Turkey amends its KKDIK regulation
Date: 4 December 2019
On 29 November 2019, the Turkish authorities published the Regulation No 30963 amending KKDIK, its chemicals regulation. The amendments involve:
- Additional definitions in Article 4
- A new entry to Annex-17 restricted substance list
- Introduction of a new sub-annex, Annex-XI, to Annex 17
Introduction of OR function under K-BPR
Date: 29 November 2019
Under K-BPR law, there is no function of Only Representative (OR) until now. This leads non-Korean companies, which have no branch office in Korea, to give all the information requested by authorities to their importers for notifying their active substances.
According to recent information from NIER (National Institute of Environmental Research), the OR concept will soon be extended to K-BPR under Korean civil law. This means that foreign companies can appoint consulting companies with a business registration certificate in Korea as their OR, not only for K-REACH but also for K-BPR.
No English translation for K-BPR
Date: 28 November 2019
According to recent information from NIER (National Institute of Environmental Research), the Korean government has no intention to publish the K-BPR law in English.
Second Corrigendum of MDR (EU) 2017/745: Will class 1 devices get an extension?
Date: 27 November 2019
On 25 November 2019, the Council of the European Union published a second corrigendum to MDR (EU) 2017/745. The corrigendum includes overall 12 edits, corrections or additions, changing Article 78, 84, 88, 120, 122 and Annex I and III.
The most significant change affects class I medical devices, for which the conformity assessment procedure requires the involvement of a notified body. Such devices, for which the declaration of conformity was drawn up prior to 26 May 2020, could be placed on the market or put into service until 26 May 2024. This addition is suggested to Article 120 paragraph (3), which was previously only related to devices that already had been certified by notified bodies. In addition, Article 120 paragraph (4) should be modified to include all products related to paragraph (3). This second change would effectively allow these devices to be made available on the market and put into service until 26 May 2025. The change applies to class I devices, which are sterile, include a measuring function, or are reusable surgical instruments.
Start action to prepare your joint submission under K-REACH
Date: 26 November 2019
The Korean Environment Corporation informed SCC that the companies that have already joined consortia do not need to wait for further potential members. They should start internal communication with other members to prepare the registration of 1000 tonnage under K-REACH.
In order to prepare a joint submission, consortium members have to decide on the Lead Registrant (LR). Potential candidates for LR should inform to other consortia members of their intentions, voting date and its duration at least 3 days before the LR election. When all the members have agreed on the election, the potential LR needs to activate a voting function on the CICO website for the respective consortia. Once it is opened, the consortia member can vote.
For the substances in the nanoforms, it is recommended to set up a separate nanomaterial* consortium, even though nanomaterials might have the same CAS number as the equivalent materials without nanoscale features. The MoE (Ministry of Environment) recommends producers and importers of nanomaterials to join the nanomaterial consortia on the CICO webpage. (See our news on CICO dated 11 Oct. 2019)
*According to the paragraph 7 article 2 of presidential decree of K-REACH, nanomaterials are described as:
- 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm, or
- fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm.
List of notified existing active substances under K-BPR is now released
Date: 21 November 2019
On 18 November, the Korean government published the list of notified existing active substances. The list contains the names of the notified active substances, their CAS numbers, their deadlines and the notifiers. Through this list, you can learn whether your notification was successful. If you cannot find your company’s name under the substances which you notified, there is still the possibility to send a corresponding note to the Legislation supporting center or the MoE (Ministry of Environment) by 5 December.
Even if you missed the notification deadline of 30 June 2019, this means if you have not notified at all, you still have the possibility to submit a notification by 11 December 2019. The final version of the list will be released after that.
From 1 January 2020, the active substances have to get approval before being produced in or exported to Korea, unless they have been successfully notified so that the grace period applies. Therefore, don’t miss the last chance to notify your active substances in order to use the advantage of the grace period.
You can find the mentioned list here. Please note, however, that the information on the list is written in Korean. Nevertheless, you will be able to find the name of your notified active substance (in English) and its CAS number.