Lead is a well-known toxic substance that poses risks to people’s health and the environment. Levels of exposure can cause long-term damage to people and wildlife. 

Health risks to people

Exposure to lead can happen through food and drinking water, inhalation and maternal blood. It can cause health problems such as cardiovascular diseases, chronic kidney disease, high blood pressure and fertility issues. Lead is especially harmful to children and foetuses as it can interfere with their neurological development. It can also cause adverse pregnancy outcomes, such as low birth weight and even miscarriage. 

In 2010, EFSA published a scientific opinion on the risk for human health related to the presence of lead in food and concluded that the levels of exposure to lead posed a low to negligible health risk for most adults, but there was potential concern over possible neurodevelopmental effects in young children. In 2012 EFSA performed an update of the dietary exposure to lead and found that bread and rolls, tea, tap water, potatoes and potato products were important food categories contributing to dietary exposure of lead in the European population. 

Risks to biodiversity

Lead typically accumulates in the top layer of soils and water, and its use in ammunition and fishing tackle can result in continued presence in the environment. This can have negative effects on wildlife and livestock that come into contact with lead-contaminated sites. 

Harmonised classification and labelling

Lead has the following harmonised classifications in the EU:

Lead massive:

• May cause harm to breastfed children (Lact.)
• May damage fertility. May damage the unborn child. (Repr. 1A)

Lead powder:

• May cause harm to breastfed children (Lact.)
• May damage fertility. May damage the unborn child. (Repr. 1A)
• Very toxic to aquatic life (Aquatic Acute 1)
• Very toxic to aquatic life with long-lasting effects (Aquatic Chronic 1)

Substances of very high concern and REACH authorisation

Lead is included in the Candidate List of substances of very high concern (SVHCs) for authorisation for being toxic to reproduction. 

Producers and importers of articles have to notify ECHA if their article contains a substance on the Candidate List within six months after the substance has been included in the list. This information will be also published in the SCIP database established under the Waste Framework Directive. For this database, the notification obligation applies to all suppliers. 

In April 2023, ECHA recommended adding lead to the Authorisation List (REACH Annex XIV) based on a prioritisation supported by the opinion of the Member State Committee. In the next step, the European Commission and the Member States will discuss the recommendation in relation to other ongoing regulatory activities for lead to ensure that adequate and efficient risk management measures are in place.

If the European Commission decides to include lead in the Authorisation List, after a given date, its use and placing on the market will be prohibited unless the company receives an authorisation from the Commission. 

REACH restrictions

The use of lead in jewellery is restricted. This restriction forbids jewellery articles that contain more than 0.05 % of lead by weight from being placed on the market.

In addition, lead carbonate and sulphates are not allowed to be used or placed on the market in paint, except for the restoration and maintenance of works of art, and historic buildings and their interiors.

Since February 2023, the use of lead gunshot in wetlands has been prohibited across the EU/EEA. In 2021, ECHA proposed an additional restriction on the use of lead in outdoor shooting and fishing. This proposal is currently in the European Commission for decision-making.

Toy safety

The EU’s Toys Safety Directive contains three limit values for how much lead may be found in different types of toy material. The limit for lead in dry toy material is 2 milligrams per kilo. In liquids, the limit is 0.5 milligrams per kilo and in scraped-off toy material 23 milligrams per kilo.

Lead in food

The EU regulation on setting maximum levels for certain contaminants in foodstuffs, sets limits for lead in food. These limits vary from 0.020 mg/kg in milk and infant formulae to 1.5 mg/kg in bivalve molluscs (e.g. oysters, mussels, scallops and clams).

Hazardous substances in electrical and electronic equipment

The EU’s Restriction of Hazardous Substances (RoHS) directive restricts lead and its compounds in all electrical and electronic products. The limit is 0.1%. The limit applies to each homogeneous material in a product rather than a product or a part itself.

However, RoHS includes certain exemptions for specific uses of lead. These include, among others, medical equipment such as magnetic resonance imaging (MRI), and superconductors in cables and wires.

Drinking Water Directive

The current maximum limit for lead in drinking water is 10 μg/l. By January 2036, the limit will decrease to of 5 μg/l. 

Since lead pipes already installed in buildings cannot always be replaced, the limit of 5 μg/l continues to apply as the target for obligations regarding domestic installations. 

For all new materials and substances which come into contact with water intended for people, a total level of 5 μg/l should apply at the draw-off point.