EU Regulatory Bulletin contents - October 2014
- EU Commission publishes BPR review programme Regulation
- ECHA issues official Article 95 list of relevant substances, and respective substance and product suppliers
- ECHA publishes a Practical Guide on the Biocidal Products Regulation
- EFSA issues Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for pesticides
- EU Health Commissioner-designate devoted to final EDC criteria
- REACH Directors’ Contact Group provides recommendations on data costs
On 23 October 2014, the European Food Safety Authority (EFSA) published new Guidance document which for the first time harmonizes the method for calculating the exposure to plant protection products (PPPs) for four major social groups – operators, workers, residents and bystanders.
By way of a background, Regulation (EC) 1107/2009 ensures that pesticides residues, consequent to the application of pesticides and in line with good plant protection practices, are not harmful to human health and the environment. To that end, in 2010 the EFSA Panel on Plant Protection Products and their Residues (PPPR) prepared a Scientific Opinion on pesticides exposure of the said groups, followed by further developments and a public consultation from this year. The Scientific Opinion identified inconsistencies between the approach of the regulatory authorities in the different Member States. It is in this context that the current Guidelines have been prepared by the EFSA experts.
The methodology set by the document is designed to assist industry applicants and risk assessors in the evaluation of risks for people when they are in contact with pesticides either as a part of their job or through other physical proximity (e.g. living areas close to fields where pesticides are used). In particular, the Guidelines evaluate the non-dietary exposure to these chemicals – mainly by absorption through the skin and inhalation, as well as possible hand-to-mouth transfer.
The characteristics of the four population groups covered by the Exposure Guidelines can be summarized as follows:
- Operators – professional farmers who carry out activities connected with the application of pesticides – i.e. mixing and loading of pesticides into agriculture machineries, in addition to cleaning, emptying or repairing such equipment.
- Workers – a person, who as a part of his/her job, either works with crops treated with pesticides, or enters an area previously treated with the chemicals.
- Residents – people living, working or attending a school close to areas where PPPs are used, and who do not wear special equipment preventing them from exposure.
- Bystanders – people who might be nearby an area treated with pesticides and again with no protective measures.
According to the EFSA, most of the exposure scenarios for the four groups fall into a category of a standardized first tier risk assessment to be applied as recommended in the guidance document. For those situations, which fall outside the proposed methods, risk assessor should follow reliable and realistic ad hoc approaches. Clearly, and as authority acknowledges, there are still some uncertainties in the document (e.g. lack of data for assessment of residents exposure); thus research institutes and scientists from Member States are welcomed to contribute to an ongoing review of the Guidelines.
The Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products can be found here.
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