Newsletter May 2022

The Russian invasion of Ukraine surprised almost all Western European countries. Who could have imagined that something like this would happen in 2022 in Europe? In newspapers and on the internet, social media, radio and television we are witnessing horrors that we could have hardly imagined for years. Millions of Ukrainians have now fled their country. And in the Netherlands – due to our dependence on Russian gas, oil and coal – we are also feeling the effects of the war, of the sanctions, of rising energy prices and of sudden inflation.

But there is also another effect. Since the invasion began, exports of food and fertiliser from Russia and Ukraine have plummeted. The shelves with sunflower oil in our supermarkets are suddenly empty, and there are major concerns about grain shortages – especially in Africa. The intricate interconnection and interdependence of global trade flows has suddenly become clear. And we now see what can happen if one country becomes isolated and disappears from the chain.

This interconnection and interdependence is also apparent in the transition to more a sustainable agriculture sector: we are not alone in that process either. The choices we make in the Netherlands, such as whether or not to reduce numbers of livestock, also affect trade flows. Due to food security concerns, Copa and Cogeca (the European associations for agriculture and horticulture), are calling for postponement of the Farm-to-Fork strategy and to prioritise food security above sustainability. But is this really necessary? The transition requires so much time – can we afford to delay this process even further?

The economic director of the World Food Programme recently cited research from Wageningen University indicating that there should be no worldwide food shortage for the next six months. In any case, the current situation illustrates very clearly that the global economy is a finely-meshed web that is vulnerable to disruption. Due to environmental and climate concerns, the transition to sustainable agriculture cannot wait any longer. However, the magnitude of the task is becoming increasingly clear, because a new balance in trade flows will also have to be found. And in the end, food security and sustainability have to go hand in hand!

Ingrid Becks

Secretary/Director

A competent authority outside the Netherlands has informed us that fake invoices/payment reminders are being emailed to their contacts. We have not yet received such warnings, but please note when the Ctgb sends an invoice or payment reminder, we always specify your application number. Moreover, the invoices are always sent from the email address Finance@ctgb.nl. Please check this carefully and if you are in doubt contact the Finance team of the Ctgb.

In consultation with authorisation holders and European partners, the Ctgb is developing measures to prevent phosphine poisoning during transport. Proposals for these measures, such as a ban on the use of phosphine during transport, are now taking shape. Read more in our topic on phospine.

Authorisation holders of plant protection products will soon receive an e-mail from the Ctgb about the annual notification. According to Article 56 of VO 1107/2009, authorisation holders of plant protection products are required to notify the Ctgb annually if new information has become available about their product or the corresponding active substance regarding reduced efficacy, unacceptable effects on plants or development of resistance. Even if no new information has become available, authorisation holders are still obligated to notify the Ctgb about this. For details see the page on the website.

Annual notification by the authorisation holder

For dossiers submitted from 1 May 2022, the revised guidance for the assessment of the relevance of metabolites in groundwater applies (Sanco/221/2000 – rev.11; 21 October 2021). The main amendment is that for metabolites the following genotoxicity endpoints should be addressed:

• gene mutation (in both bacterial and mammalian cells)
• structural chromosomal changes (clastogenicity)
• numerical chromosomal changes (aneugenicity)

A combination of an Ames test, an in vitro Mammalian Cell Gene Mutation Test (tk or hprt locus) and an in vitro micronucleus test fulfils the requirements to cover the genetic endpoints listed above. In addition, the new guidance provides a further explanation of how to deal with situations where the results of the studies are equivocal or inconclusive; and in the case of positive outcomes. In addition, a clarification has been added on how to assess metabolites formed by micro-organisms (which are active substances).

On 1 November 2021, the ‘Guidance document for the generation and evaluation of data on the physical, chemical and technical properties of plant protection products under Regulation (EC) No. 1107/2009’, SANCO/10473/2003 – rev. 5, entered into force. This covers the assessment of all requirements in Regulation (EU) No. 284/2013 for the physical, chemical and technical properties of plant protection products. Frequently used elements include the overviews of mandatory endpoints per formulation type, whether or not required before and after storage, overviews of test criteria and extrapolation rules for packaging materials. Additionally, the guidance document provides more information on testing for classification and labelling.

The implementation of the document in the EU puts an end to the ambiguity surrounding the use of the ‘UK/CRD Guidance’. In contrast to the UK/CRD Guidance, the new SANCO guidance document provides EU-wide support for applicants and Member States in the respective preparation and assessment of a draft Registration Report (dRR) for product applications.

On 1 April, the Evaluation Manual was updated with the following changes:

• EU part Chapter 4 Human toxicology; mammalian toxicity dossier version 2.5; April 2022: Updated to the revised version of Guidance document on the assessment of the relevance of metabolites in groundwater (Sanco/221/2000 – rev.11 21 October 2021)
• EU part Chapter 2 Physical and chemical properties version 2.3; April 2022: Inclusion of the guidance document for chemical and technical properties of plant protection products SANCO/10473/2003 rev. 5 (applicable from 01-11-2021)

On 1 April, the Evaluation Manual was updated with the following changes: NL transitional legislation part version 3.2; April 2022: Information added on use and reference to standard SPC sentences.

Evaluation Manual

ECHA has published recommendations on preparing a summary of product characteristics (SPC) for biocidal products and biocidal product families. They were developed to help applicants and Member State competent authorities prepare a clear and comprehensible SPC which follows the requirements of the Biocidal Products Regulation (BPR). The document compiles agreements from the Coordination Group, Biocides competent authority meetings and Biocidal Products Committee meetings and is applicable to single products and biocidal product families.

See Recommendations on preparing a Summary of Product Characteristics (SPC) for single biocidal products and biocidal product families.