Circular Economy - EU Parliament approves new fertiliser regulation

Date: 28 March 2019

Yesterday the European Parliament adopted the new regulation laying down rules on the making available on the market of EU fertilising products and amending Regulations 1069/2009 and No 1107/2009 and repealing the existing EU fertiliser Regulation 2003/2003 with 582 to 38 votes (7 abstentions).

The new Regulation is an integral part of EU's Circular Economy Package, establishing EU-wide quality, safety and environmental criteria for EU fertilisers whereat not only inorganic fertilisers will be covered by this Regulation, but also organic fertilisers, soil improvers, liming materials and growing media, inhibitors as well as biostimulants.
The new Regulation will apply three years after entry into force. Considering the procedure following-up the vote by Parliament, the new Regulation most likely will apply from 2022 onwards.

For more information on the Regulation, please refer to the various articles on fertilisers and biostimulants in SCC’s news archive 2018.

Dr Lars Huber, Head of Biorationals, Fertiliser, IPM


CAC 2019 – China’s International Agrochemical & Crop Protection Exhibition in Shanghai

Date: 5-7 March 2019

On 5 March the new Shanghai International Expo Center opened its doors to the CAC trade show, world largest one-stop platform for global agrochemical business performers.
Alongside the exhibition, CAC 2019 offers a wide-ranging conference programme providing updates on latest developments in the global pesticide & fertilizer industry, exploring newest trends in seed treatment & bio-control technologies as well as focusing on regulatory challenges faced by the global crop protection industry today.
Dr Hans-Josef Leusch, SCC’s senior regulatory expert and director of strategic business development, is attending CAC 2019 and speaking at the 2nd CROs & CRAOs Expertise Sharing Conference in Global Agrochemical Industry on Microbial Biocontrol Agents in the EU: regulations, procedures and chances.

 Please visit SCC at booth N3A28, which we are sharing with our partner BIOREG. Hans-Josef looks forward to meeting you.
 
CAC 2019 CRO Conference Leusch

SCC's archives confirmed as GLP compliant

Date: 28 February 2019

SCC is proud to announce that its statement of GLP compliance was reissued.

As an independent test site in the national GLP Compliance Programme, we are inspected on a regular 3 year basis. Our contract archive was inspected on 24 October 2018 and the statement of GLP compliance according to the German Chemikaliengesetz, EU Directive 2004/9/EC and OECD Principles of GLP was issued on 18 February 2019 by the Landesamt für Umwelt, Mainz, Germany.


New Manufacturer Incident Report templates for medical devices available

Date: 13 February 2019

The European Commission has published a new Manufacturer Incident Report (MIR) template, which adopts the Medical Device Regulation MDR (EU) 2017/745. The new template replaces the form in MEDDEV 2.12/1 revision 8 annex 3 and has been restructured and extended in all sections.

Further to the reporting template, a detailed help text is provided, including the tables for the code selection as well as the .xsd files for implementation in the manufacturer’s databases before January 2020.

Click on the following links to download the files:


SCC launches a new regulatory group – Medical Devices

Date: 23 January 2019

Medical Devices Dr Alexander Theis

We are happy to announce that we have recently launched a new regulatory group within our Chemicals division to expand the range of our services to registration support for the medical devices industry.

The new group is headed by Dr Alexander Theis, a polymer chemist with a hands-on long-standing experience in the medical device industry.

 

Our services for medical devices currently include:

  • Offering support in product development and in-market compliance
  • Individual gap analysis in context of MDR (EU) 2017/745 requirements
  • R&D support
  • Providing guidance with regard to biological evaluation of medical devices in line with ISO 10993
  • Literature search and supply service
  • Clinical evaluation following Article 61 and Annex XIV MDR (EU) 2017/745 and MEDDEV 2.7/1 revision 4
  • Qualification and validation of production and quality control equipment and methods
  • Preparing Safety Data Sheets

UK releases further guidance on chemicals regulation in the event of a no-deal Brexit

Date: 23 January 2019

In light of recent events, the British government has published further guidance covering the legal requirements included in the Biocidal Products Regulation, Classification Labelling and Packaging and Prior Informed Consent regulations as retained in UK law, using powers in the EU Withdrawal Act 2018. To view the recent requirements in case of a no-deal Brexit, please download the following files:
Guidance on Biocidal Products Regulation (BPR)
Guidance on Classification Labelling and Packaging (CLP)
Guidance on Prio Informed Consent Regulation (PIC)

Constantly keeping your REACH dossiers up-to-date: this is NOT a ‘nice-to-have legal option’

Date: 17 January 2019

Recent communication by the EU Commission, ECHA, the BfR, and also by Cefic all emphasized the high importance for systematic REACH dossier updating by the registrants.

We have summarized the most important facts for you in one file which you can download here.

Don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it. learn more.


Implementing Regulation on registration updates

Date: 8 January 2019

In the course of the 28th Meeting of Competent Authorities for REACH and CLP (CARACAL) the European Commission published a document (CA/114/2018) regarding the scope of an Implementing Regulation on registration updates.

SCC has a lot of experience in preparing and updating REACH dossiers according to the current REACH requirements. In case you are planning to update your REACH dossiers we can provide you with support. Please get into contact with This email address is being protected from spambots. You need JavaScript enabled to view it..


SIEF / SIEF Agreements

Date: 7 January 2019


The EU Regulation on chemicals “REACH” (Regulation (EC) No. 1907/2006) stipulates that Substance Information Exchange Forums (SIEFs) had to be operational until 1 June 2018, the day after the last REACH registration deadline.
Nonetheless, the registrants of a substance are still bound by the obligation to submit the information on their substance jointly and as of 1 January 2019, co-registrants have to coordinate the reply to ECHA, and speak with one voice during the entire process if they receive an ECHA decision, due to testing proposal evaluation or incompleteness of their dossiers.


ECHA Accounts - new features

Date: 7 January 2019

ECHA has launched new services for users of ECHA accounts.
When you log into your ECHA account, you now have the possibility to link the substances that are important for you and your company directly to your ECHA account by selecting them from the "Search for chemicals" section.