Back in January we reported on the proposed REACH restrictions on PAH in consumer articles. Since then, the European Commission (EC) has revised the proposed text and added a new restriction limit value for toys and childcare articles. The revised text also added “short-term repetitive contact” to the scope for direct contact with the human skin and the oral cavity.
What are PAH?
Polycyclic aromatic hydrocarbons, PAH, are a large group of organic compounds that are composed of two or more rings of carbon and hydrogen atoms. Many of these compounds are carcinogenic, mutagenic, or toxic for reproduction (CMR) and some of them are also persistent, bioaccumulative and toxic for humans and other organisms. They can be generated from industrial processes and everyday activities like burning wood in fireplaces and stoves, smoking tobacco and BBQ. As by-products of incomplete combustion of organic materials, PAH are everywhere around us – in the air we breathe, the water we drink and the food we eat.
Studies have shown that PAH are also present in the plasticised and rubber components of consumer products. Although PAH has no function and therefore not intentionally added in products, its presence often comes from the use of plasticiser oils as softeners to rubbers and plastics or from the pigment carbon black contaminated with PAH. Products that have been found to contain PAH include: plastic bathing shoes, the rubber handle of bicycles, sports items and tools, and car tyres. As PAH are not chemically bound in plastic or rubber materials, they can be released during contact with other materials and their routes of exposure to human include skin absorption, ingestion and inhalation.
Current restrictions on PAH in consumer products and Germany’s proposal
Current restrictions on PAH in consumer products are limited to a small number of products: general CMR requirements in cosmetics and toys under their respective regulations; in chemical products (such as household glues and air fresheners) under REACH Annex XVII; and a specific restriction on extender oils for the production of tyres, also under REACH Annex XVII.
As there is no general restriction on PAH in consumer products, Germany proposed to the EC in June 2010 a general restriction to limit the quantity of PAH present in consumer products. The first proposed regulation was submitted to the World Trade Organisation (WTO) in October 2012 and it has since been revised. The new restrictions will extend the current restriction on the eight PAH in extender oils for tyres to cover also consumer products containing rubber or plastic components that come into direct as well as prolonged or short-term repetitive contact with the human skin or the oral cavity. Products in short and infrequent contact with the skin or oral cavity are outside the restriction scope as the resulting exposure to PAH would be insignificant. A two-year transition period is provided to give stakeholders enough time to make the necessary changes for compliance with these new requirements. Table A shows the details of the revised proposed restrictions.
Table A. Details of the revised proposed restrictions on PAH in consumer products
Polycyclic aromatic hydrocarbons (PAH)
Scope and Limits
Date of Application
Benzo[a]pyrene (BaP) CAS No 50-32-8
Benzo[e]pyrene (BeP) CAS No 192-97-2
Benzo[a]anthracene (BaA) CAS No 56-55-3
Chrysen (CHR) CAS No 218-01-9
Benz[b]fluoranthene (BbFA) CAS No 205-99-2
Benzo[j]fluoranthene (BjFA) CAS No 205-82-3
Benzo[k]fluoranthene (BkFA) CAS No 207-08-9
Dibenzo[a,h]anthracene (DBAhA) CAS No 53-70-3
Consumer articles containing rubber or plastic components that come into direct as well as prolonged or short-term repetitive contact with the human skin or the oral cavity, under normal or reasonably foreseeable conditions of use.
There are two different limits, depending on the product type:
Limit: 1 mg/kg (0.0001%)
Products include (among others):
Sport equipment such as bicycles, golf clubs, racquets;
House-hold utensils, trolleys, walking frames;
Tools for domestic use;
Clothing, footwear, gloves and sportswear;
Watch-straps, wrist-bands, masks, head-bands.
Limit: 0.5 mg/kg (0.00005%)
Toys (including activity toys);
The limits are calculated by weight of the component.
Two years after date of entry into force of the amendment.