In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. With an estimated 44,000 chemicals in use in South Korea and about 300 new chemicals marketed annually, registrants and regulators will be kept busy assessing the risk posed to humans, animals and the environment by these chemicals. Effective Jan 1, 2019, this legislation has been revised to impose stricter controls on a broader range of substances.
12在K-Reach下准备物质注册的必要步骤
化学regulations are often complex and difficult to understand. Demonstrating regulatory compiance is getting more challenging. Use these 12 insightful steps for preparing your substance registration under the changing regulations of K‑REACH.
For further information on K-REACH read our white paper,“如何为K-Reach立法做准备。”
K-REACH Legislative Development and Goals
K-REACH是韩国版的欧盟法规，用于化学品的注册，评估，授权和限制（REACH）。K-REACH并达到分享编目化学危险信息的主要目标，以支持在使用中提高风险管理。
Step 1: Start the registration process as early as possible.
Step 2：检查与您的物质相关的最新监管要求。确定哪些立法是相关的，并审查您在每项立法下的义务。
The two pieces of legislation introduced were the Act on theRegistration and Evaluation of Chemicals(K-REACH), which mandates the registration of all new and existing chemicals marketed or imported into South Korea at ≥1 tonne per year, requiring detailed information on their likely hazard to human health and the environment; and the化学s Control Act(CCA), which focuses on chemical reporting and chemical accident prevention.
K-REACH和CCA取代了现有的有毒Chemical Control Act (TCCA) to provide enhanced protection against chemical hazards. The drive for enhanced legislation was triggered in response to an outbreak of toxic lung injuries related to inhalation of a disinfectant used to clean humidifiers.
Scope of K-REACH
As with REACH, K-REACH is confined to certain substances. Unlike REACH, where annual tonnage is calculated as a three-year rolling average and regular monitoring and updates are required, K-REACH annual tonnage is based on the maximum manufactured or imported volume in any given year from 2016 to 2018.
Step 3：检查您的物质是否处于范围内，如果是Korean Existing Chemicals List (KECL); if not, your substance will be considered new.
K-REACH is a Multistage Process
如REACH，K-REACH是一个多级过程，具有不同的截止日期和信息要求，具体取决于进口或制造的物质的量。根据K-REACH，外国制造商在韩国未注册办事处的办事处需要任命韩国的代表（或）提交通知和注册。
步骤4: Establish the pre-notification and registration requirements for your substance.
第5步: Find and contract an OR if you need one.
第6步：仔细计算最大吨位，以确定该吨位频段的信息需求。
Designated or Priority Existing Chemicals
K-REACH具有相似的信息要求，尽管使用读取和定量结构 - 活动关系（QSAR）用于放弃一些动物研究的模型并不广泛接受K-Reach。
第7步:确定你所有用途的物质,因为这will drive the exposure scenarios and risk assessment. You may need to consult downstream users.
第8步: Conduct a data gap analysis to identify information you need to source, or the testing plans you need to carry out.
Planning Your Registration
Like REACH, K-REACH requires a single dossier to be submitted for each substance. This means that, as in Europe, companies producing chemicals containing the same substance must work together in a structure called a Chemical Substance Information Communicative Organization (CICO), which is similar to the EU Substance Information Exchange Forums (SIEFs). The CICO provides a framework, which enables the effective sharing of data and costs.
第9步: Characterize your substance in detail.
第10步：通过K-REACH IT系统查找其他注册人，并考虑如何在CICO中与他们合作。您可能需要考虑您商业上的物质对您的重要性，并且注册人是否将以同样的方式优先考虑该物质。
Step 11: Decide who will act as lead registrant.
Step 12：仔细签订数据访问，检查数据质量（如果可能）并意识到使用限制。
Summary
K-REACH is closely aligned with REACH regulation. The two have similar processes and evaluations. Although K-REACH relies more heavily on animal data. The pre-notification period for existing substances imported or manufactured at ≥1 tonne/year runs between January 1, and June 30, 2019. After this, submissions deadlines vary by tonnage band. Joint submissions are the norm, with registrants working together in CICOs.
需要k-adger注册的许多物质已经通过refler在欧盟注册。因此，达到档案可以是数据来源，尽管可能需要大量的返工来对齐任何K-REACH提交与韩国法规。
K-REACH MILESTONES在立法中
- Pre-notification for existing substances manufactured or imported at ≥1 tonne/year was required by June 30, 2019
- 现有物质有三个吨位，具有不同的注册截止日期
- Data requirements for registration increase with increasing tonnage
- 510优先现有化学品的登记期限为2018年7月1日
- Joint submission is mandated in most cases, with registrants working together as part of a CICO with a lead registrant
- Manufacturers or importers based outside Korea must appoint an OR to submit and manage substance registration
通过K-REACH获取您的产品需要长期规划，监管洞察力和不断关注到达您的最终目标。有关K-REACH的更多信息。阅读我们的白皮书，“如何为K-Reach立法做准备。”
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