Plant protection products: Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market requires that cumulative and synergistic effects must be taken into account. A guideline on the cumulative assessment of plant protection products was developed at the BfR, based on international discussions at the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA), and published in 2014. The procedure has been used at the BfR in authorisation procedures for plant protection products since 2017. Essentially, the aim is to cumulatively assess various active substances in a plant protection product or in an authorized tank mixture in a multi-stage procedure. To this end, both the exposure of users (such as farmers who apply the product in the field) and the acute exposure of consumers (who ingest the residues via food) are considered, so that the groups most exposed to these mixtures are taken into account. Since 1 September 2020, workers and uninvolved third parties (residents and bystanders) have also been included in these considerations.
From the BfR's point of view, there is already a large body of scientific knowledge on the effects of multiple residues of plant protection products. There is no reason to assume that the assessments currently carried out are not sufficiently conservative (i.e. they tend to overestimate the risk). Nevertheless, these testing and assessment strategies are constantly being developed and are the subject of research projects.
Biocidal products: Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products requires cumulative and synergistic effects to be taken into account in the health risk assessment. A procedure for assessing such effects is described in the European Chemicals Agency (ECHA) guidance document on the assessment of biocides and is applied in the authorisation procedure for biocidal products. The aim is to consider the active substances and toxicologically relevant co-formulants / contained in a biocidal product together in order to cover possible additive or synergistic effects. The procedure considers both short-term and long-term exposure and is used at the BfR for the assessment of non-professional users and uninvolved third parties. The assessment for occupational users is carried out by the Federal Institute for Occupational Safety and Health (BAuA).
Food contact materials: The Framework Regulation (EC) No. 1935/2004 regulates for all items and materials in contact with food that, when used as intended or in a foreseeable manner, they must not release substances into food in amounts that could endanger the health of consumers. This therefore also applies to mixtures of substances. In addition, in particular for plastic food contact materials (FCMs) European Regulation (EU) No. 10/2011 applies. It contains a list of substances that may be used in the manufacture of plastic FCMs and defines conditions of use and, where applicable, migration (i.e. release) limits (i.e. the maximum amount of a substance that may migrate into food). Before substances are included in this list, the European Food Safety Authority (EFSA) carries out a risk assessment. If data is available, this assessment also takes into account the toxicity of the mixture.
In its assessment of substances for inclusion into the BfR recommendations on food contact materials , the BfR also takes into account data on the mixture toxicity of substances - where available - and sets corresponding summation guide values for the tolerable transition into food or use of substances.
Cosmetic products: According to the definition in Cosmetics Regulation (EC) No. 1223/2009, cosmetic products are "substances or mixtures intended to come into external contact with parts of the human body (skin, hair system, nails, lips and external intimate regions) or with the teeth and mucous membranes of the oral cavity for the sole or vast purpose of cleansing, perfuming, altering the appearance, protecting, maintaining in good condition or correcting body odour."
Mixtures within the meaning of the Regulation are "mixtures or solutions consisting of two or more substances." According to Article 3 of the Regulation, cosmetic products made available on the market must be safe for human health under normal or reasonably foreseeable conditions of use. The regulation ensures this by requiring that the cosmetic product has undergone a safety assessment before being placed on the market and that a safety report for the cosmetic product has been drawn up in accordance with Annex I. The safety assessment must be carried out both for the individual ingredients and for the final product, so mixture toxicity is also taken into account in the safety assessment.
Plant protection products: Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market requires that cumulative and synergistic effects must be taken into account. A guideline on the cumulative assessment of plant protection products was developed at the BfR, based on international discussions at the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA), and published in 2014. The procedure has been used at the BfR in authorisation procedures for plant protection products since 2017. Essentially, the aim is to cumulatively assess various active substances in a plant protection product or in an authorized tank mixture in a multi-stage procedure. To this end, both the exposure of users (such as farmers who apply the product in the field) and the acute exposure of consumers (who ingest the residues via food) are considered, so that the groups most exposed to these mixtures are taken into account. Since 1 September 2020, workers and uninvolved third parties (residents and bystanders) have also been included in these considerations.
From the BfR's point of view, there is already a large body of scientific knowledge on the effects of multiple residues of plant protection products. There is no reason to assume that the assessments currently carried out are not sufficiently conservative (i.e. they tend to overestimate the risk). Nevertheless, these testing and assessment strategies are constantly being developed and are the subject of research projects.
Biocidal products: Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products requires cumulative and synergistic effects to be taken into account in the health risk assessment. A procedure for assessing such effects is described in the European Chemicals Agency (ECHA) guidance document on the assessment of biocides and is applied in the authorisation procedure for biocidal products. The aim is to consider the active substances and toxicologically relevant co-formulants / contained in a biocidal product together in order to cover possible additive or synergistic effects. The procedure considers both short-term and long-term exposure and is used at the BfR for the assessment of non-professional users and uninvolved third parties. The assessment for occupational users is carried out by the Federal Institute for Occupational Safety and Health (BAuA).
Food contact materials: The Framework Regulation (EC) No. 1935/2004 regulates for all items and materials in contact with food that, when used as intended or in a foreseeable manner, they must not release substances into food in amounts that could endanger the health of consumers. This therefore also applies to mixtures of substances. In addition, in particular for plastic food contact materials (FCMs) European Regulation (EU) No. 10/2011 applies. It contains a list of substances that may be used in the manufacture of plastic FCMs and defines conditions of use and, where applicable, migration (i.e. release) limits (i.e. the maximum amount of a substance that may migrate into food). Before substances are included in this list, the European Food Safety Authority (EFSA) carries out a risk assessment. If data is available, this assessment also takes into account the toxicity of the mixture.
In its assessment of substances for inclusion into the BfR recommendations on food contact materials , the BfR also takes into account data on the mixture toxicity of substances - where available - and sets corresponding summation guide values for the tolerable transition into food or use of substances.
Cosmetic products: According to the definition in Cosmetics Regulation (EC) No. 1223/2009, cosmetic products are "substances or mixtures intended to come into external contact with parts of the human body (skin, hair system, nails, lips and external intimate regions) or with the teeth and mucous membranes of the oral cavity for the sole or vast purpose of cleansing, perfuming, altering the appearance, protecting, maintaining in good condition or correcting body odour."
Mixtures within the meaning of the Regulation are "mixtures or solutions consisting of two or more substances." According to Article 3 of the Regulation, cosmetic products made available on the market must be safe for human health under normal or reasonably foreseeable conditions of use. The regulation ensures this by requiring that the cosmetic product has undergone a safety assessment before being placed on the market and that a safety report for the cosmetic product has been drawn up in accordance with Annex I. The safety assessment must be carried out both for the individual ingredients and for the final product, so mixture toxicity is also taken into account in the safety assessment.
