EUROPE: publication of the 12th ATP to CLP

The 12th adaptation to technical progress (ATP) of the CLP Regulation was published on 28 March 2019.

This amends Annexes I to VI to take account of the sixth and seventh revised editions of the Globally Harmonized System (GHS) of classification and labelling of chemicals. In particular, these revisions of the GHS introduce a new hazard class for desensitised explosives and a new hazard category, pyrophoric gases, within the hazard class flammable gases.

Other changes include adaptations to the criteria for substances and mixtures which in contact with water emit flammable gases, the generic cut-off values; the general provisions to classify aerosol forms of mixtures; and the detail of the definitions and classification criteria as appropriate for the hazard classes explosives, flammable gases, flammable liquids, flammable solids, acute toxicity, skin corrosion/irritation, serious eye damage/eye irritation, respiratory and skin sensitisation, germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific target organ toxicity and aspiration hazard.

In addition, amendments are introduced to some hazard and precautionary statements.

This Regulation shall apply from 17 October 2020.

 

To download:

Commission Regulation (EU) 2019/521 of 27 March 2019 amending, for the purposes of its adaptation to technical and scientific progress Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

Europe: Update of EC Guidance on Generating and Reporting Methods of analysis (SANCO/3030/99 rev.5)

Revision 5 of the Guidance on Generating and Reporting Methods of analysis (SANCO/3030/99 rev.5) was published on 22.03.19. This general update is based on the EU Member States and EFSA comments, derived from experience with application. This revision also aims to comply with the Regulations (EU) No. 283/2013 and 284/2013 requirements, which address the development of analytical methods required for pre-registration and for post-registration control and monitoring purposes, and to improve a common understanding on the required validation data.

This revision will entry into force for dossiers submitted on or after 01.10.2019.

 

To download:

SANCO/3030/99 rev.5 – Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013.

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

EUROPE – EFSA: Update of the Pesticide Residue Intake Model 3 (PRIMo rev. 3.1)

EFSA has released the revision 3.1 of the Pesticide Residue Intake Model. The following modifications were introduced:

  • A new spreadsheet was added to facilitate the conversion of MRLs derived from the European Commission database in a format compatible with PRIMo;
  • Correction of a number of large portion consumption data;
  • Correction of unit weight data;
  • Correction of TMDI calculation;
  • Correction of the calculation of the threshold residue in processed products (IESTI case 2a and 2b);
  • Editorial modifications.

A comparison of old and new versions indicates that the revisions impact the acute risk assessment, for several commodities, but not the chronic risk assessment.

To download:

Pesticide Residue Intake Model – EFSA PRIMo revision 3.1 (update of EFSA PRIMo revision 3), EFSA Supporting publication 2019:EN-1605

EFSA PRIMo revision 3.1 (spreadsheet)

See also our previous articles:

EUROPE: New version of the Pesticide Residue Intake Model (PRIMo rev. 3)

Lynxee consulting’s team is at your disposal to answer your questions.
Contact us! http://lynxee.consulting/en/contact/

EUROPE: ECPA Conference 22-23 May 2019

Lynxee consulting will participate to the 6th Annual Plant Protection Regulatory Conference organised by ECPA with the support and participation of ECCA to be held on 22-23 May 2019. This year the conference is organised in cooperation with the 2019 IUPAC Congress and will be held in Ghent (Belgium).

For this new edition, the interventions will be provided by representatives of Member States, EFSA, DG SANTE, Industry and others.

It will give insights of latest regulatory developments (policy, REFIT), update on a.s. evaluation process, new trends and opportunities for the future and will close with a zonal workshop.

The whole team of Lynxee will attend this conference: Emilie Vianay, Karine Mavet, Florence Dupeuble, Adrien Margerit.

Please do not hesitate to contact us to arrange a meeting: http://lynxee.consulting/en/contact/

For more information:  2019 ECPA Regulatory Conference