Heavy Metals Regulations in the European Union: An Overview

Heavy metals can be found in everything from jewelry and watch cases to electronic components and toy paints. While lead, cadmium, mercury, and other heavy metals serve a purpose – these substances are also strictly regulated in the European Union.

Keep reading, and learn what you must know about EU heavy metals regulations, including REACH, RoHS, and much more.

What is considered a heavy metal?

Heavy metals are generally defined as metals with relatively high densities, high atomic weight, or high atomic number. The definition of heavy metals is not always fixed and might change depending on the context and subjects.

Various kinds of heavy metals and their compounds can be found in petroleum products, which constitutes a wide range of consumer products like cosmetics, personal care products, food contact products, medical devices, and electronics.

Heavy metals, such as lead, are also used in paints, dyes, and inks, in order to accelerate drying, increase durability, to delay corrosion. Finally, heavy metals might already exist in the raw materials used to manufacture the products.

Here is a list of some of the most common and regulated heavy metals:

• Lead
• Mercury
• Nickel
• Chromium
• Arsenic

Are heavy metals banned in the European Union?

Heavy metals are not completely banned in the European Union. However, they are restricted as exposure to heavy metals is proven to cause various diseases and dysfunctionalities in the human body.

For example, long-term exposure to lead might cause learning, language, and behavioral problems to young infants and children. Mercury is linked to the nervous system, reproductive, immune, and respiratory toxicity. Chromium is linked to asthma, chronic bronchitis, rhinitis, congestion, and hyperemia.

The EU and the individual member states have regulations restricting the content concentration of certain types of heavy metals in some consumer products, including:

• REACH
• RoHS Directive
• Toy Safety Directive
• Regulation (EC) 1223/2009 on Cosmetics Products
• Regulation (EC) 1935/2004 on Food Contact Materials

Which products and materials may contain heavy metals?

It’s fair to say that almost any product can contain heavy metals because they can be found in paints, metal alloys, or petroleum-based products. Paint can be applied to any material so it’s a risk that spans all products.

Having said that, below we list some of the most common products that might contain heavy metal, for which specific regulations exist.

Food Contact Materials

Food contact materials might mainly contain lead, chromium, cadmium, copper, nickel, titanium, or mercury.

Here are a few product samples:

• Infants’ feeding bottles
• Teethers
• Sippy cups
• Plastic food containers
• Paper food packaging
• Ceramics tablewares

Cosmetics

Cosmetics and personal care products might mainly contain lead, mercury, arsenic, mercury, aluminum, zinc, or chromium.

Here are a few product samples:

• Lipsticks
• Eyeliners
• Foundations
• Concealers
• Moisturizers
• Nailpolish
• Whitening toothpaste

Electronics Devices

Electronics devices might contain mercury, lead, gallium, selenium, arsenic, zinc, cobalt, tin, palladium, or aluminum.

Here are a few product samples:

• Printed circuit boards
• Computer monitors
• Chip resistors and semiconductors
• Cables
• Motherboards

Toys

Toys might contain lead, cadmium, zinc, chromium, or bromine.

Here are a few product samples:

• Painted wooden toys
• Plastic toys
• Plush toys
• Metal toys

Batteries

Batteries might contain mercury, cadmium, lead, lithium, manganese dioxide, silver, nickel, or zinc.

Here are a few product samples:

• Lithium-ion batteries
• Lithium-ion polymer batteries
• Lithium metal batteries

Packaging

Packaging might contain mercury, lead, cadmium, and hexavalent chromium.

Here are a few product samples:

• Watch boxes
• Cardboard boxes
• Plastic packaging
• Food and beverage packaging

Heavy Metal Product Regulations Overview

REACH

REACH establishes maximum concentration limits for heavy metals, and other dangerous substances such as Phthalates or Bisphenol A, in consumer products. The restricted heavy metals are recorded in the Annex XVII of the regulation.

The specific concentration value heavy metals allowed might vary according to the product and the heavy metal that we take under consideration. For example, an amendment of REACH’s Annex XVII requires that the concentration limit for textiles, clothing, and footwear should be less than 1mg/kg – for the following substances:

• Lead and its compounds
• Cadmium and its compounds
• Chromium VI
• Arsenic

However, for jewelry products like bracelets, necklaces, watches, and rings, the concentration of lead should not be greater than 0.05 % by weight.

Below we list some of the most common heavy metals regulated by REACH, which might be found in medical devices, jewelry, textiles, cosmetics, electronics, food contact products, and other types of consumer products.

Mercury

REACH forbids the use of mercury in fever thermometers, manometers, barometers, sphygmomanometers, and thermometers.

Nickel

REACH regulates the nickel migration levels of jewelry products and accessories such as:

• Earrings
• Necklaces
• Bracelets
• Anklets
• Rings,
• Wrist-watch cases, watch straps and tighteners
• Rivet buttons
• Zippers
• Metal marks

The migration level of nickel for parts like pins, needles, or parts that will pierce through the body should be less than 0.2 μg/cm2/week. Parts that are designed to come into direct or indirect contact with the body should have a migration rate of fewer than 0.5 μg/cm2/week.

Cadmium

REACH prohibits the use of cadmium in amounts equal to or greater than 0.01% by weight in synthetic organic polymers, including the following ones:

• PVC
• PP
• Polyurethane
• High-impact polystyrene
• Epoxy resins

Chromium

REACH requires that Chromium VI Compounds used in leathery products like boots, purses, textiles should not exceed 3 mg/kg.

Antimony

REACH requires that the migration limit of Antimony from PET bottles and other food packagings should not exceed 40 mg/kg.

RoHS Directive

The RoHS Directive establishes rules on the restriction of the use of hazardous substances, including heavy metals, in electrical and electronic equipment (EEE) manufactured, or imported on the market of the European Union, in an effort to protect public health and the environment.

The RoHS Directive requires the maximum tolerable value of 4 kinds of heavy metals used in EEE to be 0.1%:

• Lead
• Mercury
• Cadmium
• Hexavalent chromium

Note that these restrictions also apply to certain types of medical devices and in vitro diagnostic medical devices.

Toy Safety Directive

The Toy Safety Directive establishes migration limit values for 19 kinds of restricted heavy metals:

• Aluminum
• Antimony
• Arsenic
• Barium
• Boron
• Cadmium
• Chromium (III)
• Chromium (VI)
• Cobalt
• Copper
• Lead
• Manganese
• Mercury
• Nickel
• Selenium
• Strontium
• Tin
• Organic tin
• Zinc

All toys or components of toys regulated by this directive should not exceed the migration limits, which are different depending on the heavy metal taken into consideration.

Materials

The Toy Safety Directive differentiates the materials and textures of the toys into three types, and the tolerable limit for each type of the restricted heavy metal differs according to the material type:

a. Dry, brittle, powder-like, or pliable toy material, such as crayons

b. Liquid or sticky toy material, such a finger paint

c. Scraped-off toy material, such as metals, and coatings

Below we report the migration limit for some common heavy metals, while you can find the full table in the text of the Directive.

Element	Dry, brittle, powder-like or pliable toy material	Liquid or sticky toy material	Scraped-off toy material
Chromium (III)	37.5 mg/kg	9.4 mg/kg	460 mg/kg
Chromium (VI)	0.02 mg/kg	0.005 mg/kg	0.2 mg/kg
Lead	13.5 mg/kg	3.4 mg/kg	160 mg/kg
Mercury	7.5 mg/kg	19 mg/kg	94 mg/kg
Nickel	75 mg/kg	18,8	930 mg/kg

Food Contact Materials: Regulation (EC) 1935/2004

The EU Regulation (EC) 1935/2004 is a framework regulation for food contact materials (FCM) in the EU, including packaging, machinery, and kitchenware that are designed to come into contact with foodstuff.

It requires that materials like polymers, adhesives, coatings, varnishing, inks, paints, and others shall not migrate restricted heavy metals over the specified limit values.

Plastic FCM: Regulation 10/2011

Here are some examples of maximum tolerable heavy metal concentration for plastic food contact product:

• Zinc: Not more than 100 mg/kg of plastic
• Copper: Not more than 5 mg/kg of plastic
• Lead: Not more than 2 mg/kg of plastic
• Arsenic: Not more than 1 mg/kg of plastic
• Chromium: Not more than 1 mg/kg of plastic

Ceramics FCM: Directive 2005/31/EC

The directive sets migration limits for different categories of ceramics FCM, including:

Articles with an internal depth of which that does not exceed 25 mm

Lead < 0.8 mg/dm2
Cadmium < 0.7 mg/dm2

All other articles that can be filled

Lead < 4 mg/dm2
Cadmium < 0.3 mg/dm2

Cooking ware; packaging and storage vessels having a capacity of more than three litres

Lead < 1.5 mg/l
Cadmium < 0.1 mg/l

Battery Directive

The Battery Directive in the EU prohibits the sales and distribution of batteries and accumulators containing hazardous substances and establishes rules for the collection, treatment, recycling, and disposal of waste batteries and accumulators in order to improve the environmental and economic performance of batteries and accumulators.

In particular, this Directive prohibits the sales of:

1. Batteries and accumulators that contain more than 0.0005% of mercury

2. Portable batteries or accumulators containing 0.002% of cadmium by weight.

Cosmetics Products: Regulation (EC) 1223/2009

The Regulation (EC) No. 1223/2009 prescribes the maximum permissible value of heavy metals and its compounds in different cosmetic products, including:

• Lead
• Cadmium
• Mercury
• Arsenic
• Antimony

Packaging: Directive 94/62/EC

The Directive 94/62/EC aims to harmonize regulations among the member states in regard to the issue of product packaging and packaging waste. This Directive prioritizes the prevention of packaging waste increases the recycling rate and reduces the final disposal of such waste.

In addition, this Directive also concerns the packaging safety to humans and the environment by limiting the sum of heavy metal concentration levels.

Specifically, the total concentration of lead, cadmium, mercury, and hexavalent chromium in product packaging should not exceed 100 ppm by weight.

Heavy Metal National Regulations

Several member states of the European Union published their own national regulations concerning the issue of heavy metal migration rates on food contact materials. We selected several countries below and briefly introduced some of their specific heavy metal restrictions.

France

The French General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) published several documents regulating the safety of food contact products made from metals, rubbers, plastic glass, ceramic, plant fibers, and several other kinds of organic or inorganic materials.

The document DM/4B/COM/002 set up the heavy metal migration rules for FCMs that are made of inorganic materials such as ceramics, glass, glass-ceramic, and enamel as following:

• Aluminum < 1 mg/kg
• Cobalt < 0.02 mg/kg
• Arsenic < 0.002 mg/kg

Italy

The Decree of the Ministery for Health of March 21, 1973, of Italy oversees the issue of hygiene for packaging, containers, and utensils intended to come into contact with foodstuffs or personal use products.

This Decree regulates the following list of heavy metals elements contained by stainless steel food contact products:

• Chromium
• Cooper
• Nickel
• Titanium

The Netherlands

The Packagings, Paper, and Card Management Decree of the Netherlands requires that the heavy metals content in packaging and packaging components that are made from paper and card, may not exceed 100 ppm by weight. This Decree also regulates packaging for foodstuff and beverages.

These heavy metals stipulated by this Decree include:

• Lead
• Cadmium
• Mercury
• Chromium VI

Belgium

The Belgium Royal Decree of 25th September 2016 establishes a migration limit from varnishes and coatings intended to come into contact with foodstuffs.

The Decree requires the migration limit for 4 categories of food contact materials and they are plastic, ceramics, regenerated cellulose, and active and intelligent materials. The varnish and coatings migration limit of these products shall not exceed 10 mg per decimeter squared.

Spain

The Royal Decree 847/2011 of Spain establishes the positive list of substances allowed for the manufacture of polymeric materials intended to come into contact with food.

This royal decree aligns with the European Resolution AP (89) 1, which regulates the colorants in plastic materials and its heavy metal migration limit as follows:

• Lead: 0.01%
• Mercury: 0.005%
• Cadmium:0.01%
• Chromium :0.1%
• Antimony: 0.05%
• Arsenic: 0.01%
• Barium:0.01%
• Selenium:0.01%

Lab Testing

In order to confirm whether the imported products contain excessive amounts of restricted heavy metals by different legislations for different consumer products, importers can consult a lab testing company such as:

• TÜV SÜD
• Intertek
• SGS
• Eurofins
• ATS

Lab testing costs for heavy metals migration levels usually start at around US$80-100. However, they might vary according to the materials.