation are seen in many countries including China, Japan, Malaysia, Taiwan and Turkey. In the Republic of Korea, the new chemicals legislation (called K-REACH) became effective on 1 January 2015. Just like the EU legislation, K-REACH includes data requirements and risk assessment of all chemicals on the market.
This trend has a common background; a political intention to protect people and the environment from effects from hazardous chemicals. At the same time, there is a growing awareness of the lack of knowledge of the toxicological and ecotoxicological properties, and the actual use of a large volume of the substances on the market.
Address the challenge
International suppliers of chemical substances should be prepared to address this regulatory challenge by collecting available – or procure access to all necessary – substance data. In other words, you should create a core data set. Data should include substance identity, physical-chemical data as well as available toxicological and ecotoxicological data.
Restrictions on Letter of Access
Access to data obtained via a Letter of Access (LoA) from an EU based consortium is normally restricted for use only within the EU. A new agreement is required if registrations are made outside of the EU and often the LoA does not allow sublicensing to co-registrants. Together with the frequently high price for an LoA, these issues can be a barrier to the re-use of data across borders. Since GLP testing in qualified labs (OECD MAD compliant) is much cheaper in Asia, it is tempting to simply repeat the testing in order to get the full ownership.
Worries about double testing
The EU industry is concerned about duplication of tests. Not only does the duplication of test entail the use of additional test animals, but may also give different test results. These will have to be considered by the EU registrant in their dossier updating if the results become publicly available.
Our advice: create a core
On a global scale, the requirements for registration of chemical substances are increasing. It is important for manufacturers and suppliers to prepare a strategy for their regulatory compliance in order to secure the markets. DHI advise clients to create a core data set for all substances in their portfolio and to clarify data ownership, access to data and their user rights. The mapping should be matched against the data required by the authorities in the relevant countries to identify data gaps to be filled.
Example of similar data requirements
The data requirements are similar in the EU, China and the Republic of Korea. The table shows the requirements at the tonnage band from 10 – 100 ton per year. In general, test following OECD standard methodologies from GLP certified (MAD compliant) laboratories can be used. Non-test methods such as read-across and QSAR backed by adequate justification are also accepted. Sharing of data on vertebrate test data is mandatory in Korea but not in China, although the Chinese authorities encourage this. The Korean legislation enforces data sharing but it is possible to waive this if a ‘justifiable reason’ can be given, such as for reasons of confidentiality. It is also possible for a Korean registrant to waive joint submission due to cost reasons.
In the past 10 years, DHI has cooperated closely with the Korean research and consultancy institute KIST Europe, which has represented Korean chemical companies in the EU since 2006. As a Korean legal entity, KIST Europe provides services in K-REACH together with DHI. Through this unique collaboration, we have a long record of services to industry within all fields of chemicals regulation in the EU and abroad.
For more information on DHI services within Product Safety, Environment and Toxicology:
Tel: +45 4516 9200