Science articles archivos - Kaeltia Consulting

REACH framework. Compliance in the Fertilizing Product Regulation

May 2, 2024 kaeltia

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.

Science articles

Pet Food Labeling in the USA. Summary of general labeling requirements

April 30, 2024 paneles

Pet food products and treats in the United States are regulated by the Food and Drug Administration (FDA), which governs the manufacture and sale of such products by requiring that pet foods, like human foods, be manufactured under safe and sanitary conditions, contain no harmful substances, and be clearly and truthfully labeled.

FDA relies on the American Association of Feed Control Officials (AAFCO) and other state regulators as a source of information on state regulations. AAFCO is a voluntary organization created by state, federal, and industry officials who have developed a set of “Model Regulations for Pet Foods and Specialty Pet Foods” found in official AAFCO publications. The Association is not a regulatory body, but regulatory agencies such as the FDA recognize AAFCO standards as guidance in the oversight of pet foods.

The pet food label is a very important communication element, which is regulated at both the federal and state level. The regulations address not only the labels affixed to the food but also any form of communication about any aspect of the product in various media.

The federal regulations are published in the Code of Federal Regulations (CFR), Title 21 CFR.

Requirements for pet food and treat labels are set forth within AAFCO, where general information that must appear on products is outlined through model legislation, which contains a checklist for labels.

The main regulations focus on labeling information and ingredients that can be used and there are also rules on descriptive and non-mandatory information. AAFCO has listed the 8 mandatory elements that a pet food label must contain:

Brand and product name: the way in which ingredients may be included in the product name and certain uses of descriptors are contemplated.
Name of the species for which the product is intended: the name of the species for which the product is intended must be visibly indicated.
Quantity declaration: the net weight or volume should be indicated in the lower third of the main display panel.
Guaranteed analysis: the nutrients provided by the food must be listed, supported by verifiable methods of analysis. Guarantees should be given in a specific order, in specific units and with a minimum or maximum depending on the case.
Declaration of ingredients: they must be listed in order of weight within the formulation, from the highest to the lowest.
Nutritional adequacy claim: this claim indicates that the food is complete for the life stage claimed. Certain products may be exempt from this claim.
Feeding instructions: products must include feeding instructions indicating the amount of feed by weight/species. Depending on the category of the product it may be necessary to provide additional information.
Name and address of manufacturer or distributor: the person or company responsible for the product and its location should be indicated. Where necessary, other companies manufacturing or distributing the product could be included.

In addition to these mandatory items, other declarations may be included following analytical methods and indicated according to specific formats.

Depending on the product packaging, if the label is placed only on the front side, all items must appear there. If the label is front and back, certain items must be mandatorily included on the main display side, on the front of the package.

Kaeltia Consulting provides specialized scientific and regulatory support to meet the regulatory compliance needs of pet food products in the USA, complying with the criteria established by the agencies and new regulatory frameworks. Kaeltia Consulting has more than 10 years of experience helping clients around the world to market their products under specific regulations.

For more information about our services, please contact us at info@kaeltia.com. We will be happy to assist you.

Science articles

BeCrop® Trials, your partner in innovation

April 25, 2024 kaeltia

Currently, international organizations, governmental institutions and private companies in the agricultural sector consider that soil health is key to produce food with better nutritional values and, therefore, healthier. The importance of knowing the health of the soil has led to the increasing use of techniques to obtain information on the microorganisms that inhabit it, with the aim of positively influencing its balance and function.
Improving soil health is very important for companies that produce inputs, which is why they have remodeled their product ranges, with the intention of achieving this objective The problem arises when there are several products on the market that claim to produce the same effect on the soil and crops, but do not have scientific validation, which causes the product to lose credibility in the market and there may be a possible deterioration of the company brand image
In order to avoid this situation and to strengthen links with their customers, companies that manufacture inputs must demonstrate the effects that their products are having on the soil in the medium and long term. In addition, knowing the effects is important for future product formulations or screening
There is a technology that solves these problems and is being used by many ag input companies across the globe. Its name is BeCrop® and it was developed by Biome Makers This technology is based on the scientific article “Network Properties of Local Fungal Communities Reveal the Anthropogenic Disturbance Consequences of Farming Practices in Vineyard Soils” which has been validated by the scientific community and published.
The technology is applied in 3 steps The first is soil sampling, this process is validated by Biome Makers and was developed to achieve the highest possible accuracy. The second step is DNA sequencing of soil microorganisms, this process is the most accurate worldwide due to the use of a database of more than 14 million taxonomic references. Finally, advanced bioinformatics and artificial intelligence technologies are applied, transforming the data obtained into a report that reflects information in 2 dimensions: biodiversity, i.e. the microbes that exist in the soil, and functionality, i.e. functions of these microorganisms and their impact on health and nutrient cycles
From this technology, BeCrop® Trials was created, which was developed to analyze all the effects that an input produces on the soil microbiome BeCrop® Trials is a very precise service due to the statistical complexity it uses, because it requires at least 2 locations, 3 replicates and 2 time periods.
Once the analysis is completed, a report is obtained with data on how the product affects, both positively and negatively, the plot analyzed. Companies also get access to the BeCrop® Portal platform, which is used to carry out more detailed analyses
In this project carried out with SeedForward, the effects of the Canola Guard product were tested by performing a BeCrop Trials You can read the real application case by clicking here and you can also watch the complete webinar on the case here. With all this information, problems associated with not knowing the effects of inputs can be avoided. This will help input production companies and their distributors to be able to have scientific reasons that they can provide to their customers to validate commercial claims on soil effects and improve the commercialization of the products.

Science articles

Improving soil quality for a sustainable food production

April 24, 2024 kaeltia

How to increase sustainable food production in a hotter and drier climate for a constantly growing population while soil is protected?

Throughout the past century, advancements in agricultural technology have allowed farmers to feed a human population in constant growth and this has contributed to a huge deterioration of soil health.

A frequently cited definition of soil health comes from Doran et al. (1996): ‘[soil health is] the continued capacity of soil to function as a vital living system, within ecosystem and land-use boundaries, to sustain biological productivity, maintain the quality of air and water environments, and promote plant, animal, and human health’. This definition represents an integration of biological, physical and chemical domains (Idowu et al., 2008), reflecting a recent emphasis on soil as a living system.

As stated by the USDA Natural Resources Conservation Services (NRCS) “Soil is not an inert growing medium – it is a living and life-giving natural resource. It is teaming with billions of bacteria, fungi, and other microbes that are the foundation of an elegant symbiotic ecosystem”. Soil health for a farmer is directly linked to plant yield but it has other advantages. Healthy soils produce more nutritious food and give plants greater resilience to pests and diseases. Healthy soils also hold more water, making this available to plants when rainfall is unreliable, or absorbing more during heavy rains, preventing floods and the run-off of vital nutrients from fields.

In most ecosystems, more life and diversity lives underground than above. Soil organisms such as bacteria, fungi, protozoa, nematodes, arthropods, and earthworms, play critical roles such as decomposition, mineralization, pollutants degradation, carbon and nitrogen cycling, amongst others. The rhizosphere is the location of much soil biological activity and plant-microbe interactions including symbioses, pathogenic infection, and competition. The types of species present and their level of activity depends on micro-environmental conditions including temperature, moisture, aeration, pH, pore size, and types of food sources.

Plant pest dynamics depend on the whole mix of organisms in the soil. Some organisms prey on or compete with disease-causing organisms. Some bacteria release plant growth factors that directly increase plant growth.

So, how we can increase the food production in a sustainable way for the humans and the environment while we protect the soil health?

Measuring soil quality: physical, chemical, and biological properties of the soil.
Minimize soil disturbance like tillage and return plant residues to the soil ? rebuilding the stock of soil organic matter, preventing loose soil particles, increasing biodiversity and bioactivity, protecting the network created by mycorrhizal fungi.
Reduce the use of unnecessary nutrient fertilizers by monitoring regularly the nutrients in soil before making applications.
When working with biologicals (living organisms) to control a pest, treat a disease or biostimulate plant physiology, the impact in the existing ecosystem should be analysed. The use of biologicals is different than working with chemicals where actions/effects can be more easily predicted. Interaction occurs in a very complex way, adding species can provoke the increase or decrease on existing species, beneficial or not, so unpredictable effects can occur. Partners in the soil change over the time and plants select each time the best microbiome when it is available, so this should be considered on a case-by-case basis to allow biologicals to success in the future.
When pesticides are needed, the use of less (eco)toxic substances are preferable to avoid impacts on the soil microbiome and the microbially-mediated processes that affect soil functioning.
We need urgently awareness of good agricultural practises, as soil health has the power to improve plant, human and animal health (“One Health” concept) so we can find together the best way to take advantage of this.

Science articles

Hazard Coformulants Assessment (Part 2)

April 22, 2024 kaeltia

ITEM 3_Strategy to identify combined effects and level of data

There is a non-exhaustive list of existing predictive tools that take into account potential interactions between substances as TEST, QSAR or BPR documents. The proposed solutions are to follow the guidance documents to assess combined exposure for ecotoxicology and toxicology. Also, the CLP calculation can be used to conduct additive assessment. It is proposed to collect data on synergistic effects by conducting a systematic literature search.

ITEM 4_Specific co-formulants

a)Co-formulants that are approved/no more approved/not approved as pesticide a.s.

If a co-formulant has a proven pesticidal activity in the PPP, it should be declared as a.s. And the composition of PPP should be reviewed by the physical chemical experts.

b)Co-formulants that are polymers in PPP

In principle, for human health, there is no concerns as currently they are exempt from REACH registration. For environment, there is concerns due to the accumulation of plastic in nature. However, due to the current concerns as stability, toxicologically relevant residual monomers, lack of data on toxicity, information on identity, assessment of alternatives so several solutions have been proposed. For example, acceptable PPP storage stability data to indicate the stability of polymer co-formulants and specifications of the co-formulant should be requested to demonstrate the concentration and identity of unreacted monomers present in the polymer co-formulant.

c)Co-formulants that are UVCBs

Due to the exact composition is often unknown, it is difficult to generalize their risk profiles or establish standard test protocols for their evaluation. The proposed solutions are to use the ECHA definition and request the performance and composition specification.

d)Co-formulants that are PFAS

There is a PFAS restriction proposals and a list of PFAS also identified as active substances. The proposed solutions are to use the OECD and ECHA definition and if there is a co-formulant meeting the PFAS definition, to consider for the risk assessment for mammalian toxicity and ecotoxicity.

e)Co-formulants that are formaldehyde releasers

Formaldehyde cannot be used as a co-formulant with exceedance of 0.1% as an impurity in

a PPP. However, there are intentional and unintentional release of formaldehyde as impurities from co-formulants used in PPP. There is a list of formaldehyde releasers that can be checked and should be considered for risk assessment (mammalian toxicity and ecotoxicity).

Science articles

Mycorrhizas Invisible but essential for the agriculture

April 17, 2024 kaeltia

Mycorrhizas
Invisible but essential for the agriculture

It is difficult to estimate when the first plants appeared on our planet Earth. We can imagine that approximately 600 million years ago, seaweed decided to colonize what at that time was a dry soil like the lunar surface. Since then, the first ferns emerged, adapted to the environment and began to establish symbiotic relationships with the fungi that lived in their root system. This relationship materialized in the formation of “supra-organisms” where the fungi obtained carbohydrates from the ferns and these, in return, received water resources, dissolved salts and other biostimulants, allowing both to grow in a mutualistic relationship (symbiosis), where the long-term relationship that they maintain benefited both parties. This community of fungi is known as mycorrhizae. Therefore, there is no doubt that mycorrhizae can be considered an agroecological strategy to optimize crop quality.

We can ask ourselves why our crops are increasingly sensitive to pests and diseases or why they have less quality, among other unwanted characteristics. The problem is that the value of the soil resource and the biomass that lives in it is neither perceived nor valued. In the last decades of exploitation of our crops, there was no awareness of the degradation of the soil, of its properties, including the loss of the mycorrhizal community that colonized the roots of the plants that grew in them. The loss of vegetation cover and increased erosion are signs that this “supra-organism” no longer inhabits those soils.

During the last century, agricultural production focused mainly on the use of mineral fertilizers and chemical products which, to maintain crop yields, involved the use of massive doses that have led us today to the state of degradation that we suffer in the soil. Fortunately, research in recent years in agricultural inputs has been aimed at biological components, such as pests and diseases’ Biocontrol products and Plant Biostimulation, which contribute to increasing soil fertility, as well as improving soil stability and functioning of the entire ecosystem.

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Science articles

Development of Resistance to phytosanitary products in the EU. How to address it efficiently?

April 15, 2024 kaeltia

Three of the most determining factors in the use increase of phytosanitary products (PPP) in recent decades have been, on one hand, the soil degradation, its physical and chemical properties as well as the destruction of the biomass (macro and microscopic) that stabilized it. On the other hand, there would be the deterioration of the innate immunity system that plants had to defend themselves from both, biotic and abiotic factors. And as a third factor, no less important, would be the introduction of new pests and diseases from third countries due to poor control by our administrations, which either legislate in a very lax way and/or do not carry out sufficient controls. It is estimated that an average of 10 new harmful organisms are detected every day in the EU territory and the forecast for the coming years is a considerable increase in these events.
There is no doubt that the development of phytosanitary products with specific methods of action against pests and diseases represented a radical change in crop protection, due to their greater effectiveness (shock effect) with small doses. This practice led to the appearance of the phenomenon of resistance, that is, the ability of the pest or disease to survive the doses applied that were previously lethal for its species.
The development of resistance does not occur equally for all classes of chemicals; among the risk factors associated with PPP is the chemical family to which the active substance belongs and its mode of action. In recent years, the number of authorized phytosanitary chemical groups has suffered a great decrease, making it impossible to rotate treatments with different modes of action to avoid resistance.
In order to deal with the resistance to PPP in Europe, an EPPO Database on Resistance Cases was created. 26 EPPO countries are participating, and 17 countries entered resistance cases in the database. As of 2024-02-13, a total of 905 cases have been entered and only the resistance cases that have been validated by the EPPO Expert Working Group (EWG) on Resistance to PPP are published in the database and are visible to the public. Since the last EWG meeting in Athens, in September 2023, 255 new cases have been published.
This database was developed initially as a tool for the EPPO Expert Working Group on Resistance and has evolved into a platform to assist EPPO member countries and applicants involved in PPP authorization process. Since the creation of the database a total of 811 cases have been validated. This includes 421 fungicides cases (52%), 196 herbicide cases (24%), 155 insecticide cases (19%) and 39 acaricide cases (5%) have been published. The highest percentage (32%) of cases validated since the creation of the database come from France.

In addition to EPPO, there are two relevant working groups in Europe, such as FRAC which focuses on fungicide and bactericidal resistance prevention strategies and IRAC which focuses on the prevention of resistance to insecticides, acaricides and nematicides.

Among all the techniques available to avoid the appearance of resistance, in addition to all the specific recommendations by FRAC, IRAC as well as the approved instructions for use, the Integrated Pest Management (IPM) must be considered. IPM is the most efficient and environmentally friendly tool for the global protection of crops. IPM constitutes a dynamic process that uses an approach based on ecological systems whose objective is to maintain ecosystem functions and to this end, as a first step, the use of preventive practices in crops is recommended (soil health care, innate immunity of the plant (native species), resistant varieties, crop rotation,…). Next, and in a precise way, the soil and the plant scan be supplied with the fertilizers and biostimulants that best suit the crop, the soil and the rest of the ecosystem.

If pests and/or diseases appear despite these efforts, the use of biocontrol products is recommended in the first instance, with living control organisms, plant extracts, microorganisms-based products, semiochemicals, RNA-based products, among other options. Finally, if control requires the application of a chemical medicine, conventional PPP would be used.

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