SCC GmbH – Newsletter 2019

Newsletter 2019

SCC Newsletter, Vol. 19, No. 5, December 2019

LOOKING FORWARD TO 2020 – REGULATORY NEWS

Date: 20 December 2019

This issue features relevant information on agrochemicals (e.g. parallel trade), biocides (K-BPR), chemicals (e.g. nanoforms and registration dossiers), medical devices (class 1 devices), and regulatory science (non-dietary exposure model).
For more details, please refer to the corresponding articles.

With regard to the current situation in the UK, Britain's Conservatives won their biggest majority since the 1980s in the December election. As a result, they will have a mandate to take the UK out of the EU, presumably at the end of January 2020.

Do not forget to take a look at our calendar to find out where you can meet with SCC experts to improve your skills on biocides.

We would love to hear what you think about the SCC newsletter, so please do not hesitate to share your feedback and comments with us.

Please contact us by email at This email address is being protected from spambots. You need JavaScript enabled to view it..

Date: 7 November 2019

We would like to inform you that Dr Bernd Brielbeck succeeded Dr Albrecht Heidemann as the Head of the Agrochemicals & Biorationals business unit on 1 October 2019. We thank Dr Heidemann for his services and wish him all the best for his future endeavors during his retirement.

Furthermore, Dr Karin Lauber was appointed as new Head of GLP and Regulatory Archives and new Regulatory Group Leader at Agrochemicals and Biorationals in October 2019.
For more details, please refer to the corresponding articles.

In this newsletter you will also find relevant information on agrochemicals, medical devices, and regulatory science.

Do not forget to take a look at our calendar to find out where you can meet with SCC experts to discuss your needs and find answers to your questions on scientific and regulatory issues.

We would love to hear what you think about the SCC newsletter, so please do not hesitate to share your feedback and comments with us.
Please contact us by email at This email address is being protected from spambots. You need JavaScript enabled to view it..

Date: 22 August 2019

IMPORTANT UPDATES ABOUT REACH, K-REACH, K-BPR AND MEDICAL DEVICE REGULATION

This special edition of the SCC Newsletter focuses on recent news relating to (EU) REACH, K-REACH, K-BPR and Medical Device Regulation.

Discipline by all stakeholders in the chemical registration process is becoming more important than ever before, given that REACH will impose close coherence with stringent timelines for dossier updates, new requirements for nanomaterials, and also much more precision and consistency vs. the mandatory information requirements for dossier content. And just to repeat: ECHA is significantly ramping up its level of dossier evaluations, forcing manufacturers, importers and Only Representatives to constantly keep their dossiers up to date.

Brexit is another big challenge for the chemical industry that clearly requires high attention and good proactive planning.

The newsletter also provides high-level summaries of the most important provisions for the registration of chemicals and biocides in South Korea.

Last but not least, the newsletter gives an overview of the ongoing implementation of the new EU Medical Devices Regulation (MDR) with several significant changes.

Do not forget to take a look at our calendar to find out where you can meet with SCC experts to discuss your needs and find answers to your questions on scientific and regulatory issues.

Date: 16 May 2019

REGULATORY NEWS

Please find below an overview on the topics listed in the current newsletter:

MEDICAL DEVICES: new regulatory group in our Chemicals division
New SCC spin-off: ‘SCC LEGAL Law Firm’
REACH obligations for non-approved plant protection products (PPPs)
AGROCHEMICALS: Article 43, registration of adjuvants
CHEMICALS/REACH: REACH data compliance, international registrations
REGULATORY SCIENCE: Appendix E of the ECHA/EFSA guidance on ED, 5th International Fresenius Conference
"Worker, Operator, Bystander and Resident Exposure and Risk Assessment” (Dec. 2018)

Moreover, some information on Brexit is given; international companies that operate in EU/UK markets must be extremely well prepared and highly proactive if they want to remain successful and well positioned in their industries.

Do not forget to take a look at our calendar to find out where you can meet with SCC experts to discuss your needs and find answers to your questions on scientific and regulatory issues.

We would love to hear what you think about the SCC newsletter, so please do not hesitate to share your feedback and comments with us. Please contact us by e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it..

Date: 27 February 2019

BREXIT: ACT NOW TO MAINTAIN MARKET ACCESS AND SUPPLY CONTINUITY!

Whereas the political uncertainty about the withdrawal agreement and about the Brexit overall seems to continue forever now, we urge our clients not to wait until the last week in March 2019 with decision making in the desperate hope of getting final clarity about the future contractual agreements between all the parties involved. If a ‘no deal’ scenario was to materialize that late in the process, severe supply and market disruptions would be impossible to avoid. We thus strongly encourage you to prepare for the worst and secure your business critical supply relations for chemical substances and products while continuing to hope for the best.

The SCC key contact for all Brexit queries is This email address is being protected from spambots. You need JavaScript enabled to view it., Head of Chemicals/REACH, Consumer Products, Cosmetics, Feed & Food Additives.