Kaeltia

CHESAR (CHEmical Safety Assessment and Reporting) Platform is an application under development by the European Chemicals Agency (ECHA) to help companies carry out their chemical risk assessments and document them, serving both the REACH Regulation, where previous CHESAR versions were already used under this framework and, the Biocidal Products Regulation, where the use of this tool is totally new.

Version 1 will be released by mid-2024 (latest info from ECHA, CA-Dec23_Doc.7.2b).

CHESAR Platform will implement the same principles as CHESAR, as the aim is to have an assessment that is structured, harmonized, transparent, and easy to update. The tool will fully integrate EUSES models for environmental assessment, as well as ECETOC TRA models for workers and consumers.

For REACH substances, the tool will support registrants in performing their full chemical safety assessment (for both human health and the environment) and generating their chemical safety reports (CSRs), as currently incorporated in CHESAR.

For Biocides, it will enable initially the environmental risk assessment needed for both active substances and products. The possibility to extend the tool to the human health risk assessment for the active substance and the product will be assessed in the future, also based on the first application experience and the data availability in IUCLID format.

With regard to the environmental risk assessment of biocides, the tool development responds to the current gap in the risk assessment tool roadmap, caused by the fact that the last version of the EUSES software  (last updated in 2019) may not accommodate latest updates in emission exposure scenarios and modifications in biocide risk assessments as specified in the Technical Agreements for Biocides (TABs) , including the newly developed emission scenarios, any new Emission Scenario Documents or new guidance.

The intention is that the CHESAR Platform is meant to automatically re-use data on substance properties (if available) from IUCLID and use it as input values for the risk assessment. Once the assessment is finalized, the user could generate (part of) the draft assessment report directly from CHESAR Platform.

Steps and tentative timelines

• Pre-implementation phase – scientific changes – finalized
• Implementation phase – ongoing (almost 300 environmental emission scenarios are being gradually implemented into CHESAR Platform)
• Internal & External Testing phase – in preparation
• Release phase – in preparation: Version 1 of CHESAR Platform will be released in mid 2024 in ECHA Cloud Services, and as desktop application shortly after.

It is foreseen that the tool will be periodically updated (1-2 times a year) to accommodate the new developments on the exposure assessment and risk assessment fronts in biocides in particular, and whenever relevant, also REACH.

On the 13th, 14th and 15th of March, the 17th Plant Health Symposium took place in Seville, where, among others, the following regulatory topics, under the European and national scope, on Plant Health were discussed by representatives of our Authorities and the Industry:

• Dr. Tomás García, scientist at IEGD-CSIC and CEIGRAM, highlighted the importance of the concept “One Health” since the fact that human, plant, animal, and environmental health’s are linked, should not be underestimated and are affected by globalization, tourism, new pests and diseases, among other factors. Likewise, he considered that the legislation that affects products for the control of pests and diseases should be subject to risk-proportionated actions, since the precautionary principle is sometimes used disproportionately and without evidence to support certain measures. Finally, he concluded that the transition towards agroecology can only take place with the involvement of all actors in the supply chain.
• Richard Ramón, representative of the European Commission, focused his presentation on food security and its sustainability, highlighting 14 global megatrends, as the forces that will ultimately cause the change, among which we can mention climate change, degradation of the environment, the limitation of resources, the increase in consumption, among others. He raised the question about how we are going to increase agricultural production that is sustainable and referred us to the Canadian model that has focused its efforts on precision agriculture, biotechnology and digitalization, without a doubt, a model that is worth incorporating into our agricultural practices. He also highlighted the creation of an Observatory of the needs of the primary sector to address the changes that are necessary to avoid unfair practices that harm the sector.
• Valentín Almansa, General Director of Agricultural Production Health, began his speech with the news about the cancellation of the new proposal for the sustainable use of pesticides, a decision very close to the vote of the new European Parliament, and continued his presentation with the results obtained after 2 years of analysis of sales data of (bio)pesticides in Spain. He highlighted that the largest sale, which we could compare to use (there is no data on use, only purchases/sales), corresponds to fungicides and acaricides, to a lesser extent herbicides and insecticides and that this pattern is repeated in the different Regions.
• Emilio Rodríguez, representative of the EU Commission (JRC), commented on the relevance of the fact that, in a context of new emerging pests and diseases, we have fewer products to control them, which is why he focuses on the effort to achieve plant varieties with long-lasting resistance to these pests and diseases. To do this, he focused his presentation on the techniques that are being worked on such as cisgenesis and directed mutagenesis (CRISPR among others). He highlighted the pros and cons of gene modification in plant species, such as the lower use of phytosanitary products as they are more resistant varieties, but with a reduction in the yield of the crop that they are working to improve.
• Dr. José Luis Alonso, representative of the INIA-CSIC, focused his presentation on the integrated pest control as the best pest and disease control strategy, where all types of controls/strategies have a place, always starting with prevention with appropriate agro-practices, followed by products of more natural origin and ultimately, applying chemical control measures when previous therapies have not been effective. Regarding future legislative changes, he reported that they are working on an accelerated procedure for more natural products, something that has been demanded for years by the Biocontrol sector. Efforts are also focusing on the definition of Biopesticides so that, throughout Europe, the same type of products are referred to when this term is used, as well as extending the approval time for low-risk active substances to reduce bureaucracy to administration level. New guidelines will be published by the EU Commission on microbial consortia, RNA-based products, plant extracts, EPPO standards on low-risk risk assessments. For its part, EFSA is working on a new guide to select low-risk active substances from the initial phases, not like now when it is concluded during the process.
• Jacobo Herrero, representative of IBMA Spain, explained to the attendees the proposal that the Association will present to the new European Commission after the cancellation of the new sustainable use proposal where they request: a clear definition of Biocontrol, a working group to evaluate these requests of Biocontrol, eliminate the need to renew this type of products, grant provisional authorizations, make the extension of uses more agile and create a permanent group of evaluation experts.
• Camino García, president of AEFA, for her part, intends to bring to the new European Commission a simple, direct and practical proposal that allows Biocontrol products to be accommodated at the European level with more agility, like the previous speakers said, on the approval of Biocontrol and low-risk active substances, in addition to other procedures like, mutual recognition and parallel trade. In addition, like IBMA, they request a single European entity that evaluates this type of products. Since a modification of the current phytosanitary regulation is not possible, they propose a new legislation only for low-risk products.
• Mª Victoria de la Haza, representative of AEPLA, focused her presentation on some of the techniques and measures that we have at our disposal to reduce and/or mitigate the risks of products that may have certain toxicity for humans. She highlighted the importance of the MAgPIE project initiated in Florida in 2013 as well as the recent draft (March 2024) of the European Compendium to reduce exposure and risk during the use of pesticides and that, in addition, an EFSA guide is expected in the future also in this sense.

For more info about this event: CLIC HERE

The 17 Symposium Sanidad Vegetal (Plant Health) will take place in Seville on the 13th, 14th and 15th of March and KAELTIA Consulting will attend this Conference/Exhibition where Industry, Farmers and Authorities share their respective experience with the current regulatory issues and also show their respective concerns about the future of this sector.

You can find more information of this event at: www.fitosymposium.com

If you want to arrange a meeting with Dr Elisa Capellan at this event, please feel free to call at +34 626 789 777 or send an email at admin@kaeltia.com

Hope to see you there!

REACH+ requirements

According to the Fertilizing Products Regulation (EU) 2019/1009, “Where an EU fertilising product contains a substance or mixture within the meaning of REACH, the safety of its constituent substances for the intended use should be established through registration pursuant to that Regulation”.

Where the actual quantities placed on the market are lower than 10 tonnes per company per year, the information requirements determined by REACH for the registration of substances in quantities of 10 to 100 tonnes should exceptionally apply as a condition for use in EU fertilising products (REACH+).

Where the actual quantities of substances in EU fertilising products regulated by this Regulation are higher than 100 tonnes, the additional information requirements laid down in REACH should apply directly by virtue of that Regulation. The application of the other provisions of RREACH should also remain unaffected.

All substances incorporated into the EU fertilising product, on their own or in a mixture, shall have been registered pursuant to REACH, with a dossier containing:

(a) the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and

(b) a Chemical Safety Report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilizing product,

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to REACH or by points 6, 7, 8, or 9 of Annex V to that Regulation.

Several concerns have emerged about whether these provisions are feasible or whether they will simply prove to be insurmountable obstacles that will force companies to place fertilizing products on the market under National Rules where normal REACH requirements still apply.

The following negative impacts have been identified in the Position Paper issued by EBIC in 2023:

• The REACH registration cost could increase considerably the cost of the final fertilizing product.
• Increased administrative burden due to the number of REACH registrations to be assessed.
• Possible scenario of endangerment of substance supplies due to lack of profitability or unwillingness to share information.

In case you need further information about REACH+ and how this can affect your fertilizing product, please contact us at admin@kaeltia.com, we will be pleased to assist you.

Since today, we will be visiting and learning at the Parc Floral de Paris, at the 20th edition of the international pest control technologies show: Parasitec 2023.

As they explain in their website https://france.parasitec.org/en/index : “Research and formulation laboratories and manufacturers representing around 30 nationalities will be exhibiting throughout the 5,375 sqm venue at the 2023 show”.

Kaeltia’s representative, Elisa Capellan, will be discovering the latest innovations and having work meetings until tomorrow.

If you are interested in having a meeting with her, please feel free to call at +34 626 789 777 or send her an email at elisa.capellan@kaeltia.com

We hope you enjoy the show!

The 18th edition of Annual Biocontrol Industry Meeting (ABIM) is taking place this days  in Basel (24th, 25th and 26th of October) with more than 1800 delegates from more than 50 countries,  KAELTIA’s representative, Elisa Capella, is attending this premier global meeting for the biocontrol industry.

This annual meeting is internationally recognised as the platform for networking with professionals from all over the world, learn about the latest regulatory developments, discover and present new products and research and discuss market opportunities.

You can find more information of this event at: https://www.abim.ch/

If you want to contact Dr. Elisa Capellan, please feel free to call at +34 626 789 777 or send her an email at elisa.capellan@kaeltia.com

We hope you are enjoying the event!

Synergy between organisations sharing common goals often leads to significant advances in society. In this context, we are pleased to announce our collaboration with CABI BioProtection Portal, a step forward in our joint quest for a more environmentally friendly agriculture.

What is the CABI BioProtection Portal?

CABI’s BioProtection Portal is an open access tool that has revolutionised the way farmers and farm advisors deal with pests in their crops. Focused on providing information on biocontrol products and biopesticides registered in different countries, it aims to empower the farming community to identify, obtain and effectively apply natural solutions against pests. The platform, available in different formats and devices, is enriched with a comprehensive resources section for those who wish to learn more about bioprotection.

What is CABI?

CABI, an intergovernmental, non-profit organisation, is dedicated to improving lives around the world through the application of scientific knowledge to challenges in agriculture and the environment. Guided by the interests of the 49 member countries that influence its operations, CABI works with scientists in a global network of centres to provide information and practical solutions to all people. Founded under a United Nations treaty, the website is governed by equal cooperation among member countries in its governance and strategic orientation. Already active in 38 countries, it includes more than 4,000 biosecurity products covering more than 940 crops and 2,200 pests.

Why use the CABI BioProtection Portal?

In the last years, the biosecurity industry has made significant advances, bringing safer and more environmentally friendly alternatives for pest control in agriculture. However, lack of information remains a barrier to widespread adoption.

Under this situation is where the CABI BioProtection Portal comes into play, closing the gap between awareness and action by providing information and establishing direct connections between producers and bioprotection manufacturers.

Who is the CABI BioProtection Portal directed to?

The website has not only become a valuable tool for producers and agricultural advisors seeking low toxicity solutions, but also for those wishing to access higher value markets such as organic products. Government regulators, private sector decision-makers, and manufacturers of biocontrol products, also look at the CABI BioProtection Portal as a vital source of information and collaboration.

Kaeltia’s Contribution to BioProtection Revolution

Through our Regulatory Affairs services, at Kaeltia Consulting we play an important role in the expansion of the CABI BioProtection Portal. By encouraging the gradual reduction of the use of the more toxic and hazardous chemicals in agriculture, we work in harmony with the vision of a future with a more environmentally friendly agricultural. Our commitment to the promotion and development of products that are more environmentally friendly and focused on promoting human health reinforces the website mission, and the global cause for biosafety.

In short, the collaboration between CABI and Kaeltia is a step forward in the bioprotection and agricultural sustainability revolution.

As Ulli Kuhlmann, CABI’s executive director overseeing the portal’s development, has said: “Collaborating with regulatory experts who support a movement towards natural pest management helps further the spirit of our mission, while providing the expertise needed to make a productive change.”

Our CEO, Elisa Capellán, also expressed our enthusiasm for the collaboration: “At KAELTIA we are committed to the environment, to the viability of our business, and to a safe and sustainable food system for all. That is why we have decided to join the CABI BioProtection Portal, who share and promote these same core values“.

These words convey the essence of a partnership that transcends borders, and unites efforts in the cause of biosafety and agricultural sustainability.

Through the CABI BioProtection Portal, access to natural solutions for pests and diseases, backed by scientific expertise and international cooperation, is democratised. Kaeltia Consulting, with its focus on regulation and commitment to sustainability, contributes to the advancement of this important cause, paving the way towards a healthier and more planet-friendly agriculture.

Together, CABI and Kaeltia are driving innovation in agriculture and respect for nature.