New supplement laws proposed to boost innovation and sector growth

By Nikki Hancocks contact

- Last updated on GMT

Getty | Marian Vejcik
Getty | Marian Vejcik

Related tags: Regulation, legislation, science, botanicals

The European Federation of Associations of Health Product Manufacturers (EHPM) has created a manifesto and regulatory proposal detailing significant legislative changes needed in order for the food supplements sector to reach its full potential to aid in healthy ageing and disease prevention.

The European food supplements sector has experience growth of over 6% (CAGR) since 2014, reaching €11.6bn in 2018 (Monitor Deloitte 2019) yet the sector is lagging behind its full potential due to restrictive and unharmonised legislation, according to EHPM.

The federation, which represents around 1600 health product manufacturers in 13 European countries, hosted a panel discussion at the European Parliament in Brussels this week (February 18th​) entitled “Food supplements for Healthier Citizens and a stronger economy in the EU” in which they revealed their manifesto for the sector.

The document describes the sector and gives a detailed explanation about what supplements are and what their role could potentially be if regulation is improved – not only supplementing the diet but playing a role in aiding people to age healthily and reducing the risk factors of disease.

MEP Pascal Arimont opened the discussion by saying that a predictable and well-harmonised regulatory framework is essential in order to encourage SMEs to further innovate.

“The regulatory frame work as it stands is not clear or well harmonised enough  to provide a level playing field for supplement producers across Europe.

“We need a legislative environment which promotes innovation and economic growth and supports economic growth and facilitates access to cross border trade.

Livia Menichetti, EHPM’s director general, added: "The food supplements sector is an incredible and legitimate sector that deserves a fair and legitimate framework to aid innovation, growth and create employment.

“Our products are often surrounded with misconceptions due to fake news and misleading information in the media and in the general public," ​she said.

“Food supplements can play an important role in supporting the public health system by helping citizens to stay healthier for longer and helping them to face health issues later in life.

“We welcome the Farm to Fork strategy which brings attention to transparency across the entire supply chain allowing consumers to know what they are consuming, where it has come from and its impact on the environment. We want to be proactively involved in that initiative.

“The key words for us are ‘safety’ and ‘quality’. We want to strengthen the way companies can control the products they put on the market by allowing them to track the ingredients in case any concern arises around their products they can proactively provide data to show we have control on what we put on the market.”

REFIT of EU legislation on nutrition and health claims

The Nutrition and Health Claims Regulation (NHCR) is supposed to facilitate informed choice, protect consumers and encourage legitimate business in the food industry.

However, EHPM argues in its manifesto that it is 'excessively restrictive' and it prioritises the protection of consumers over their desire for more information. 

As a result, the alliance argues that this regulation is stopping the use of innovation scientific research and is causing consumers to have to turn to uncontrolled sources of information, such as the internet, to get information about supplements' health benefits.

In 2015, the EC announced its plan to carry out a Regulatory Fitness and Performance evaluation (REFIT) of EU legislation on nutrition and health claims.

EHPM has been working with the EC to develop this and the staff working document should be published soon.

Regulatory proposal for botanicals

The manifesto points out that EHPM is working in cooperation with academics from EU members states to develop proper guidelines for the safety of botanicals.

As a consequence of the lack of a harmonised framework for botanicals, Article 8 of Regulation 1925/2006 is the legislative tool used to assess the safety of ingredients when safety concerns arise.

But the manifesto points out that the sector is experiencing an increasing use of this procedure by the European Commission prompted by certain members states and is sometimes driven by a product classification purpose as opposed to a safety concern. This leads to businesses having to provide cancerogenic and genotoxicity data in an unrealistic time period.

What’s more, EHPM says the lack of proper methodologies applied to the safety assessment of botanicals means the scientific evaluation tends to have negative outcomes.

The alliance has therefore created a regulatory proposal, suggesting a graded approach to evaluating botanicals, each supported by appropriate levels of evidence. The grades would include: 'Scientifically accepted' which could be validated with a high degree of certainty eg. ‘calcium contributes to the maintenance of normal muscle function’; 'Scientifically well-supported' which are validated by well-conducted clinical trials which are of sufficient quality to demonstrate an effect but are not conclusive; and ‘Traditional use’ substantiated with bibliographic evidence or industry data which must be demonstrated by reference to recognised publications.

Mutual Recognition

The manifesto points out that accessing the EU market has often been difficult for food supplement companies due to resistance from various Member States to comply with the Mutual Recognition Regulation.

EHPM contributed to a revised Mutual Recognition regulation (2019/515), that will become applicable as of April 2020, which it says should help facilitate the free movement of goods, including food supplements.

Arimont added:  “The EU has already updated its mutual recognition legislation last year, strengthening its exchange of information among national authorities and removing barriers to trade that impact smaller players, however our work is not done.

“It’s crucial that the EU objectives set out under the mutual recognition legislation are implemented at national level without any delay as of 2020.”

Acknowledgement of the term ‘probiotic’

The manifesto argues that the term ‘contains probiotics’ should be permitted in the EU to create a labelling environment that consumers can trust.

The document states: “While several national and international authorities worldwide have recognised the potential physiological and health benefits of probiotics and authorised such claims, little progress has been made at the EU level.”

E-commerce

The paper also calls for a ‘level playing field’ in the e-commerce sector to avoid unfair competition from countries with less strict rules.

Arimont explained: “It’s imperative to have a well regulated digital market place for the benefit of businesses and consumers to ensure a level playing field and do not face an unfair competition.

“Consumers should be able to trust the e-commerce sector and not be victims of misinformation regarding health benefits.”

General Food Law Regulation

What’s more, the association calls for implementation of meaningful pre-submission consultations between companies and EFSA in the revised General Food Law Regulation. This aims to ensure all elements of evidence needed to support applications for a product or claim authorisation could be open for discussion in detail, particularly in clinical trials.

Related topics: Regulation & Policy

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