1. How K-REACH Will Affect the Flavors and Fragrances Industry
The final draft of the Act on Registration and Evaluation of Chemicals in Korea (aka “K-REACH”) was published on the 30th of April 2013 and will come into force on the 1st of January 2015. K-REACH will replace the previous new chemical notification system under Toxic Chemical Control Act (TCCA) of the MoE and Occupational Safety and Health Act (OSHA) of the Ministry of Employment and Labor (MoEL). K-REACH will be the first REACH-style chemical regulatory system adopted in Asia. K-REACH will regulate new chemical substances, existing chemical substances and downstream products by prescribing requirements for registration, hazard evaluation, and risk assessment. These substances will of course include substances classified as flavors and fragrances.
2. Regulation of Flavors and Fragrances under K-REACH
Under K-REACH flavors and fragrances are defined as substances with aromas or flavor characteristics produced and/or imported for the purpose of manufacturing a new chemical substance (chemically reacted) or mixture (physically mixed) using manufactured and/or imported chemical substances as ingredients. According to K-REACH, regulatory obligations for these chemical substances are annual reporting, registration, risk notification and supply chain communication. However chemical substances with these characteristics that are used for the production of cosmetics or food additives are exempted from K-REACH.
MoE has published the first batch of priority existing chemicals list (draft) which contains 518 chemical substances. The final version of the PEC list will be officially announced by the MoE in June 2015. Chemical substances that are listed in the first PEC list require registration before June 2018. If flavor or fragrance chemical substances meet one of the conditions listed below then registration should be finalized before manufacturing or import of these substances. For new substances registration is required immediately and for PECs registration is required before 2018. Similar to EU-REACH, K-REACH will also adopt the Only Representative (OR) concept to allow non-Korean companies to register using an OR (e.g REACH24H).
Flavors and Fragrances chemical substances subject to Registration:
- new chemical substances (regardless of tonnage)
- Priority Existing Chemicals substances (PECs) over 1 ton per year
- Existing chemical substances which pose a high risk to human health and the environment (under 1 ton per year and appointed by MoE).
As for the annual reporting requirements for flavors and fragrances under K-REACH, manufacturers, importers or sellers of existing chemical substances at or above 1 ton/year and all new chemical substances regardless of the tonnage are obliged to report volume and usage to the MoE. The substance tonnage and usage information of the previous year (1 Jan-31 Dec) should be submitted before 30 Apr each year. The first report will be required by June 2016.
Flavors and fragrances are mainly manufactured or imported in Korea for use in everyday chemical products. According to K-REACH article 16, products used by ordinary consumers for daily use, such as detergents, fragrances, adhesives, deodorants, synthetic detergents, bleaching agents are defined as products of risk, which require product notification to the head of local environment administration. Product notification is also required when hazardous chemical substance contained in a product exceeds 1 ton per year and the content exceeds 0.1%. The hazardous chemical name, content and hazard information must be declared in advance.
In order to help downstream users use products safely and minimize the risk to humans and the environment, suppliers of registered flavors and fragrances (or mixtures of these substances) which contain registered chemical(s) shall provide the registration number, chemical name, hazard information, safe use information to the recipient. It is necessary to stress that the Korean authority requires companies that export chemicals and products to Korea to provide Korean SDS and labeling.
3. How to Comply with K-REACH regulation on Flavors and Fragrances
General step of Flavors and Fragrances industry comply with K-REACH is as following:
- List the products
- Calculate the tonnage of chemical products export to Korea
- Check the export products belong to new chemical substances or existing chemical substances(KECI);
- Confirm exemption or obligations under K-REACH;
- Collect the identification information of all chemical products;
- Contact and entrust a professional only representative(OR)
Due to the complexity of the flavors and fragrances, relevant stakeholders need to pay attention to the following matters to comply with K-REACH.
Firstly, identify chemical substances.
Under K-REACH, substances can be divided as mono-component, multi-component, UVCBs according to the information of composition and content. Compared to other substances, not many flavors and fragrances are mono-component. Instead they are usually multi-component or UVCBs.
Secondly, join a Consortium and share test data.
According to the author’s experience under EU-REACH most big enterprises for flavors and fragrances complete their substance registration individually instead of establishing consortiums. However joining a consortium is still the most economical way to register substances that have the same SIP (substance identification profile). According to K-REACH, registrants should jointly submit data when applying for registration of existing chemical substances subject to this registration type or otherwise obtain a confirmation of individual submission from MoE). Flavors and fragrance companies should keep lines of communication with their OR open to stay abreast of the latest joint submission information.
In conclusion, the change from regulating chemicals under the TCCA to the K-REACH will beyond any doubt have a great impact on Korea’s chemical industry. A thorough understanding of regulatory requirements and compliance obligations and subsequent preparation of a compliance strategy is imperative to maintain normal business operations during the implementation of K-REACH.