In recent times, there is an important interest in hazard coformulants assessment together with the active substances due to the impact in the safe use of the PPP. EFSA and European Commission staff have developed several proposed solutions to address and support transparency and identification, data, and hazard assessment. In this Part 1, two of the four items discussed will be commented on. The next two points will be discussed in a later post:

ITEM 1_Information about the identification concentration and function of the co-formulants.

The first issue to solve is how to fully identify the co-formulants. Data requirements as defined in Regulation (EU) No 284/2013, full composition of co-formulants mixture up to 100%, information on impurities contained and other physical chemical data are requested.

Follow-up actions as a checklist of data have been proposed to fully identity co-formulants and a list of working definitions (glossary) for the assessment of PPP and co-formulants. These actions could be inserted in the Guidance document on significant and non-significant changes to co-formulants (under revision). If this is not possible, a guidance document could be drafted specifically for the chemistry aspects of the formulation and co-formulants. Another proposal is to have separate document for each co-formulant rather than a document, dRR for the plant protection product (PPP).

The second issue is how to access the confidential data of compositions. A short-term solution is to be shared among Member States (MSs) in a dedicated platform or from the suppliers directly in contact with MSs. A long-term solution is the creation of an EU common database.

The third issue is to define relevant co-formulant and co-formulant of concern to be taken into account for the risk assessment and monitor them during the stability study. The new CLP hazard classes could be taken into account. In this sense, there is a proposal of drafting of a guidance document with the inclusion of a list of non-exhaustive criteria.

ITEM 2_Hazard evaluation of PPP/Co-formulants

In principle, the following data should be available to assess the hazard effects:

  • Genotoxicity: screening of co-formulants to be performed as described in the Guidance document on the relevance of metabolites in groundwater metabolites, 2003.
  • Acute toxicity (ecotoxicity): For PPP, acute data (non-vertebrate species) are available in most of the cases pending on exposure. There is a lack of data for aquatics when the application does not lead to direct contamination of surface water. The following tiered approach is proposed: 1) to check the physical chemical properties and the environmental fate and behaviour data of the PPP/co-formulants and 2) to compare the toxicity of the PPP versus the active substance. If the PPP is more toxic, it would be due to toxicity of the co-formulants (or synergistic effect). In the case of higher toxicity, an exposure assessment is needed in order for the risk to be assessed. For co-formulants, the proposed tiered approach as proposed for the mammalian toxicity section could be used. The exposure should be considered before requesting long term toxicity data.
  • Acute toxicity (mammalian toxicity): For the majority of PPP, acute toxicity is addressed. Although depending on the “age” of the products, the data are available or not. For co-formulants, acute data are available in most of the cases from SDS or other legal framework than pesticide. Currently, the approaches taken by the MSs differ greatly so dedicated discussion to be organized with experts will be necessary in this point.
  • Long-term toxicity (mammalian toxicity): only co-formulants for which all data sets are available (including long-term toxicity) would be acceptable, unless the applicant wishes to generate data. Co-formulants which are considered not to be of concern and/or where some data are not necessary can be included in a positive list (based on the endpoint) or perform a tiered approach to screen critical co-formulants, those with data or not.

Waiving data can be considered valid with a case-case justification and based on expert judgement.

Different sources can be used for hazard identification and data to be considered: ECHA, EMA, EFSA, EU Commission (cosmetic ingredients, annex III), non-EU agencies. The applicant can use these sources explaining why the extracted information is relevant to the risk assessment.

How to share and harmonise information and evaluation of co-formulants is another important topic. There are existing databases at MSs level based on the EU survey (November 2022-January 2023) collecting the composition of co-formulants, ECHA biocide database on co-formulants and non-EU databases (e.g., US EPA). As long-term solution, it is proposed to create an EU harmonised database available to MSs, the EC and EU agencies with public and confidential versions. As interim solution, it is proposed to share existing databases among MSs on CIRCABC / DMS, feasibility to be checked by the EC and EFSA.

On the other hand, bridging assessment of PPP, alternative co-formulants and equivalence assessment have been evaluated. The proposed solutions for PPP are to draft a guidance document to better defined criteria (comparison of toxicity data and formulation type, composition and physical chemical properties, dermal absorption values, etc). The proposed solutions for co-formulants are to use the CLP approach by applying the read across approach. In the ecotoxicity and mammalian toxicity, bridging of co-formulant data may be needed in the case there is no direct exposure to the PPP and drafting a guidance document has been proposed.

There is a growing expansion of greener products in the cosmetics industry due to new consumer demands, being a very attractive segment for many companies wishing to have differentiating ingredients and products.

A few years ago, the focus was only on formulations, now the approach is holistic, including packaging, environmental commitments, ethics, social responsibility among other aspects, resulting in more sustainable cosmetic products.

Currently, there is no regulation or standard that indicates when a cosmetic product is considered “natural” or “organic”, unlike food products that have an EU Regulation that specifies the requirements and criteria to be considered within the organic production.

In the absence of regulations on natural and/or organic products, several companies in the sector have joined forces to create certifications for the various cosmetic products and thus establish parameters for evaluation and control. Among the main certifying bodies in Europe are Ecocert and Cosmebio in France, BDIH and Natrue in Germany, Demeter and Soil Association in the United Kingdom. Therefore, in order to obtain some of the organic or natural cosmetics seals, companies must voluntarily undergo certain evaluations and procedures before the certifying companies.

Among the main certifications we can find in the market is “COSMOS”, which has been developed by ECOCERT. On average, products certified by this standard contain 99% ingredients of natural origin, the other ingredients could be from a restrictive list of approved ingredients that are authorized in small proportions. Two classifications can be identified within this standard, first the “COSMOS NATURAL”, which must comply with a minimum of 95 % natural ingredients and the second “COSMOS ORGANIC”, with 95 % organic ingredients and 20 % of the total product which must be organic in order to comply.

Another certification seal that can be found in the international cosmetics market is NATRUE, which establishes a set of strict and transparent requirements for natural and organic cosmetic products. In order for a product to obtain this seal, at least 75% of the products of its brand or sub-brand must obtain certification to be able to use the seal. NATRUE is categorized into two types of products, natural cosmetics and organic cosmetics, for the latter at least 95% of the ingredients must be organic.

In Spain, there is a certification called BioVidaSana, promoted by the Vida Sana Association and bio.inspecta, under the control of Biocertificacion S.L., designed for small companies and traditional manufacturers. This standard has 3 different categories, depending on the percentage of organic or natural ingredients in the product.

There are also other leading organizations in the European Union that are in charge of evaluating greener cosmetics, among them the AIAB, CCPB, ICEA (Italy), ECO Garantie, Bioforum (Belgium) and CosmeBio (France).

Most standards and associations are based on similar fundamentals such as:

  • Include in products ingredients that are less harmful to human health, animal health and the environment.
  • To be transparent in the market, providing truthfulness in the information transmitted to consumers.
  • Increase in the percentage of organic ingredients and harmonization of lists of prohibited ingredients derived from petrochemicals.
  • Pursuit of social responsibility by promoting sustainable development and animal welfare.
  • Adequate waste management.
  • Packaging, labels, commercial material in smaller quantities and with better quality, minimizing unnecessary waste and maximizing the amount that can be recycled.

From Kaeltia Consulting, we advise national and international companies in obtaining greener certifications for cosmetic products, providing support at all stages of the process.

For more information about our services in cosmetics:

Cosméticos

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.

The biocidal active substances with anticoagulant rodenticide action (TP14) such as brodifacoum, bromadiolone, chlorophacinone, coumatetralil, difenacum, difethialone and floucoumafen are currently under the renewal process after submitting the corresponding applications to ECHA. The competent authorities of Denmark, Spain, Finland, France, Norway and the Netherlands evaluate applications as evaluating competent authorities.
Since, given the renewal evaluation times, it is likely that the approvals would expire (June 30, 2024) before decisions on their renewals have been made, it is appropriate to delay the expiration date of the approvals long enough to allow applications can be examined. Therefore, on 27 February 2024, the European Commission published Commission Implementing Decision (EU) 2024/734, delaying the expiry date of the approval of all these active substances (a.s.) until 31 December 2026.
Already in October 2023, ECHA informed the Commission that the evaluating competent authorities intend to submit their evaluation reports and conclusions of their evaluations to ECHA in the third quarter of 2024, when an idea of the preliminary conclusions might be available, and we will report on this in due course.
In accordance with the BPR, the approval of these a.s. can only be renewed if they continue to meet the conditions set out in the BPR Regulation as well as the derogating conditions. In this evaluation, the exclusion criteria currently established according to the BPR Regulation for each of these companies must be taken into account:

The European Union regulatory framework requires a thorough evaluation to ensure that biocidal products containing these s.a. do not present unacceptable risks to humans or the environment, balancing the benefits of rodent control with potential safety concerns. So, these a.s. are subject to rigorous scrutiny to confirm their safety and environmental compatibility. Therefore, the delay until the end of 2026 allows all parties involved (ECHA, Member States and Stakeholders) enough time to evaluate these substances.

For more information about our services in biocides CLIC HERE or contact us at info@kaeltia.com

We will be pleased to assist you!

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

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!