Safety Regulations of Food Enzymes

Većina dostupnih industrijskih enzima primjenjuje se u prehrambenoj industriji. Zakonska regulacija njihove primjene razlikuje se od zemlje do zemlje, počevši od potrebne dozvole prije izlaska na tržište pa sve do informacija koje proizvodači trebaju dati za procjenu sigurnosti. Najveća su opasnost za sigurnost radnika alergenska svojstva enzima, jer je utvrđeno da su oni mogući inhalacijski alergeni te da mogu uzrokovati alergijsku reakciju poput astme. U izolatima enzima mogu biti i toksične tvari, uključujući bakterijske toksine i mikotoksine opasne za zdravlje potrošača. Postupci provjere sigurnosti su izgleda prikladni, jer dosad nije zabilježen niti jedan incident, zbog čega je predložen reducirani postupak provjere. Također su smanjene mjere opreza i praćenja sigurnosti primjene enzima u industriji, ali to ne znači da su sasvim uklonjeni profesionalni rizici. Izazov predstavljaju neriješena pitanja poput onih može li izravni dodir s enzimima uzrokovati alergijsku reakciju te nedostatak usklađivanja zakona s procjenom sigurnosti. U Europskoj uniji primjena većine enzima nije zakonski regulirana niti na razini Unije niti u pojedinoj zemlji clanici pa se postavlja pitanje sigurnosti primjene dostupnih enzima s novim i neobičnim svojstvima. U budućnosti ce biti potrebno u Europskoj uniji uskladiti zakone za reguliranje primjene enzima u proizvodnji hrane.The majority of industrial enzymes available at present is used in food industry. Safety regulations of food enzymes differ among countries, including fundamental aspects, whether a pre-market approval is needed and on the level of details, e.g. what particular information manufacturers have to provide in the course of safety evaluation. Occupational safety concerns focus on allergenic properties as it is well established that enzymes are potent inhalative sensitizers and can cause allergic reactions including asthma. Otherwise toxic substances including bacterial toxins and mycotoxins might also be present in enzyme isolates and might thus constitute a safety risk to consumers. Safety evaluation procedures seem to be appropriate as no incidents have been reported so far, resulting in suggestion for reduced test packages. Safety precaution and monitoring measures established by industry have also reduced but not entirely eradicated occupational risks. Challenges to regulators and industry arise from unresolved issues, e.g. whether enzymes might be contact sensitizers, and from the lack of harmonisation of both legislation and safety evaluation. In the EU, most food enzymes are not covered by food safety regulations neither on Community nor on national level. On top of this the availability of enzymes with new and unusual properties raises questions of safety. In the EU there seems to be a chance that these challenges will be tackled in the course of establishing a harmonised legislation on food enzymes

Was wir vom Umgang mit Bio- und Nanotechnologien lernen können

Der Umgang mit Bio- und Nanotechnologien hat gezeigt, dass die Risiken in der Öffentlichkeit in der Regel nicht realistisch eingeschätzt werden. Begleitende Forschung zur Einführung von konvergierenden Technologien muss daher einen gesellschaftsorientierten Ansatz verfolgen

Editorial : Plant Genome Editing – Policies and Governance

[No abstract available

Structured analysis of broader GMO impacts inspired by technology assessment to inform policy decisions.

If genetically modified organisms (GMOs) are approved in the EU for experimental release or marketing authorization (placing on the market), a risk assessment (RA) is carried out beforehand to determine whether this may be associated with negative effects on human health, nature or the environment. Applications are reviewed by the European Food Safety Authority (EFSA) and the national Competent Authorities of the Member States. However, the potential ramifications of the GMOs that are systematically addressed in the current RA context are limited. Broader consideration can include environmental and health aspects beyond the scope of the statutory RA, as well as societal, ethical and cultural impacts. These other levels of impact may be considered during the comitology process of authorisation, but how this is done is typically not made explicit in a systematic way. However, with the dynamic developments of new kinds of GMOs, these considerations as well as transparency regarding the role of broader considerations in political decision-making become more and more relevant. Against this backdrop, we identified the requirements and suggest the main elements for such a broader assessment. We use insights from the field of Technology Assessment (TA) to explore the requirements for operationalising a rapid but still systematic, transparent and broad case-by-case GMO assessment compatible with the existing legislative framework.publishedVersio

From Farming to “Pharming”. Risks and Policy Challenges of Third Generation GM Crops

Commercial and academic activities in the production of pharmaceuticals or other substances of industrial interests from genetically modified plants, i.e. molecular farming, have so far centred in the USA and Canada. Recent increases in EU activities and the proximity to market stage of the first plant-made pharmaceuticals, some of which from EU based companies, represent a call to action for EU regulators. Drawing on the North American debate on molecular farming it will be argued that both the rationale of and the risk issues associated with molecular farming will differ significantly from those of first generation GM crops. Based on these differences, the suitability of the existing regulatory framework, which essentially was developed in response to the arrival of insecticide and herbicide tolerant crops for food and feed use, is discussed. Possible options for adapting the already complex EU regulatory system to cater for molecular farming are examined. It will be argued that the policy challenges posed will inevitably spark a broader public debate. As an issue for debate, molecular farming is located at two crossroads: of the risk debate on agricultural biotechnology and the sustainability debate on renewables and greening of industry and of red and green biotechnology. Complex scientific, technical and legal issues, new issues at stake and a new pattern of actors are likely to give EU regulators a difficult time

Risk-assessment policies: Differences across jurisdictions

This study examined how risk assessment policies are in practice being decided and operationalised at Codex and in five countries: the USA, the UK, Germany, Japan and Argentina. Our starting assumption was that, where public policy-making institutions formally take responsibility for risk appraisal and decision-making, some risk assessment policy assumptions arise, even if they are not explicitly acknowledged or labelled in those terms. We found that the choice was not between having a risk assessment policy and not having one, but between being explicit and transparent about RAP judgements, or being implicit and opaque

Inclusive development and prioritization of review questions in a highly controversial field of regulatory science

Abstract How to best assess potential health, environmental and other impacts of genetically modified organisms (GMOs) and how to interpret the resulting evidence base have been long-standing controversial issues in the EU. As a response, transparency and inclusiveness became a major focus of regulatory science activities in the GMO impact area. Nevertheless, nearly three decades of controversies resulted in a heavily polarized policy environment, calling for further efforts. Against this backdrop the EU funded project GRACE explored the value of evidence synthesis approaches for GMO impact assessment and developed an evidence synthesis framework with a strong emphasis on openness, stakeholder engagement, transparency, and responsiveness to tackle regulatory science challenges. This framework was tested and implemented in the course of 14 systematic reviews or maps conducted on selected review questions spanning potential health, environmental, and socioeconomic impacts of GMOs. An inclusive development and prioritisation of review questions is of key importance in evidence synthesis as it helps to provide a better link between stakeholder demands and concerns and policy relevant outcomes. This paper, therefore, places a particular focus on the stakeholder involvement strategy developed and experiences gathered during this particular step in the course of the GRACE project. Based on this experience, possible lessons for future engagement exercises in highly controversial fields of regulatory science are discussed