EU Enacts Additional Phthalate Restrictions
The European Union has finalized an expansion of phthalate restrictions under REACH, with most new restrictions to be phased in effective July 7, 2020. Diisobutyl phthalate (DIBP) will be restricted in the plasticized material in all articles unless an exemption applies. Existing restrictions on three other phthalates – bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP) – which currently only apply to plasticized material in toy and childcare articles will be expanded in scope to plasticized materials in all articles unless an exemption applies. This action is separate from restrictions on the use of these four phthalates in electronics under the EU Restriction of Hazardous Substances (RoHS) Directive (which take effect in July 2019) and the expansion of phthalate restrictions in toys and childcare articles by the U.S. Consumer Product Safety Commission.
Background – REACH and RoHS Phthalate Restrictions
Entries 51 and 52 of REACH Annex XVII restrict six phthalates – DEHP, DBP, BBP, di-isononyl phthalate (DINP), di-isodecyl phthalate (DIDP), and di-n-octyl phthalate (DNOP) – in toys and childcare articles. Entry 51 restricts DEHP, DBP, and BBP to 0.1% by weight in plasticized materials in toys and childcare articles. Entry 52 restricts the use of DINP, DIDP, and DNOP to 0.1% by weight in plasticized materials in toys and childcare articles which can be placed in the mouth by children.
The EU RoHS Directive, which applies to most electrical and electronic equipment placed on the market in the EU, also contains restrictions (not yet in effect) on the same four phthalates. These pending restrictions will be phased in starting July 22, 2019. The four phthalates will be restricted to 0.1% by weight in homogeneous materials of in-scope equipment.
New REACH Restrictions
Entry 51 of REACH Annex XVII will be expanded to add an additional phthalate and will apply to a broader scope of articles (Entry 52 will not change). Under Paragraphs 1 and 2 of the reworked Entry 51, the cumulative use of DEHP, DBP, BBP, and DIBP will be restricted to 0.1% by weight in the plasticized material of toys and childcare articles. Paragraph 1 applies to phthalates used as substances or in mixtures and goes into effect this month. Paragraph 2 applies to a broader category of uses in toys and childcare articles and its new restrictions will go into effect on July 7, 2020.
Under new Paragraphs 3 and 4, the cumulative use of the same four phthalates will be restricted to 0.1% by weight in the plasticized material of all articles, unless an exemption applies. These restrictions will go into effect on July 7, 2020. Available exemptions to Paragraphs 3 and 4 include:
- Electrical and electronic equipment in the scope of the RoHS Directive.
- Articles exclusively for industrial or agricultural use, or for certain articles exclusively for outdoor use.
- Certain articles related to aviation or motor vehicles.
- Measuring devices for laboratory use.
- Certain food contact materials.
- Certain medical devices and packaging of medicinal products.
- Articles placed on the market before July 7, 2020.
Entry 51 also now clarifies that the term “plasticized material” means any of the following homogeneous materials:
- Polyvinyl chloride (PVC), polyvinylidine chloride (PVDC), polyvinyl acetate (PVA), and polyurethanes.
- Any other polymer (e.g., polymer foams and rubber material) except silicone rubber and natural latex coatings.
- Surface coatings, non-slip coatings, finishes, decals, and printed designs.
- Adhesives, sealants, paints, and inks.
Effects on the Electronics Industry
Electronics in the scope of the RoHS Directive will not be affected by the REACH amendment. However, the REACH amendment will apply to electronics that are out of the scope of the RoHS Directive, including certain finished electronics (e.g., large-scale stationary industrial tools, large-scale fixed installations, certain photovoltaic panels, and certain equipment designed solely for research and development), as well as certain electronic components. Manufacturers and importers of such products and components should ensure that the new REACH phthalate thresholds are met by July 7, 2020. They should also note that the pending REACH restrictions are more stringent than the pending RoHS Directive restrictions on the same four phthalates. The pending RoHS Directive restrictions apply the 0.1% threshold to each phthalate, while the pending REACH restrictions apply the 0.1% threshold cumulatively to the four phthalates.
Beveridge & Diamond assists clients with regulatory requirements under a wide variety of statutes as they relate to consumer products. We counsel clients on the growing number of chemical-specific requirements that affect consumer products. For more information on issues related to chemicals in products, please contact the authors or any member of our Consumer Products Practice.