KKDIK regulation now moving into registration phase: important updates on the Lead Registrant selection

Date: 23 February 2021

With the end of the pre-registration phase for KKDIK (‘Turkey REACH’) on 31 December 2020, full attention has now shifted to the actual registration phase, a 3-year window until 31 December 2023.

The Turkish Ministry of Environment and Urbanization (MoEU) recently published a number of updates to inform all actors in the supply chains on important details for the next phase.

Companies that consider becoming Lead Registrant (LR) for a pre-registered substance should clarify their intention soon and be ready to communicate their position with other SIEF members in the coming weeks. The Lead Registrant selection process has started and Lead Registrant candidates need to approach the other SIEF members for acceptance of the LR role. While LR voting is not compulsory, a voting module will be integrated on the SIEF page for the selection of the Lead Registrant in case of SIEF disagreement. The declarations for the Lead Registrant will start on 1 March 2021, simultaneously with the integration of the voting module in the KKS system.

New EU Fertiliser Regulation – notifying body for Germany and Nando

Date: 16 February 2021

The new EU Fertiliser Product Regulation 2019/1009 of the European Parliament and of the Council of 5 June 2019 is intended to create harmonized conditions for the supply of fertilisers across the internal market and to define general principles for CE marking.

HSE is operating an independent PPP active substance renewal programme for Great Britain

Date: 12 February 2021

In its newsletter on 11 February, HSE informs about a PPP active substance renewal programme for Great Britain that is independent of the EU and in operation from 1 January 2021. You can find the list of active substances, their expiry dates and the relevant renewal application deadlines on the HSE website.

SCC GmbH strengthens its management and sets its course for the future with two new CEOs: Monika Hofer and Martin Weiser

Date: 4 February 2021

Dr Monika Hofer and Dr Martin Weiser joined the management board of SCC Scientific Consulting Company on 1 January 2021.

Monika Hofer is a chemist and toxicologist and has been in a leading position at SCC for more than 20 years. She has significantly contributed to the growth and success of our company in her role as Head of the Regulatory Science business unit and through her work as SCC's Vice President.

Martin Weiser is a pharmacist and pharmacologist and has gained extensive experience in a number of executive positions in the pharmaceutical industry, most recently serving as CEO of the German Medicines Manufacturers’ Association in Bonn.

Dr Friedbert Pistel, the Founder of SCC and its President since 1989, will step back from the company’s operational business by 31 March 2021 to become the Chair of the Pistel Family Foundation (Pistel-Familienstiftung).

As of 1 April 2021, the new management board will comprise Monika Hofer, Martin Weiser and Florian Pistel, who has been responsible for administration, finance and human resources since 2019.

In addition to the changes in the management board, SCC will be expanding its existing portfolio of regulatory services. Alongside its current services in the fields of agrochemicals, chemicals, biorationals, biocides, cosmetics, feed additives, GMOs, and environmental protection, the company will be expanding its pharmaceuticals and medical devices offering and also aims to focus on further international market expansion and innovative targets.

If you have any questions, please contact your partner at SCC.

SCC and GBK are cooperation partners offering consolidated expertise and bundled services

Date: 2 February 2021

GBK Logo

                                          SCC Logo

With the newly enhanced cooperation, SCC and GBK bundle their vast expertise in legal, environmental, health, safety and regulatory issues to offer their customers versatile and integrated services across the world.

SCC supports its international customers with cost-efficient tailored solutions for their scientific and regulatory needs in the fields of agrochemicals, and biorationals, fertilisers, chemicals and biocides, feed and food additives, food contact materials, cosmetics and consumer products, medical devices, pharmaceuticals and legal services (provided by SCC Legal).

GBK GmbH Global Regulatory Compliance, Ingelheim, is an international consulting company providing a hands-on expertise in the fields of environment, health and safety to their more than 1,250 global customers in the chemical, food, pharmaceutical and automotive industries. GBK’s core services include product-registration in chemical inventory lists in Europe, USA and Asia, EHS auditing and dangerous goods services, including worldwide EMTEL emergency phone service for hazardous materials transportations as well as seminars and trainings. For more information on GBK, please visit GBK’s website.

Transparancy Regulation: Practical Arrangements

Date: 15 January 2021

Following the Transparency regulation, EFSA has finally published the long expected Practical Arrangements. The arrangements are legally binding and intend to help interpreting and implementing the legal framework provided by the Transparency regulation. Currently, three Practical Arrangements are available on the EFSA homepage:

  • The Practical Arrangement on confidentiality sets out the rules how confidentiality can be claimed and how such claims will be assessed within the need to make data publicly available according to the Transparency regulation.
  • The Practical Arrangement on pre-submission phase and public consultations sets out time lines and proceedings for the newly established pre-submission advice phase and the notification of studies.
  • The Practical Arrangement concerning transparency and confidentiality stipulates proceedings for proactive transparency and confidentiality. Its Annex provides a list of items for which confidentially requests may be submitted and gives the legal basis for them.

All three Practical Arrangements contain important insights on how the Transparency regulation will impact the regulatory framework and the depended proceedings such as approval and renewal of active substances.

We are preparing further updates on this issue and will share them with you soon.

EU's Green Deal – a brief overview

Date: 13 January 2021

Our biorationals experts Dr Lars Huber and Dr Jasmin Philippi closely examined EU's Green Deal and its impact on the crop protection industry, taking a glance at recent regulatory developments, on the one hand, and agricultural practice, on the other. The full analysis can be found in the IHS Markit Top 20 issue 2020 or you can also download it here.