Voortgang toetsingskader

Het Ctgb stelt regelmatig een overzicht op van de ontwikkeling van Europese guidances (zowel inhoudelijk als procedureel) en de ontwikkeling van Ctgb-beleid.

Inhoudelijk toetsingskader gewasbeschermingsmiddelen in ontwikkeling

Per aspect verwachte implementatiedatum en een korte toelichting   

TK-element gewas

Aspect

Implementatiedatum

Gremium/toelichting

1. Extrapolatie document sierteelt gewassen – herziening WZH

Oktober 2018

Betreft uitvoeringsregel

2. Grondwater Atlas MIL Eind 218

Betreft uitvoeringsregel

3. Guidance on MRL setting for honey

RES

Eind 2018

SCoPAFF residuen

4. Stapeling middelen op basis van dezelfde werkzame stof

Onbekend

Betreft uitvoeringsregel

5. Commission implementing Regulation amending Implementing Regulation (EU) No 844/2012 in view of the scientific
criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605
Onbekend SCoPAFF

6.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 - herziening

FCE Onbekend SCoPAFF
7. Guidance document on the Evaluation Efficiency of Residue Analytical Methods: SANTE/10632/2017 FCE Onbekend SCoPAFF

8. Guidance Document for predicting environmental concentrations of substances in soil

MIL

Onbekend SCoPAFF
9. Guidance document on the establishment of the residue definition for dietary risk assessment: SANTE/11644/2017

RES

Onbekend SCoPAFF

10. Guidance document on the authorisation of plant protection products for seed treatment SANCO/10553/2012 rev.0

Onbekend SCoPAFF
11. Commission working document on risk management aspects related to the assessment of cumulative exposure Onbekend EFSA
12. Standard on insecticide co-formulated mixtures – herziening WZH Onbekend EPPO
13. OECD, Draft Guidance Document on the Fish Bioaccumulation Test - herziening

MIL

Onbekend OECD
14. EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees). MIL Onbekend Europese Commissie
15. Guidance Document secondary metabolites microorganisms TOX Onbekend EU WG biopesticides
16. Guidance Document on amphibians and reptiles MIL Onbekend EFSA
17. Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age RES Onbekend EFSA
18. Technical Guidelines on the structure of the Biological Assessment Dossier - herziening

WZH

Onbekend EFSA
19. Specific Protection Goals

MIL

Onbekend Europese Commissie
20. Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals Onbekend EFSA

Procedureel toetsingskader gewasbeschermingsmiddelen in ontwikkeling

Per aspect verwachte implementatiedatum en een korte toelichting

TK-element gewas

Implementatiedatum

Gremium/toelichting

1. Template to notify intended zonal applications under Article 33 and Article 43 of Regulation (EC) No 1107/2009
- herziening

Oktober 2018 SCoPAFF
2. Procedures for routine MRL setting under Regulation (EC) No 396/2005  procedures Eind 2018 SCoPAFF residuen
3. Technical guidelines on the presentation and evaluation of plant protection product dossiers in the format of
a (draft) Registration Report: SANCO/6895/2009 rev 2.2- herziening

Wacht op implementatie van
GD on Zonal Evaluation, Mutual
Recognition Withdrawal and Amendment

SCoPAFF
4. Technical Guidelines on Data Protection according to Regulation (EC) No 1107/2009: SANTE/10407/2018 Rev. 2
- herziening
Onbekend SCoPAFF

5.  Guidance Document on Zonal Evaluation, Mutual Recognition Withdrawal and Amendment of Authorisations
under Regulation (EC) No 1107/2009: SANCO/13169/2010 rev. 11- herziening

Onbekend SCoPAFF

6. Guidance document on the Renewal of authorisations according to Article 43 of
Regulation (EC) No 1107/2009 SANCO/2010/13170 – rev. 14, jan 2018 – herziening

Onbekend SCoPAFF
7. GD minor use (procedureel en inhoudelijk) Onbekend Horizontal Expert
Group minor uses
8. Co-formulanten Verordeningen Draft COMMISSION IMPLEMENTING REGULATION setting out detailed rules for
the implementation of Article 27 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council
concerning the placing of plant protection products on the market Draft COMMISSION REGULATION modifying
Annex III of Regulation (EC) 1107/2009 of the European Parliament and of the Council concerning the placing of plant
protection products on the market
Onbekend SCoPAFF
9. GD openbaarmaking - nieuw Onbekend WG
openbaarmaking
10. Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation)
– herziening
Onbekend PSN
11. Guidance document on rules for revision of assessment reports - herziening Onbekend PAI
12. Guidance document on the assessment of new variants of approved active substances Onbekend EFSA
13. Guidance Document on significant and non-significant changes of the chemical composition of authorised plant protection products under Regulation (EC) No 1107/2009 (SANCO/12638/2011, rev. 2) -herziening Onbekend EFSA
14. Guidance on preparing good quality dossiers and Assessment Reports Onbekend EFSA
15. Guidance on data matching Onbekend EFSA

Toetsingskader voor zowel gewasbeschermingsmiddelen als biociden

TK-element

Implementatie-

datum  

 Gremium /
 toelichting

a. 11e ATP CLP  2018 Europese Commissie
b. Uitvoeringsregels semiochemicals en lokstoffen in de toelating    2018 Betreft uitvoeringsregel
c. Guidance on labelling and packaging in accordance with Regulation No 1272/2008 July 2017 version 3.0  2018 Europese Commissie
d. Invulling meldplicht toelatings-houder van nieuwe informatie, die relevant is voor de toelating Eerste helft 2019 Betreft uitvoeringsregel
e.Herziene drinkwaterrichtlijn, biocide en GBM Onbekend Europese Commissie,
nog in ontwikkeling
f. Wijziging Besluit en Regeling gewasbeschermingsmiddelen en biociden Onbekend Betreft nationaal beleid,
nog in ontwikkeling