European council adopts new rules on medical devices
On the 7th March 2017, the European Council adopted new EU rules to improve the safety of medical devices: benefitting patients whilst preserving access to innovative healthcare solutions.
HCWH Europe expressed major concerns about the Medical Devices Regulation, believing that it should address the presence of Carcinogenic, Mutagenic, and Reprotoxic substances (CMRs) and Endocrine Disrupting Chemicals (EDCs) contained in medical devices.
Annex I.2.7.4, of the Medical Devices Regulation includes a 0.1% concentration limit for category 1A and 1B CMRs and EDCs in devices that are invasive and come into direct contact with the body. This includes devices that: (re)administer, transport, or store medicines, body liquids, and other substances (including gases), to or from the body. Devices would only be permitted to contain such substances at a level above this limit if a justification is provided.
Importantly, within a year of the Regulation’s entry into force, the European Commission will provide a mandate for the relevant scientific committee to prepare guidelines on phthalates. This would include a risk-benefit assessment of their presence, (as they are known CMRs or EDCs) – such assessments would have to be updated within five years. The Commission would also issue similar mandates for the preparation of guidelines on other CMRs.
Annex II of the Regulations also includes labelling provisions: both a label on the device and the packaging would have to state if the device(s), and their parts or materials contain CMRs or EDCs above the concentration limit; a list of such substances must be included.
The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal. These new rules will apply to medical devices and vitro diagnostic medical devices three and five years after the regulations are published respectively.
The new EU regulation:
This new Medical Devices Regulation provides a stronger mandate to independent notified bodies in their assessment of medical devices before they can be placed on the market, and strengthens the oversight of these bodies by national authorities.
These new rules also ensure that notified bodies meet the same high safety standards throughout the EU.
These measures will both improve the safety of medical devices and improve the availability of clinical data on devices, as well as clearly set out manufacturers' responsibilities for the follow-up of the quality, performance, and safety of devices on the market.
Sometimes whilst eating, I feel as though I am sitting in a broken chair with only three legs; the problem is not the chair however, but the food in front of me.
In recent years I have seen numerous food movements evolve and converge with others, working for better access to health, environmental justice, and gender, racial, and economic equity. Food is the entry point for the majority of problems in today’s society; it can help us work towards a healthier and more sustainable future. Food can address the multitude of social, environmental, economic, and health challenges we face, whilst simultaneously supporting community development. We need to understand the links between these issues and food, as shown by the 2016 Food Sustainability Index (FSI).*
Nutrition label standards and regulations on the use of claims and implied claims on food
Offer healthy food and set standards in public institutions and other specific settings
Use economic tools to address food affordability & purchase incentives
Restrict food advertising and other forms of commercial promotion
Improve nutritional quality of the whole food supply
Set incentives and rules to create a healthy retail and food service environment
Harness food supply chain & actions across sectors to ensure coherence with health
Inform people about food & nutrition through public awareness
Nutrition advice and counselling in health care settings
Give nutrition education and skills
This framework will help to reduce obesity and other non-communicable diseases (NCDs) for different populations, and provide an extensive and innovative overview of implemented government policy actions from around the world.
These ten areas encompass food environments, food systems, and behaviour changes in communication; influencing the “who”, “what”, and “where” aspects of the food we eat.
This holistic view, the resulting strong evidence, and practical experiences contribute to the rethinking of our food and the systems that produce it...
The European Parliament (EP) today voted in plenary session on the EP’s report and amendments to the European Commission’s (EC) proposal - COM(215) 595 final - to revise the Waste Framework Directive (2008/98/EC).
HCWH Europe welcomes the EP’s support of the amendments on food waste - such as a new food waste definition, a food waste hierarchy, and food waste reduction targets.
No common definition of “food waste” currently exists in the EU, which forces Member States to work with different national definitions and, as a consequence, different methodologies to prevent and reduce food waste. Today, the EP recognised the need for a harmonised, legally binding, European definition of food waste in order to better regulate food waste and improve prevention and reduction efforts across all Member States.
The new EP food waste definition includes: “food intended for human consumption, either in edible or inedible status, removed from the production or supply chain to be discarded - including at primary production, processing, manufacturing, transportation, storage, retail, and consumer levels, with the exception of primary production losses”.
HCWH Europe welcomes the important addition of a definition of food waste, but regrets the exclusion of losses at the primary production stage from it. By excluding this stage, a considerable amount of food waste will not fall under this definition, and therefore there will be no obligation on Member States to reduce it.
HCWH Europe also applauds the adoption of a food waste hierarchy - this is a key instrument that will play a major role in food waste management, as food has specific priorities and potential for re-use that are not applicable to waste management of other products. For example, there are particular recovery processes that can only be applied to food, such as the donation of unused food to charities and social organisations, for animal feed, or composting. Now approved by the EP, these resourceful stages of food waste management are one step closer to being officially recognised by the EU and becoming legally binding for Member States.
“The European Parliament has voted in favour of many important amendments to improve the management of food waste. We feel particularly optimistic about the inclusion of a review clause calling on the European Commission to set legally binding targets by 2020. This demonstrates that the European Parliament is determined to move towards reducing food waste. We hope that Member States will back this call, and that the EC will follow through and set the legislative targets that are badly needed to drastically reduce the senseless wastage of food across the Union.”
Ana-Christina Gaeta, Resources Policy Officer - HCWH Europe
Today’s vote was in favour of Member States working towards the objective of a 30% reduction in food waste by 2025, and a 50% reduction by 2030. As welcome as these reduction targets are, the wording of the targets means that they are not legally binding and therefore will not guarantee that Member States will actually meet the targets...
A federation of care institutions in Flanders, the northern part of Belgium. The members of Zorgnet-Icuro include all Flemish general and university hospitals, mental care institutions, and elderly care homes. It provides its members with a collective voice and with the context for collaboration (amongst its members and with stakeholders e.g. governments). In collaboration with the Flemish government, Zorgnet-Icuro has committed itself to a significant yearly reduction in CO2-emission. We have joined HCWH to share our experiences with likeminded organisations and to exchange insights with them.
The national hospital of Iceland serves the majority of the country, with 700 beds and 5,000 employees. The Landspitali hospital offers diverse clinical services in outpatient clinics, day patient units, inpatient wards, critical care units, clinical laboratories, and other divisions. In 2012, Landspitali signed an environmental policy with focus on reducing waste and disposables, green procurement, enhancing sustainable transportation, minimising negative effects of chemicals and medicines, clean energy and water, information and training on environmental issues, as well as BREEAM for new constructions. Landspitali have been rewarded several times for its environmental work. It is important for an organisation like Landspitali to learn from others and share experiences; HCWH Europe is a perfect choice for us.
A non-profit organisation dedicated to helping people suffering from environmental diseases. Our clinic, an outpatient hospital near Madrid (Spain), is an Environmental Control Unit, free of toxic chemicals and electromagnetic pollution. Patients receive therapy under special conditions, identifying of the source of their sensitivities - food, inhalants, etc. This is essential when speaking about diseases like Chemical Sensitivity, Fibromyalgia, Chronic Fatigue, Autism, Obesity, Food allergies, and others. Fundación Alborada gives training to health professionals through cooperation agreements with the Complutense University of Madrid, the College of Physicians of Madrid, and the American Academy of Environmental Medicine. We organise an International Congress on Environmental Medicine every two years and develop raising awareness campaigns at national and international levels to prevent exposure to toxic chemicals in food, cleaners, toys, medical materials, and others. We have joined Health Care Without Harm Europe in order to know more organisations sharing our view and to work together for a healthier environment in the places where it is most needed: hospitals and healthcare centres where patients should recover from diseases.