SPACEGOATS

A Guide to European Product Compliance and Requirements

9. August 2022

Table of Contents
a-guide-to-european-product-compliance-and-requirements

Let’s talk product compliance and requirements! Amazon has blocked your listing? Have you been contacted by customs or a market surveillance authority? You have received a warning under competition law regarding one of your products? You have to comply with legal reporting obligations, e.g. in relation to your packaging, electrical goods or batteries – but don’t know how? You have to pro-actively provide SPACEGOATS with test reports?

If you are concerned about one of these or other similar topics, you should read the following information on product compliance carefully!

Every economic operator – including you – is obliged by law to place only safe products on the market within the internal market of the 27 member states of the European Union (EU) and the European Economic Area (EEA) [Iceland, Norway, Lichtenstein]. This serves, among other things, consumer protection and thus all of us!

This affects the companies responsible for manufacturing or importing products on the one hand:

  • Manufacturers
  • Importers
  • EU authorised representatives

and on the other hand the companies involved in the distribution of the products:

  • Distributors
  • Wholesalers
  • Fulfilment centres
  • Marketplaces

Product Compliance in the EU and UK

Consumer products are generally subject to general product safety legislation as well as other specific product legislation, such as chemicals legislation. Product safety law is divided into different European and national legal provisions. It should be noted that EU directives must be transformed into national law (sometimes with deviations), whereas EU regulations apply 1:1 directly in all EU member states as well as in the EEA.

The requirements in the United Kingdom (UK) are similar. The general product safety regulations in the UK are laid down in Regulation 2005 No. 1803 “The General Product Safety Regulations 2005” (UK-GPSR). Analogous to the EU, these legal standards are intended to ensure that only safe products are made available to consumers in the UK and thus address obligations to the above-mentioned economic actors in a similar manner. Consequently, different rules apply to goods offered and sold in the UK (England, Scotland and Wales). By 31.12.2022 at the latest, separate rules must be implemented in the UK and observed in the sale of goods. There are also special rules for Northern Ireland (NI) in order to be able to offer both EU goods and UK goods as marketable there. More on this at the end of this article.

Why you need to care about product compliance

It is the responsibility of each individual economic operator in their role to comply with the legal requirements that apply to their products. As part of this product responsibility, you must research and understand these requirements and prove the compliance of your product with these minimum legal requirements via a test report.

ATTENTION! You can always do more for your products (e.g. quality) – but never less than what the legislator requires in terms of product safety.

Companies that manufacture products themselves, have them manufactured or import them into the EU from a third country must prove that their articles meet the legal requirements. Consumers must also be informed about risks associated with products and non-compliant or dangerous goods must be removed.

Traders, wholesalers, fulfilment centres, marketplaces are obliged to act with due diligence to assist in complying with the applicable safety requirements. They shall not make available on the market products which they know or should assume, based on the information they have or lack, do not comply with the relevant safety requirements.

As a retailer, the SPACEGOATS are therefore also obliged to check product conformity. In this way, the SAPCEGOATS comply with their own legal obligations and support you, as usual, in being successful with Amazon. Amazon, in its role as a fulfilment centre, is also obliged to check all offers and will do this more and more systematically in the future in order to simply exclude offers in case of doubt!

For this reason, it is also important that you know and demonstrably comply with the legal and technical, chemical and other existing requirements (e.g. labelling, warnings) that apply to your product.

It becomes clear that you have to deal with the topic of product safety in your own role. Whether you import products from a third EU country (e.g. China, USA, Brazil) or trade in articles, in your own role you have legal obligations that are not transferable to third parties.

Basic requirements of the EU General Product Safety Directive that you must know, comply with or at least check in any case

The General Product Safety Directive 2001/95/EC (GPSD) is the standard for the basic legal minimum requirements. It applies to all consumer products, i.e. in any case also to your product! These requirements must be met in order for products to be placed on the market or traded (made available) as marketable in the EU/EEA. Products must therefore be safe and this level of product-specific safety must be proven in a suitable form (e.g. test reports).

The GPSD directive is implemented in Germany by the law on the provision of products on the market – in short: Product Safety Act (ProdSG).

In addition to inherent safety, i.e. the safety inherent in the respective product when used as intended and also in the case of foreseeable (mis)use, simple formal labelling requirements must also be met. These can and are checked by every actor and also by market surveillance authorities – previously even by customs.

This includes clear labelling with:

  • Identification features of the article (e.g. article number, batch number).
  • Identification features of the EU person responsible (complete postal EU address)
  • Warnings and safety instructions (in the official language of the country of sale)
  • Instructions for its assembly, installation, maintenance and service life.

If your article is already lacking one of the necessary identification features, action is called for. Critical economic actors are advised to take a look at §§ 3 and 6 ProdSG, which apply to Germany. Similar regulations, which originate from the GPSD, apply in every EU/EFTA member state, as well as in parallel for the UK goods market.

Further selected and non-exhaustive information on EU requirements, which admittedly do not constitute legal advice, has been compiled for you by the SPACEGOATS below.

Special requirements of other product compliance regulations in the EU

In addition, depending on the product category, products must cumulatively fulfil the requirements of various other EU legal provisions. The following non-exhaustive list of relevant regulations in product law should help you to keep an overview.

All types of packaging

Packaging Directive – Requirements for all packaging

Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste
*chemical requirements for packaging and participation in dual waste recovery systems

Chemical requirements for all products

REACH Regulation

Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency
*chemical requirements for all articles, substances, mixtures

POP Regulation

Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants.
*chemical requirements for certain articles, substances, mixtures

GHS-/CLP Regulation

Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.
*chemical requirements for the labelling of substances, mixtures or articles containing substances

Detergents Regulation

Regulation (EC) 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents
*chemical requirements for detergents and similar products

Aerosol packaging

Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers
*safety and formal requirements for the labelling of aerosol dispensers (e.g. sprays)

Cosmetics Regulation

Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
*chemical and formal requirements for the labelling of cosmetics

Biocide Regulation

Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
*chemical and formal requirements for the labelling of biocidal products or treated products that have an “anti-effect” on organisms.

Requirements for electrical and electronic products

Chemical requirements for electrical products (RoHS) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
*chemical requirements for all electrical products

WEEE Directive

Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment.
*formal requirements for labelling and participation in the Dual System for WEEE of almost all electrical products

Electromagnetic compatibility (EMC)

Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility.
*Electromagnetic requirements of almost all electrical products (see RED Directive).

Low Voltage Directive (LVD)

Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of Member States relating to the making available of electrical equipment designed for use within certain voltage limits.
*Safety requirements of all electrical products in the range of 50V-1000V alternating current or 75V-1500V direct current.

Directive for Radio Operated Electrical Products (RED)

Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available of radio equipment.
*Radio technical requirements of certain electrical products (e.g. radio powered, WiFi, Bluetooth, etc. – see EMC Directive).

Requirements for batteries and accumulators

Battery Directive

Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators.
*chemical and formal requirements for marking and participation in the Dual System for primary batteries and secondary batteries (accumulators)

Accumulator Regulation

Commission Regulation (EU) 1103/2010 of 29 November 2010 laying down rules for the indication of capacity on portable secondary (rechargeable) batteries and accumulators and on automotive batteries and accumulators.
*Further formal requirements for the labelling of secondary (accumulator) batteries.

Requirements for toys for children up to 14 years of age

Toys Directive

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys
*Formal, mechanical, chemical and other requirements for toys for children up to 14 years of age; also labelling and warnings.

Requirements for personal protective equipment

PPE Regulation

Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment.
*Safety requirements for all personal protective equipment

Requirements for food contact materials and articles

Food Contact Material Framework Regulation

Regulation (EC) 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with foodstuffs.
*Basic requirements for the food contact safety of products intended to come into or foreseeable contact with food.

Food Contact Material Plastic Regulation

Commission Regulation (EU) 10/2011 of 14 January 2011 relating to plastic materials and articles intended to come into contact with foodstuffs.
*Specific requirements for the food contact safety of plastic materials and articles intended or likely to come into contact with foodstuffs

Food Contact Material Melamine Regulation

Commission Regulation (EU) 284/2011 of 22 March 2011 laying down special conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People’s Republic of China and the Hong Kong Special Administrative Region, China respectively.
*Special requirements for food contact safety of products made of plastic and of specified origin with intended or foreseeable food contact.

Ceramics Directive

Council Directive 84/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs.
*specific requirements for the food contact safety of ceramic products intended or likely to come into contact with foodstuffs.

Requirements for certain timber products or timber-based articles

EU TR – Timber Regulation / Holzhandelsverordnung

Regulation (EU) 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market.
*special requirements for products made of wood, paper, board or other wood-based composite materials from outside the EU and customs code listed in the Annex

Requirements for certain protected animal and plant species

CITES Regulation implementing the Washington Convention on International Trade in Endangered Species of Wild Fauna and Flora Council Regulation (EC) 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein.
*Distribution bans, permit reservations for certain animal or plant species, e.g. also wood, coral, ivory, etc.

Requirements for food supplements

Framework Directive on Food Supplements

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.
*Basic requirements for food supplements

Health Claims Regulation

Regulation (EC) 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods.
*special requirements for the advertising of and claims made on food supplements

Health Claims List Regulation

Commission Regulation (EU) 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health.
*specific list of health claims for the advertising of and claims made on food supplements.

Fortification Regulation

Regulation (EC) 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods.
*special requirements for the addition of certain additives to food supplements

Food Law Basic Regulation

Regulation (EC) 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
*Basic requirements for food supplements/foodstuffs

Additive Regulation

Regulation (EC) 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives.
*special requirements for the addition of certain additives to food supplements/foods

Novel Food Regulation

Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods.
*Principal requirements for specific food supplements/foods.

FSG Regulation on foods for specific consumer groups

Regulation (EU) 609/2013 of the European Parliament and of the Council of 12 June 2013 on foods for infants and young children, foods for special medical purposes and daily rations for weight control diets.
*General requirements for specific food supplements/foods

Requirements for fibre labelling of textiles and textile articles

Regulation (EU) 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of fibre composition of textile products. *Formal requirements for the labelling of textile products and certain textile components (>80% textile content).

Requirements for the labelling of footwear products

Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of materials used in the main components of footwear for sale to the consumer.
*Formal requirements for the labelling of footwear, footwear products and certain components used.

Requirements for medical devices

MDR Medical Devices Regulation Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices.
*Safety requirements for all medical devices of different classes.

Requirements for machinery

Machinery Directive

Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery.
*Safety requirements for all machinery

Requirements for construction products

Construction Products Regulation

Regulation (EU) 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products.
*Safety requirements for all products classified as construction products

Worldwide requirements for the safe transport of dangerous goods

There are also global requirements for the safe transport of goods classified as dangerous. Special tests, labels or shipping documents may have to be used for this purpose.

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Basic product safety requirements in the UK / NI

As already mentioned, since the BREXIT, the United Kingdom (UK) has its own requirements with which you must be familiar if you want to offer articles there.

The general product safety regulations in the UK are laid down in Regulation 2005 No. 1803 “The General Product Safety Regulations 2005” (UK-GPSR). As in the EU, the UK GPSR are designed to ensure that only safe products are made available to consumers in the UK. Other legislation similarly defines its own legal requirements for the UK market.

You should note that UK companies based in the EU are considered importers and not distributors. Therefore, before entering the articles into the system, check whether your products are freely tradable on the UK market or whether they have to be labelled and tested differently! The UKCA marking must be affixed to almost all items bearing the CE mark in the EU. This requires prior testing by UK approved testing bodies. For goods offered and sold in the UK (England, Scotland and Wales), different rules apply, namely those of the UK market. By 31.12.2022 at the latest, the rules set in the UK must be implemented and observed in the sale of goods. The British government provides current guidelines for the implementation of the product regulations here.

ATTENTION: From 1 January 2023, the CE mark for the United Kingdom (excluding Northern Ireland) will lose its significance as a market authorisation mark for products.

As a special regulation for Northern Ireland (NI), the Northern Ireland Protocol will apply from 01.01.2021. This will be reviewed every 4 years and adapted if necessary. As long as it is in force, NI will adapt to all relevant EU regulations regarding the placing of goods on the market. For the goods market in NI, it must therefore be ensured that the products continue to comply with the EU requirements outlined above. This concerns both the labelling, e.g. with EU conformity markings, an EU or NI address, and compliance with relevant safety requirements. “Qualifying goods from Northern Ireland” can be sold in GB with the CE mark. However, the UKCA marking does not apply to goods to be sold in NI. More information on the interaction of the rules is available here. The UK government is successively issuing guidance on which goods are affected and how product conformity can be demonstrated in a legally secure manner.

If you have any further questions, please do not hesitate to contact our external compliance advisor:

Fox Compliance
Sebastian Jockusch
https://foxcompliance.eu

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