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.
Chemical Daily talked to SCC about its past developments and future plans in view of the current regulatory environment
Date: 18 November 2019
Having been on the market since 1936, the Chemical Daily is Japan’s leading chemical industry newspaper with a daily circulation of 100,000 readers and its overseas offices in Shanghai, Singapore and Bangkok. The Chemical Daily interviewed Dr Pistel asking about SCC’s company foundation in Japan and its plans for the future in light of recent regulatory developments in the chemical industry. To read the original interview in Japanese and its English translation, please follow this link.
India to Include Biostimulants into the Fertiliser Act 1985
Date: 8 November 2019
The Indian government intends to include biostimulants into the Fertiliser (Control) Order, 1985. For this reason, it has recently issued a draft guideline on biostimulants, making it available to public consultation. The guideline defines biostimulants as “compounds, substances and products including microorganisms whose functions when applied to plants/seeds/ rhizosphere is to regulate and enhance a crops physiological processes independent of the products nutrient contents to improve input use efficiency, growth, yield, quality and/or stress tolerance. The bio stimulants may include products of plants /animals or microbial origin”.
UBA requests Supreme Court review of judgments on pesticides
Date: 25 October 2019
On 10 September 2019, we already published an article on our website concerning the Judgment of the Administrative Court of Braunschweig on admissibility of biodiversity areas. To view the article, click here.
Now the UBA commented on 21 October 2019 (Press release by UBA - Nr. 38/2019), on the judgments of the Administrative Court in Braunschweig regarding the temporary approval of plant protection products.
At the end of last year and at the beginning of this year, the BVL approved several plant protection products and limited these approvals until 31 December of this year. The limitation was based on disputed application restrictions for the protection of the biodiversity of the UBA in its comments on the evaluation of plant protection products.
The Federal Environmental Agency (UBA) states in their recent release that, three recent judgments of the Administrative Court of Braunschweig deny German authorities the right to fully assess the real impact of pesticides on the environment and to prescribe protective measures. UBA considers it imperative that the competent authority (BVL) file an appeal against the judgments.
Maria Krautzberger, President of UBA states:
„Should the judgments of the Administrative Court in Braunschweig become final, we will cease the protection of biological diversity in the authorisation procedure of plant protection products….
It is therefore essential that these legal issues be resolved by the Higher Administrative Court in Lüneburg.”
Click here to view the UBA newsletter in German.
The current state of biopesticide and fertiliser regulation in the EU
Date: 14 October 2019
In the interview for the 2019 Biologicals Special, Dr Lars Huber, Head of Biorationals, Fertilisers & IPM, speaks about the recent developments in the biopesticide and fertiliser markets and the effects they have on the industry. He also touches upon the current problems and identifies main sticking points which need further improvement. He provides advice and offers an outlook for possible future shifts. To read the article, please follow the link.Dr Lars Huber, Head of Biorationals, Fertilisers & IPM
K-REACH: Time to Join the Consortia
Date: 11 October 2019
CICO (Chemical substance Information Communicative Organizations) is opened since 07.10.2019 on K-REACH portal. Future registrants are encouraged by MoE (Ministry of Environment) to join their relevant consortia still within this year and to indicate whether they want to be an active member or rather to be a volunteer as LR (Lead Registrant). The webpage is all written in Korean. Attached you will find the guidance for using the Korean CICO.
If you need further information on the procedure, please contact us.
Call for candidates to enter the EC medical device expert panels
Date: 8 October 2019
Currently, medical device companies fail short to fully implement the MDR (EU) 2017/745 due to several open decisions, missing common standards and guidance documents. However during September this year, some new information about the expert panels has become available.
According to Article 54, the expert panels must be consulted for assessment of the clinical evaluation reports for certain class III and class IIb devices. In addition, the expert panels are also assigned to contribute to the development and maintenance of the common standards (CS), international standards as well as guidance documents, e.g. for clinical evaluations. They will also provide opinions in response to inquiries by manufacturers according to Article 61(2) and offer advice to notified bodies and member states.
With respect to in vitro diagnostic medical devices, the expert groups should also be consulted in cases where no CS are available for class D devices and where it is also the first certification for that type of device.
New Head of Agrochemicals and Biorationals at SCC from 1 October 2019
Date: 1 October 2019
We are glad to announce to you that Dr Bernd Brielbeck will succeed Dr Albrecht Heidemann as the Head of the “Agrochemicals & Biorationals” Business Unit from 1 October 2019.
Dr Heidemann has filled this responsible position since joining the SCC in 1994. He will retire on 1 October 2019, after which Dr Brielbeck will follow him as Head of Business Unit to ensure the continuity and continued competence you expect from SCC.
Dr Brielbeck has been in the company since 2001 and has been working in the Business Unit of Dr Heidemann ever since he started, filling the responsible position of Group Leader for the Regulatory Group. Dr Brielbeck is well versed in the particularities of regulatory affairs of plant protection products. To many of you, he is personally known through meetings or presentations on the various aspects of plant protection regulatory affairs.
We are certain that Dr Brielbeck has accumulated all the necessary and detailed experience to fill his new responsible position. We are very happy that we were able to fill this position with an experienced SCC staff member, who has the necessary intimate knowing of the needs of our clients and the regulatory field that Dr Brielbeck has worked on for so many years already.
We thank Dr Heidemann for his services and wish him all the best for his future endeavours in his retirement.
New Head of GLP and Regulatory Archives at SCC from 1 October 2019
Date: 1 October 2019
We are pleased to announce to you that Dr Karin Lauber will be the new Head of GLP and Regulatory Archives and the new Regulatory Group Leader at Agrochemicals and Biorationals as from 1 October 2019.
As Dr Brielbeck will follow Dr Heidemann as Head of Agrochemicals and Biorationals, Dr Lauber will succeed Dr Brielbeck in his former positions.
Dr Lauber has been in the company since 2009, starting in the residue group of the Regulatory Science business unit. She moved to the regulatory group of Agrochemicals and Biorationals business unit in 2011. Many of you already know her through meetings, expert discussions and/or presentations at different conferences.
Ensuring the continuity and continued competence you expect from SCC, we are very glad to fill these positions with a qualified SCC staff member.
With strong commitment, hands-on experience in the regulatory field of plant protection products and profound understanding of the needs of our clients, we are certain that Dr Lauber has full qualifications to fill her new responsible positions and further develop a trustworthy relationship with our clients and partners.
Judgment of the Administrative Court of Braunschweig on admissibility of biodiversity areas
Date: 10 September 2019
The BVL has recently published the judgment of the Administrative Court of Braunschweig on the admissibility of biodiversity areas:
"The Administrative Court of Braunschweig allowed the claim of two pesticide manufacturers on September 4. The manufacturers had complained that their pesticides were only approved by the Federal Office of Consumer Protection and Food Safety (BVL) until 31 December 2019.
Normally, the BVL sets the duration of the authorisation to be valid for the duration of the approval of the active substance plus one year. The reason for the shortened expiry date for the authorisation in the two cases mentioned above were the controversial application requirements for biodiversity protection required by the Federal Environmental Agency (UBA) from 2020 onwards.
The judgments now oblige the BVL to grant authorisations for the mentioned plant protection products beyond the previous expiry date of the registration on 31 December 2019.
Furthermore, according to the judgments, the approval must be extended with its current content and not be provided with the application provisions for biodiversity requested by the Federal Environmental Agency.
The Administrative Court justifies this decision by stating that it is currently not possible to take into account unacceptable effects on biodiversity, as there is a lack of scientific methods approved by the European Food Safety Authority (EFSA) for assessing these effects. Also, neither Regulation (EC) No 1107/2009 nor the Plant Protection Act would provide a legal basis for the adoption of compensation areas.”
To read the original publication in German, please follow the link to the BVL website.