CE Marking – The CE marking indicates that a product is in compliance with all relevant European Economic Area (EEA)   legislation, making it eligible to be marketed and sold throughout the EEA. The EEA consists of the European Union (EU) and the European Free Trade Association (EFTA)  . By affixing the CE marking on a product, a manufacturer is declaring conformity with all relevant legal requirements, specifically those ensuring health, safety, and environmental protection. CE marking applies to the following product groups: active implantable medical devices, appliances burning gaseous fuels, cableway installations designed to carry persons, construction products, eco-design of energy-related products, electromagnetic compatibility, equipment for use in potentially explosive atmospheres (ATEX), explosives for civil uses, hot-water boilers, household refrigerators and freezers, in vitro diagnostic medical devices, lifts, low voltage, machinery, measuring instruments, medical devices, noise emission in the environment, non-automatic weighing instruments, personal protective equipment, pressure equipment, pyrotechnics, radio equipment and telecommunications terminal equipment, recreational craft, restriction of hazardous substances in electrical and electronic equipment, safety of toys, and simple pressure vessels. CE marking does not apply to items such as chemicals, pharmaceuticals (including cosmetics), and foodstuffs.

Conflict Minerals Regulation – On 1 January, 2021 the Conflict Minerals Regulation will come into full force across the EU. It aims to help stem the trade in four minerals – tin, tantalum, tungsten and gold (3TGs) – which sometimes finance armed conflict or are mined using forced labour. The EU regulation aims to 1) ensure that EU importers of 3TGs meet international responsible sourcing standards, set by the Organization for Economic Co-operation and Development (OECD), 2) ensure that global and EU smelters and refiners of 3TGs source responsibly, 3) help put an end to the exploitation and abuse of local communities, including mine workers, and support local development. 

EU Medical Device Regulation – The EU Medical Device Regulation 2017/745 came into force in 2017 and has a staggered transitional period of three years. The MDR will fully apply beginning 26 May 2020. This regulation places restrictions and reporting requirements on substances used in the design and manufacturing process of medical devices. The regulation restricts substances known to be carcinogenic, mutagenic or toxic to reproduction above a certain threshold, as well as substances known to have endocrine disrupting properties. It mandates that if such substances are present, they must be clearly labeled on the device itself and/or on the packaging. There are certain cases in which companies must also provide precautionary warnings, such as when the device is intended to treat children or pregnant women. 

EU Packaging Directive – The Directive 94/62/EC on packaging and packaging waste went into effect on June 30, 1996. The Directive aims to harmonize national measures and reduce the environmental impact of packaging by reducing packaging at the source, maximizing the recovery of used packaging, and eliminating harmful materials from supply chains. All household, commercial and industrial packaging waste marketed in the European Union is in scope of the regulation. The regulation set up a national database so implantation can be monitored, and it covers how much packaging waste should be recovered vs. recycled among and sets limits for heavy metal contents, among other specifics.

The Directive includes primary packaging for an individual product, secondary packaging for the case of a product, and tertiary packaging for shipping and handling of a product. It includes packaging used at any stage of manufacturing: from raw material to finished product. Packaging includes items that are filled at the point of sale, such as cups, plates and bags which are used in food service. Packaging does not include items that are integral to a product; and in which are intended to be used, consumed and disposed of together, such as a coffee bags or seedling pots. 

EU POP Recast Regulation – Persistent Organic Pollutants (POPs) are organic chemical substances that persist in the environment, bioaccumulate through the food chain, and cause adverse effects to the environment and human health. The EU POPs regulation implements the Stockholm Convention on Persistent Organic Pollutants (POPs) and restricts or bans the manufacturing, marketing, and use of POPs in EU. The recast of POPs regulation aligns certain terms and definitions with those in the REACH regulation and the EU Waste Framework Directive. It also updates the substances listed in Annex I.

The EU POPs Regulation contains 4 annexes.

Annex I – List of substances subject to eliminationAnnex II – List of substances subject to restrictionAnnex III – List of substances subject to release reduction provisionsAnnex IV – List of substances subject to waste management provisions

EU REACH Restrictions – The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation   came into effect in 2007. REACH restricts the use of certain hazardous substances in products made and sold in the European Union (EU) and it places the burden of proof on companies that use chemicals in their products. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risks of use to consumers/users. 

Under REACH, there is a list of restricted substances that qualify as Substances of Very High Concern (SVHC) if one of the following is true. They are: 

carcinogenic, mutagenic or toxic to reproduction (CMRs);persistent, bioaccumulative and toxic (PBTs);very persistent and bioaccumulative (vPvBs);seriously and/or irreversibly damaging the environment or human health, as substances damaging the hormone system;

EU RoHS Recast Directive – The EU RoHS (Restriction of Hazardous Substances) Directive   is also known as Directive 2002/95/EC. The directive restricts the use of specific hazardous materials found in electrical and electronic products. All applicable products in the EU market sold after July 1, 2006 must pass RoHS compliance or they can be re-called and removed from shelves. The substances banned under RoHS are lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (CrVI), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and four different phthalates (DEHP, BBP, DBP, DIBP). All substances are restricted at 1000 ppm per homogenous material except for cadmium, which is restricted at 100 ppm. DEHP, BBP, DBP and DIBP have been restricted since 22 July 2019, except for medical devices and monitoring and control equipment, which come into effect 22 July 2021.

WEEE Directive Recast (Directive 2011/65/EU) – The WEEE Directive sets criteria for the collection, treatment and recovery of waste electrical and electronic equipment in the EU. Companies who place electrical and electronic equipment (EEE) on the EU market (both producers and distributors) have obligations under the WEEE regulations. The objective of the directive is to promote re-use, recycling and other forms of recovery of waste electrical and electronic equipment (WEEE) in order to reduce the quantity of such waste to be disposed and to improve the environmental performance of the economic operators involved in the treatment of WEEE.

EU Battery Directive 2006/66/EC (Amendment 2013/56/EU) – The EU Battery Directive (2006/66/EC)   regulates the manufacturing and disposal of batteries and accumulators in the EU to protect human health and the environment from hazardous substances. The Directive requires producers to restrict the amounts of Hg and Cd, properly label their battery products, and finance collection/recycling/public awareness programs for battery waste disposal. Companies are required to comply with the Directive responsibilities in order to avoid fines and shipping barriers upon import into any of the 27 EU Member States. 

Tax on Chemicals in Certain Electronics Law 2019:489 (Sweden Flame Retardant Tax) – This regulation mandates that a tax be paid on certain EEE products when they are placed on the market in Sweden. A tax reduction is available if the products can be shown to not contain the flame retardants bromine, chlorine, or phosphorus. The newest version of the law took effect in June 2019.

EU Waste Framework Directive – The EU Waste Framework Directive gives ECHA the task to develop a database with information on articles containing substances of very high concern (SVHCs) on the Candidate List. New substances are regularly added to the Candidate List under REACH. The database, called the   EU SCIP Database, will contain information submitted to ECHA by companies that produce, import or supply articles containing Candidate List substances. These articles can be produced in the EU or imported from non-EU countries.

Regulation (EU) 2017/852 (EU Mercury Regulation) – Regulation (EU) 2017/852 covers the full life cycle of mercury. It complements a large body of existing EU environmental law on mercury by 1) Prohibiting the manufacture, export/import of a large range of mercury-added products, 2) Reducing the use of dental amalgam, 3) Limiting future new uses of mercury in industry and in products, 4) Ensuring that all mercury waste is safely taken out of the economic sphere, stabilized in a less toxic form and stored permanently in sound conditions. 

UK Modern Slavery Act (UK only) – Every organization operating a business within the UK, with a total annual turnover of £36m or more, is required to produce a slavery and human trafficking statement for each financial year of the organization.