News & Press Releases

Europe, Uncategorized

February 17, 2023

Product regulatory review 2022 and view 2023

An overview of essential changes in selected areas of product and environmental law for non-food consumer products

Overview

In view of the dynamic changes and complexity with which product law is currently developing, the overview presented, cannot claim to be complete. Rather, it is intended to give economic operators a first orientation and to be understood as a reference in the context of their “legal monitoring” of the legal minimum requirements during placing on the market or making available non-food consumer products of all kinds in Europe.

Due to the Corona pandemic (SARS-CoV-2 pandemic), the EU Commission also had difficulties in pushing forward its product regulatory agenda. The ambitious 2023 Commission work programme, with new legislative initiatives and the REFIT program to amend older legislation, can be viewed here.

The paradigm shift that has been underway for some time is recognizable here, in that Brussels is now increasingly turning to the instrument of a directly applicable EU regulation. This is gratifying in that within the harmonized goods market of the EU, legal provisions are also being subject to greater harmonization level. At the same time, however, the EU member states are being further restricted in their own national legal options. Overall, however, this development should have a positive effect on the EU-wide marketing and provision of products.

In the area of extended producer responsibility (EPR), on the other hand, it is already becoming apparent that the EU’s harmonization efforts are reaching their limits – more on this later.

General product safety – GPSR

On 21.12.2022, the final compromise text of the agreement in the EU trialogues (between the Parliament, the Council and the Commission) on the proposal for a new General Product Safety Regulation (GPSR) was published in the legislative procedure 2021/0170/COD with the document ST 16312 2022 INIT. This is a major step closer to publication in the Official Journal of the European Union. The GPSR will replace the General Product Safety Directive 2001/95/EC (GPSD) as well as the lesser-known Directive 87/357/EEC on products that can be confused with foodstuffs, thus providing far-reaching regulation for all consumer products. A more in-depth presentation of the upcoming innovations is reserved for a separate article. Also the other EU language versions will be published in the next days, under the document link mentioned above. A correspondence table at the end of the linked compromise text provides a first overview.

Every economic operator, whether he is a product-responsible manufacturer, importer or authorized representative, but also distributors, electronic marketplaces and fulfillment service providers, is advised to deal in detail with this regulation and the already valid Market Surveillance Regulation (EU) 2019/1020. The GPSR Regulation, which will then be directly applicable in all EU member states, could then come into force in the middle of next year 2024.

Chemical product safety – REACH

The REACH Regulation (EC) 1907/2006, which is decisive for chemical safety or material compliance, also received several updates in the form of amendments in 2022. A total of five different amendments have ensured that the EU’s “chemicals code” will continue to keep pace with scientific and technical progress in legislative terms.

For example, 24 substances are currently under evaluation – on a list maintained by the European Chemicals Agency (ECHA), whose development must be kept in mind for its medium-term product design. The Community Rolling Action Plan (CoRAP) is a tool used by the European Union (EU) to prioritize the risk assessment of substances that are already on the market and not yet fully listed under REACH. The CoRAP is updated annually and contains a list of substances that will be evaluated in the coming years by ECHA as the European scientific authority. This is to ensure that the most hazardous substances are identified and prioritized for risk assessment and risk management measures.

The draft provides for an annual update of the CoRAP and covers the three subsequent years 2023-2025. It includes substances suspected of endangering human health or the environment. Substance evaluation is the process under Articles 44 – 48 REACH, with the aim of clarifying potential risks from the use of these substances. The current draft CoRAP contains a total of 24 substances, including 6 new substances compared to the predecessor CoRAP 2022-2024; 5 substances are scheduled for evaluation in 2023, and 19 are split for evaluation in 2024 and 2025. Distributors must not disregard Annex XVII and draw practical consequences for their portfolio from the legal changes.

The POP Regulation (EU) 2019/1021 sometimes receives little attention in practice or is simply overlooked. This legal act is the implementation of the Stockholm Convention on Persistent Organic Pollutants within the EU and was supplemented for the sixth time in 2022.

Here, Annex I in particular should be reviewed for bans or limits, or Annex II for restrictions of substances in relation to many consumer products. Prominent substances in plastics in articles are e.g. short-chain chlorinated paraffins (SCCP), here the limit is 1500 ppm or polychlorinated biphenyls (PCB) in electrical appliances (ban by 31.12.2025). Hexabromocyclododecane (HBCD / HBCDD) is also still highly problematic in practice, e.g. in Styrofoam, and has been regulated with a limit of (only) 100 ppm.

Classification and labeling of chemicals

The classification and labeling of chemicals according to CLP Regulation (EC) 1272/2008 is also under examination.

The GHS (Globally Harmonized System) is a United Nations system for identifying hazardous chemicals and informing users of their hazards. Developed at the UN level, the GHS does not have immediate legal effect. It must first be made binding through implementation in the national legislation of individual states or communities of states. In Europe, this is done by the CLP Regulation. The amendments to the 17th ATP (Adaptation to Technical Progress) Regulation (EU) 2021/849 (application deadline: 17.12.2022) and 18th ATP Regulation (EU) 2022/692 (application deadline: 01.12.2023) must be taken into account.

In addition, a public consultation process is currently underway (here) from 20.12.2022 – 05.03.2023 regarding the revision of EU legislation on classification, labeling and packaging of chemicals. It is speculated that the EU will make its own classifications that go beyond the GHS.

Toys – TSD

Directive 2009/48/EC has been amended twice with legal effect in 2022.Here, too, the issue of converting the directive into a regulation is under discussion. Corresponding basic considerations can be found in the EU working paper SWD/2020/0287 final.

EPR area

(extended producer responsibility)

Contrary to what the generic term might suggest, the EPR is an obligation that only the economic actors responsible for the product have to fulfil. In short, the term “manufacturer” refers to those distributors in the respective EU member state who sells the B2C product to the end customer. These companies are then also in the focus of the respective national legislature, so they must make registrations in national registers in every legal area and then address quantity reports of the quantities they have sold there. With a Europe-wide sale of battery-powered electronics in end-customer packaging, there are therefore more than 100 registration obligations for companies across all countries.

The integration of EPR specialists, who provide strategic and/or operational support (make the respective quantity notifications) in fulfilling the legal obligations, is a good idea here.

Packaging

Packaging Directive 94/62/EC

In the area of European packaging law, the change in strategy, away from an EU directive to an EU regulation, is also being implemented. The necessary steps can be seen under the procedure 2022/0396(COD). The result is the proposed regulation COM(2022) 677 final, which will replace the previous EU directive 12 months after the new EU regulation enters into force.

Batteries and accumulators

The Battery Directive 2006/66/EC will be replaced by a regulation. The related procedure can be followed under 2020/0353/COD. New obligations will be imposed on economic operators that go beyond the existing requirements. Popularly overlooked in the context, but not included in the procedure, is Regulation (EU) 1103/2010 on rules for the indication of capacity on secondary (rechargeable) portable batteries and accumulators and on automotive batteries and accumulators.

Disposal of waste electrical and electronic equipment – WEEE

The Directive on Waste Electrical and Electronic Equipment 2012/19/EU WEEE was not adapted in 2022. However, the EU Commission conducted an evaluation to assess the progress and further development of this area of law with the public consultation from 06.10.2022 to 03.11.2022, which can be viewed here. The subject of frequent criticism was the lack of an effective mechanism to identify EPR free riders, because electrical and electronic equipment (EEE) supplied to the EU from third countries has so far been disregarded.

Overall, the EU still leaves much potential for harmonization in the area of EPR in terms of effective resource and recycling management.

In all three sub-areas, it is not creating a uniform category catalog with which the economic actors could work in a meaningful way. This catalog could also be the basis for a future European register and thus also the cornerstone for effective control by the competent authorities and ultimately significantly simplify the enforceability of the law. Instead, the EPR regulations are spreading nationally like a patchwork quilt, accompanied by national labels (Triman, sorting instructions in the national language, Info-Tri, Tidyman, recycling codes, Green Dot and much more). These processes are diametrically opposed to the basic idea of a single market for goods and should be addressed by the EU Commission. Unfortunately, neither the draft for the European battery regulation nor its counterpart in the packaging sector contains a better organizing European hand.

Chemical requirements for waste electrical and electronic equipment – RoHS

Directive 2011/65/EU RoHS for Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment has been legally adapted to scientific and technical progress once in 2022, with Annex III in particular regarding the use and transition periods of mercury in light bulbs likely to be of interest.

The Circular Economy Action Plan (CEAP), which counts electronics as a core product value within value chains, estimates that WEEE remains one of the fastest growing waste streams in the EU, with current annual growth rates of 2%.

Not least for this reason, the EU Commission had conducted a public consultation (see here) on the revision of Directive 2011/65/EU. In particular, the cumbersome and partly very non-transparent procedure in which exceptions and extensions of transitional periods are defined and published is often criticized. It is still being discussed whether the area of RoHS should be regulated as an independent instrument in the form of an amended directive, as a new regulation or as part of the REACH Regulation (EC) 1907/2006.

Electrical safety – LVD

Amendments to Directive 2014/35/EU regarding emergency procedures for conformity assessment are expected through procedure 2022/0280/COD.

Electromagnetic safety – EMC

Amendments to Directive 2014/30/EU are expected in relation to emergency procedures for conformity assessment through procedure 2022/0280/COD.

Radio equipment – RED

Directive (EU) 2022/2380 amending the RED Directive 2014/53/EU was published in the Official Journal of the European Union on December 7, 2022. The legislative procedure in the already completed procedure 2021/0291/COD can be viewed. It establishes USB Type-C technology as the standard charging port for the corresponding categories or classes of radio equipment.

Here, too, changes are to be expected with regard to emergency procedures for conformity assessment through procedure 2022/0280/COD.

Eco-design

A new Eco-design Framework Regulation is to replace the current framework legislation and thus Directive 2009/125/EC. The proposal COM(2022) 142 final states that significant changes are to be planned and introduced, leading in particular to more ecologically sustainable products. In particular, the digital product passport (DPP) should be mentioned here. The horizontal scope of application is also to be significantly extended beyond electrical products to include, for example, textiles. The procedure can be viewed under 2022/0095/COD.

Within the existing legal framework under the Eco-design Framework Directive 2009/125/EC, numerous implementing regulations are changing by tightening energy efficiency requirements and introducing new product groups covered by implementing measures. Electrical goods, textiles, furniture, steel, cement, and chemicals have been identified as potential product target groups. Thus, the existence of harmful chemicals will also be given greater consideration in the future. The overriding goal remains to reduce the environmental impact of products that are relevant to energy consumption, taking into account their entire life cycle. A selection of product groups and deadlines can be viewed here.

Single-use plastic – SUP

At this point, it is worth recalling the various implementation deadlines (addressed to the Member States, but affecting economic operators) of Article 17 of Directive (EU) 2019/904. This is visible in society, for example, in the packaging for fast food from which can be consumed immediately on the spot or taken away as a take-away dish. Thus, various obligations are introduced in the context of extended producer responsibility in the circular economy law. The Single-Use Plastic Fund Act (government draft: EWKFondsG), which was passed by the German Bundestag on 02.11.2022, sent to the Bundesrat and will apply from 2025, is, after the amendment of the national packaging law, the EWKVerbotsV and the EWKKennzV, the last national building block for the implementation of the SUP in the fight against single-use plastic products and the environmental problems they cause. The new law serves to establish a single-use plastic fund, which will be administered by the Federal Environment Agency (UBA). The UBA estimates that the 56,000 manufacturers of single-use plastic products affected will be held fiscally responsible and thus cover the costs of public and other waste disposal companies.

Food contact materials – FCM

Work is currently underway to revise EU regulations on food contact materials (FCMs). It is still unclear whether this will remain a mere revision or whether the process will even result in a recast of the entire legal framework under Regulation (EC) 1935/2004.

A public consultation on this is still running for a few days until 11.01.2023 and can be viewed here.

Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food is also being revised. For this purpose, the drafts of the 16th / 17th / 18th amendment are available. The adoption of amendment 16 is very advanced and includes the tightening of the specific migration limits (SMLs) for plasticizers/phthalates as well as the lowering of the SML totals for DEHP, DBP, BBP and DIBP, the removal of the entry for wood flour and additions of some other substances. Amendment 17 will entail some adjustments due to Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with food. Amendment 18 will likely include specific migration limits for titanium dioxide and styrene, although the ECJ ruling (not yet final) ref. T-279/20 of 23.11.2022 (summary here) on classification under CLP Regulation (EC) 1272/2008 as carcinogenic and the scientific procedures that will now follow will certainly still have to be taken into account.

An initiative is also planned for the Ceramics Directive 84/500/EEC, last adapted in 2005, to be transferred to a new regulation at the end of 2023; the consultation on this can be viewed here. Here, the considerations of the revision of the entire legal framework are likely to play a role.

Textile (fiber) labeling

With Regulation (EU) 1007/2011, textile labeling tends to lead a rather unnoticed existence. Regularly the subject of consultation, it forms the minimum regulatory requirements for the labeling of numerous consumer products. Legally convoluted and with many exceptions and tolerances extremely user-unfriendly, this regulation (according to information from the UBA to the author) will probably also undergo a revision in the next two years. However, the subject of the update is completely unclear to date. It would be nice to have a clear legal scope and simplification for the economic actors (e.g. inclusion of this information in the planned digital product passport in the field of eco-design).

Medical devices – MDR

As can be seen from a press release of the EU Commission from 06.01.2023, the transitional periods from the old MDD Directive 93/42/EEC are now to be extended by an adjustment of the current Regulation (EU) 2017/745. At the meeting of the Council (Employment, Social Policy, Health and Consumer Affairs) on 09.12.2022, the EU health ministers called on the Commission to quickly submit a proposal to extend the transition period in the regulation on medical devices. The European Parliament and the Council will now negotiate on the proposal. The press release mentioned above is available here.

Machinery

A new Machinery Regulation has been adopted and will replace the current Machinery Directive 2006/42/EC, publication expected in the first half of 2023. The course of the procedure and the final version will be available under 2021/0105/COD.

Timber regulation – EU TR

The EU TR Regulation (EU) 995/2010 and its implementing regulation on due diligence schemes (EU) 607/2012 are about to be replaced by a new regulation on products associated with deforestation and forest degradation in supply chains. The process is underway under 2021/0366/COD and a compromise text was submitted for adoption on 21.12.2022 with document ST 16298 2022 INIT. After an 18-month transition period, in addition to wood products, cattle, cocoa, coffee, palm oil, soy and rubber will now also be regulated and risk assessed for legal origin through a DDS (due diligence system) before being placed on the market.

For the timber trade regulatory area, the following tariff codes are noted:

4402 wood charcoal, 4404 hoopwood, 4405 wood wool, 4417 tools with wooden components, 4420 4421 other articles of wood, including 4421 20 coffins pulp and paper of chapters 47 and 48 of the Combined Nomenclature, and 4900 Printed books, newspapers, pictures and other products of the printing industry, manuscripts, typescripts and plans.

The practical implementation of this should also be interesting, with which one should prove the geodata of the concrete area of the origin of the goods. The newly introduced differentiation in the legal definitions between primary forest, other forested areas and naturally regenerating forest also requires closer examination, as does the planned exemption from due diligence obligations for SMEs if a due diligence declaration has already been submitted in accordance with Article 31.

Supply Chain Due Diligence Act

(DE)

Here, companies must in any case keep an eye on developments in the Corporate Sustainability Due Diligence Directive (CSDDD) and amending the (Whistleblower) Directive (EU) 2019/1937). An adaptation of the national LkSG in Germany will most likely be the result, with both tightening or simplification of sustainable supply chain management conceivable depending on the outcome of the negotiations. The progress of the proceedings can be viewed at 2022/0051/COD.

Artificial intelligence – AI

Proposal COM (2021) 206 final on a regulation laying down harmonized rules for artificial intelligence (AI). Procedural history: 2021/0106/COD. As in other sectoral product regulations, a conformity assessment procedure along with EU declaration of conformity and CE marking is foreseen.

Brexit

Finally, a note on the use of the CE marking and ɜ-marking (reversed epsilon for aerosols) in the United Kingdom (UK).

As reported by the British government, this will now be accepted until 31.12.2024, so that companies can use it as a replacement or alongside the UKCA marking. Admittedly, compliance with the legal minimum standards must still be documented and proven upon request.

Further updates and more detailed information on individual regulatory areas will be published here or at www.foxcompliance.eu.

Founder | Product Compliance Consultant
fox compliance GmbH · Germany
hello@foxcompliance.eu
www.foxcompliance.eu

admin

Uncategorized

March 9, 2022

Why you should take product compliance seriously!

What does product compliance mean?

This term refers to compliance with minimum public law requirements, i.e. those basic requirements that make it possible for products to be placed on the market for the first time.

If you are not aware of these public law regulations in relation to your specific product or if you not comply with these minimum legal requirements for product safety (electrical, mechanical, formal labeling), chemical safety, packaging licensing, eco-design, food safety and much more, that bears a risk of an import and trade ban on the affected products, their withdrawal from the market or their recall from the end consumer, (public) product warnings, and in the worst case fines, fines or even imprisonment. Simple labeling violations are sufficient.

_{What labeling is required for your product portfolio?}

Extensive specialist knowledge and relevant experience are therefore indispensable in order to preventively counteract all-round interventions and reputational damage, including those caused by (social) media. In the worst case, there is a risk of permanent entries in the relevant European warning portals RAPEX or RASFF. These digital, public pillory have a lasting effect on future entrepreneurial activity.

In summary, Product Compliance describes all legal, i.e. formal and material, requirements that a product must comply with when it is placed on the market (first time it is made available on the market) and when it is later made available on further sales levels.

Who does product compliance affect?

Basically everyone!

„Everyone is directly or indirectly affected by product compliance. In the morning you step out of the hopefully non-carcinogenic bedding in your pajamas. You put your toothbrush in your mouth until it comes into contact with the mucous membrane, use toothpaste with various ingredients. Later, you eat your breakfast and drink from what are believed to be food-safe materials. During the day you wear textiles and jewelry that should be free of harmful chemicals. You buy items and dispose of their packaging in dual systems, expectantly use apparently safe electronic, chemical or mechanical products.”
Sebastian Jockusch

All of this is product compliance and each of us is in contact with it every day at all times, whether we like it or not. In doing so, one trusts intuitively in the safe products. But are they really as safe as is often suggested?

Public regulatory law is primarily aimed at minimizing risks to life and limb, body and health and other protected assets (e.g. the environment, animals, property) for the user or third parties.

Preventive compliance with the relevant legal minimum requirements is addressed to those economic actors who place products on the market under their responsibility (manufacture or import them) or subsequently make them available on the market (trade with them). Making them available to the market for the first time means that they are commercializing the items to others for the first time. This can also be done free of charge as donations or gifts.

The legislature is uncompromising: countless national, European and international regulations regulate and enable market access for products.

_{Which directives and regulations must be observed for your product?}

Who controls the requirements?

Compliance with these relevant rules is then checked by the market surveillance authorities.

This can already lead to obstacles and problems with customs during the import process. In the worst case, this ends in the final rejection of the entire delivery at the external border with the EU. In an article here in the blog of our trustworthy cooperation partner Zollcoaching GmbH fox compliance GmbH has presented which important EU rules of product compliance must be observed so that goods can be brought through customs without complications and which challenges arise here.

But even within the harmonized goods market of the EU, products are controlled more and more closely.

Not only do the respective market supervisory authorities ensure a high level of control pressure (in Germany alone there are around 2000 different local and factually responsible authorities), but also fulfillment service providers and marketplace operators are increasingly scrutinizing their trading partners and checking compliance with the legal requirements beforehand the products are listed on your platform or in the marketplace.

With the entry into force of the new Market Surveillance Regulation (MÜ-VO) (EU) 2019/1020 (as of January 1st, 2021, in the final parts on July 16th, 2021), these actors were not only legally defined for the first time and included in the target group of obligated companies, but also the market surveillance landscape throughout the EU experienced a hitherto unknown level of harmonization. This collaborative approach enables better collaboration and leads to even more networked market surveillance actions.

What if something happens?

The case of non-compliance, i.e. non-conformity or confirmed non-compliance with the minimum legal requirements, can have significant consequences for those responsible. These then regularly meet legal entities but also their representatives, e.g. in the form of CEO’s, managing directors, department heads, etc., as natural persons.

This is particularly important when the violations result in a sufficiently probable endangerment of the protected goods (life, health, environment, property, etc.), which may have already resulted in concrete damage or simply violate applicable (product) law was violated.

public law

As already outlined, there is a threat of a comprehensive range of sovereign measures by market surveillance authorities in the public sector. These can vary depending on the intensity of the case and the degree of distribution (within the EU) of the affected products. This includes in particular the following measures by the responsible authorities:

manufacturing/import ban
trade prohibition
temporary measures until compliance is established
withdrawal from the trade
recall from end user
(public) product warnings
fines (administrative offences)
fines
jail terms

First of all, it should be noted that voluntary, appropriate measures by economic actors have priority over sovereign measures by the authorities. For this reason alone, the companies affected should, in their own interest, show a certain degree of willingness to cooperate in dialogue with market surveillance authorities in order to solve cases of non-conformity of their products immediately.

liability law

In the area of product safety, the principle applies that “a person responsible from the EU must have his full address on the product; whoever is named on the product is responsible for the product”. This does not mean any less that one is liable for one’s products in the market. This liability for disadvantages (e.g. damage) can on the one hand be of a contractual nature, i.e. arise from a purchase contract, contract for work or warranty contract or result from the Product Liability Act, producer liability from § 823 BGB or other legal provisions.

What is common to all bases for claims relevant in the individual case is that they possibly justify a liability claim for damages.

commercial/sales law

In this area, too, deviations from the legal regulations can lead to complaints from the customer and thus to the taking back of goods in the B2B area. Customers and thus to the taking back of goods in the B2B area.

According to the literature, the absence of the CE marking in the B2C area represents a purchase defect (§ 434 Para. 1 BGB) and can trigger warranty claims by the buyer against the trade, which in turn will take recourse against the product manager.

competition law

As a “sharp sword” and effective remedy against non-compliant goods, authorized institutions (list of qualified business associations maintained by the Federal Office of Justice) under the Act Against Unfair Competition (UWG) or competitors in the context of competition law procedures (warning letters, court) can also ensure that non-compliant (non-compliant) products (must) be withdrawn from the market quickly

criminal law

The aspects of criminal law must not be ignored, especially if the offenses were committed intentionally or systematically (e.g. by failing to organize appropriate company processes).

Relevant ancillary criminal law, for example ProdSG, LFGB, ChemSanktionsV i.c.w. ChemG

criminal code (act intentionally or negligently)

environmental damage
arson
physical injury
killing

reputational damage

In addition to the legal and associated economic consequences described, the affected company or its brand is also threatened with immaterial damage.

These can have a bad effect on supplier scoring, for example, or result in negative ratings in portals or product reviews. Temporary shitstorms are just as bearable as critical media or consumer magazines / organizations. All in all, fast and transparent communication with all stakeholders – from the end consumer, affected economic actors to media representatives – has the highest priority. Only through professional processing can damage to your good reputation or that of your products be limited and subsequently restored.

Don’t let it happen!

Responsibility is known to be indivisible and cannot be delegated 100% within the framework of product compliance by the managing directors of affected companies. Nevertheless, “firewalls” can be installed preventively in many places and thus the risk of having non-compliant goods in the portfolio can be significantly reduced.

fox compliance GmbH supports you as a product manager in the area of consumer products, in particular with the following points:

practical advice on the requirements
evaluation of existing test reports
notes on missing test reports
risk assessment, due diligence system (DDS)
recommended literature + judgment database
technical papers
internal process design
development of properties in the ERP system (PIM / PCM)
project-based interim solutions
assement / mentoring
communication with authorities
mediation of specialist staff

In addition to our own expertise, we offer an extensive network of well-known experts – with together hundreds of years of practical experience – in the field of product compliance:

accredited laboratories & test centers
custom experts
extended producer responsibility (EPR)
licensing (WEEE, batteries, packaging, …)
refurbishment of defective goods
disposer
recycling-specialists
Product Compliance experts (almost all regulations)
highly specialized lawyers

contact us – we are happy to conduct a free initial consultation!

admin

Europe, food, food supplements

August 31, 2021

food supplements

a daily companion for many people

How are these food supplements legally classified?

Within the harmonized EU market, food supplements (NEM) fall under food law in accordance with the (food) Basic Regulation (EC) 178/2002 and are accordingly strictly regulated.

Article 2 postulates: “For the purposes of this Regulation, ‘food’ (or ‘foodstuff’) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.“

The responsibility for the safety of these preparations lies with the so-called food business operator, i.e. the actor who puts the item on the market (makes it available on the market for the first time). The far-reaching definition of food companies includes not only commercially active economic operators but also private, natural persons, even if they do not intend to make a profit. Even giving away the tomatoes grown on the terrace free of charge, or even just keeping them ready, unconsciously turns the hobby gardener into a food entrepreneur de lege lata.

Within this general legal framework for food, the European legislator has created a framework for special foods with the Food Supplements Directive 2002/46/EC.

These are products that contain concentrated amounts of nutrients or other substances that are intended to supplement normal nutrition. These substances must have a nutritional or physiological effect and be put on the market in a specially dosed or dosed form. This can take the form of capsules, tablets, pills, lozenges, powders, ampoules or even bottles with dropper inserts.

In addition, a dense regulatory network was set up and further European harmonized regulations established (links all lead to the consolidated versions):

(EC) 1925/2006 addition Regulation

(EC) 1924/2006 nutrition Regulation

(EU) 1169/2011 food information Regulation

(EU) 609/2013 food intended for infants and young children, food for special medical and diets purposes Regulation

(EU) 2015/2283 novel food Regulation

Due to their legal character, they apply directly in every EU member state and thus have a great harmonizing effect. Nevertheless, this “jungle of regulations” with different characteristics, objectives and amendment dynamics sometimes causes confusion among practitioners.

In addition to the fragmentation into various legal acts, the classification of the substances used regularly causes problems in practice and is consequently often the subject of disputes in competition and administrative law proceedings.

Which ingredients can be used?

However, specifications regarding recipe labeling are only made for vitamins and minerals (Annex I) and the substances used as their sources (Annex II). There are currently no mandatory maximum or minimum quantities for the ingredients of food supplements specified in the European Union.

For ingredients that are neither vitamins nor minerals, the EU Commission has issued the special harmonized regulations outlined above to protect consumers from possible health risks. Here, substances may have to undergo an authorization, acc. to the (EU) 2015/2283 novel food Regulation or at least a notification. It also maintains a “Novel Food Catalog” list of substances which are known or suspected of having harmful effects on health and whose use is therefore monitored

In addition to the substances that are added for nutritional purposes, food supplements can also contain food additives, i. H. Substances that are added to the products for technological reasons (e.g. coating agents for tablets, sweeteners). Regulation (EC) 1333/2008 on food additives provides a list of the additives that are approved for use in food supplements.

Substances whose use in food is prohibited or subject to restrictions or whose use is being examined are listed in Annex III of Regulation(EC) 1925/2006 on addition info.

Substances that do not fall into the above-mentioned categories can, subject to the provisions in the specific national legal provisions, still be contained in food supplements and possibly offered on national markets in the EU member states.

Which labeling is mandatory for food supplements?

The directive on food supplements 2002/46/EC extends to all food supplements regarding the general labeling requirements. In addition, the above legal framework results in further labeling requirements (list is not exhaustive):

designation as a food supplement

EU food business operators
list of ingredients
additives
quantities (Directive 76/211/EEC)
best before
lot / batch number
nutrition declaration
note on daily consumption
warning notice “daily dose”
warning notices “no substitute for a varied diet”
warning notice “reach small children”
no unproven “health claims”
information on storage and use
legibility, language, durability

The so-called “health claims” must not attribute any properties to foodstuffs in their presentation or advertising that serve to prevent, treat or cure a human disease, or refer to such properties. Among other things, this serves to distinguish it from medical device law and drug law and, finally, preventive consumer protection.

Who controls compliance with the legal minimum requirements?

Placing food supplements on the market is the responsibility of the manufacturer, importer, supplier or dealer. This group of actors is responsible for ensuring that a food supplement placed on the market is safe.

As in other product law areas, there is a network of competent market surveillance authorities which monitor the manufacture, import and trade of NEM. In order to facilitate the controls and to be able to identify unsafe products at an early stage, there is an obligation to notify before an NEM is placed on the market within the territory of the respective EU member state.

Conclusion

The distributors are faced with a complex set of rules, the protective purpose of which is preventive health and consumer protection, which is strictly controlled.

If you ignore it, you are exposed to a not inconsiderable legal risk. There is a threat not only of bans on the sale of goods, monetary or criminal sanctions, but also warnings that damage the company’s reputation, e.g. via the relevant RASSF Portal of the EU Commission.

Even if this food area does not fall under the New Legislative Framework (NLF) – which is very regrettable – the new Market Surveillance Regulation (EU) 2019/1020 does not apply here, it is also determined in eCommerce and on other platforms. Here it is increasingly the fulfillment service providers (like Amazon) and marketplace operators (like eBay) who control the requirements more closely. In general, competitors and consumer protection organizations also ensure regular civil law court proceedings.

Every responsible food business operator, including those who bring food supplements into the market, would do well to find out about the minimum legal requirements before placing supposedly safe products on the market.

Technical documentation and laboratory tests, preferably in English due to their EU-wide recognition, are urgently required for this. It is also advisable to check the labeling, as packaging law and product law collide here.

admin