Accessing the Market: European Union Phthalate Regulations
Phthalates are a ubiquitous family of chemicals found in a diverse range of products. Studies now show they can have adverse impacts on human health, leading to the European Union (EU) introducing legislative measures to restrict their use. Manufacturers and suppliers must understand these regulations to remain compliant.
Ortho-phthalates, commonly known as phthalates, are a family of synthetic chemicals with diverse applications in a variety of consumer products. Their ubiquity in our daily lives stems from their usefulness as inexpensive additives. Their primary use is as a plasticizer in polymeric and rubber materials. In addition, they can be used as dispersion agents, enteric coatings, emulsifying agents, gelling agents, solubilizers (solvents), stabilizers or viscosity control agents.
Phthalates are found in a wide variety of materials, including:
- Adhesives and sealants
- Decals and printed designs
- Paints and similar surface coating materials
- Polyurethane (PU)
- Rubber materials
- Soft or flexible polymers or plastics
- Vinyl-based polymers such as polyvinyl acetate (PVA), polyvinyl chloride (PVC) and polyvinylidene chloride (PVDC)
This diversity of use means they are found in a variety of consumer products, including DIY products, medical devices, food contact materials and articles (FCMs), packaging, sports equipment, paints and toys.
Humans can become exposed to phthalates through inhalation, skin-contact or ingestion because they are not chemically bound to their substrate materials and can be released by evaporation or migration. This has created concern that some phthalates threaten human health, and studies have linked phthalates to interference with endocrine (hormone) systems, male fertility matters, obesity and diabetes.
Several phthalates are listed as reprotoxic category 1B substances under EU Regulation (EC) 1272/2008 – Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation). These include:
- Benzyl butyl phthalate (BBP)
- Bis-(2-ethylhexyl) phthalate (or di-(2-ethylhexyl) phthalate, DEHP)
- Bis-(2-methoxyethyl) phthalate
- Dibutyl phthalate (DBP)
- Diisobutyl phthalate (DIBP)
- REACH – Regulation (EC) 1907/2006
- Directive 2008/98/EC ‘Waste’
- Directive 2009/48/EC ‘Toy Safety Directive (TSD)’
- Directive 2011/65/EU ‘RoHS Recast’
- Regulation (EU) 10/2011 ‘Food Contact Plastics’
- Additional Requirements
The EU has restricted six phthalates – BBP, DBP, DEHP, DIDP (di-isodecyl phthalate), DINP (di-isononyl phthalate) and DNOP (di-n-octyl phthalate) – in toys and childcare articles since 1999. Along with other phthalates, these six are regulated under REACH and several other regulations.
Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is a comprehensive piece of legislation for the management of substances. Provisions covering phthalates include:
- Entry 30 in Annex XVII for reprotoxic category 1A or 1B substances (see Table 1)
- Entries 51 and 52 in Annex XVII for BBP, DBP, DEHP, DIBP, DIDP, DINP and DNOP (see Table 1)
- Substances of Very High Concern (SVHCs) on the Candidate List for Authorization
- SVHCs on the Authorization List (Annex XIV)
|Regulated Phthalates under Annex XVII of REACH|
|Entry Number||Substance||Scope||Requirement (unless otherwise stated, provision is currently effective)|
|30||Reprotoxic category 1A or 1B||
||< Specific concentration limit (SCL) or generic concentration limit (GCL) under CLP Regulation|
|51||BBP, DBP, DEHP and DIBP in plasticized materials|
|Use as substances or in mixtures in toys and childcare articles||< 0.1% individually or in combination|
|Placing toys and childcare articles containing BBP, DBP and DEHP on the market||< 0.1% individually or in combination|
|Placing toys and childcare articles containing BBP, DBP, DEHP and DIBP on the market||< 0.1% individually or in combination
(Effective July 7, 2020)
|Placing articles (other than toys and childcare articles) on the market||< 0.1% individually or in combination
(Effective July 7, 2020)
|52||DIDP, DINP and DNOP in plasticized materials|
|Use as substances or in mixtures in toys and childcare articles which can be placed in the mouth||≤ 0.1% (combined)|
|Placing toys and childcare articles which can be placed in the mouth on the market||≤ 0.1% (combined)|
It is important to note that the obligations for SVHCs on the Candidate List and the Authorization List (Annex XIV) are completely different.
Obligations – Candidate List
Article 33 of REACH ‘Duty to Communicate Information on Substances in Articles’:
- Suppliers of an article containing an SVHC in a concentration of more than 0.1% are obliged to provide the recipient of the article with sufficient information to allow the safe use of the article. Minimum requirement is the name of the SVHC
- If requested, the same information must be provided to consumers within 45 days
Article 31(3)(b) of REACH ‘Requirements for Safety Data Sheets (SDS)’:
Suppliers of a mixture that is not classified as hazardous according to the CLP Regulation are obliged to provide an SDS to the recipient on request if the non-gaseous mixture contains at least one SVHC and its concentration is equal to or more than 0.1%.
Article 7 of REACH ‘Notification of Substances in Articles’:
A manufacturer or importer of articles containing an SVHC is obliged to notify the European Chemicals Agency (ECHA) if both of the following conditions are met:
- SVHC is more than 0.1%
- Total quantity of the SVHC in (all) articles is more than one tonne per year per EU manufacturer or EU importer
When an SVHC is added to the Candidate List, manufacturers and suppliers have six months to notify the ECHA.
N.B. Article 3(3) of REACH defines an article as an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition. The threshold limit of 0.1% for an SVHC in an article under Articles 7(2) and 33 of REACH applies to the article as produced. ‘Complex articles’, such as a toy car, a piece of furniture or a ballpoint pen, the limit applies to each component article in the entire article (entire product).
Obligations – Authorization List (Annex XIV)
The use of substances on the Authorization List is prohibited unless the company is exempt or has obtained an authorization from the European Commission (EC). Use must cease by the substance’s ‘sunset date’ – typically 18 months after being listed. If an authorization application has been made at least 18 months before its ‘sunset date’ (latest application date), its use is permitted until a decision on the application has been made. These SVHCs do not apply to articles imported into the EU.
Additional EU Regulations
Directive (EU) 2018/851, amending Directive 2008/98/EC on waste, requires the ECHA to establish a new database to submit information by January 5, 2020. This is for waste treatment operators and, upon request, consumers. The database comprises, inter alia, information submitted by companies that are manufacturing, importing or selling articles containing SVHCs on the Candidate List. Member states are to ensure that suppliers of articles with obligations to communicate SVHCs in articles (Article 33(1) of REACH) are to provide this information from January 5, 2021.
Unless exempted, phthalates and other chemicals that are classified as CMR substances under the CLP Regulation are prohibited in toys (TSD, Annex II, Part III ‘Chemical Properties’).
Amended in 2015, this directive regulates BBP, DBP, DEHP and DIBP in electrical and electronic equipment (EEE). The amendment requires EEE products needing electric currents or electromagnetic fields to fulfill at least one intended function to comply with these four phthalates from July 22, 2019 (Directive (EU) 2015/863). These are in addition to the existing restrictions on lead, cadmium, mercury, chromium (VI), polybrominated biphenyls (PBBs) and polybrominated diphenyl ethers (PBDEs).
- Allows the use of BBP, DBP, DEHP, DIDP and DINP as additives or polymer production aids
- Allows the use of DBP and DEHP as plasticizers in repeated use FCMs for non-fatty foods
- Allows the use of BBP, DIDP and DINP as:
- Plasticizers in repeated use FCMs
- Plasticizers in single-use FCMs for non-fatty foods except infant formulae and follow-on formulae (Directive 2006/141/EC) or processed cereal-based foods and baby foods for infants and young children (Directive 2006/125/EC)
The use of dially phthalate (DAP) is permitted as a starting substance but DIBP is not authorized. These regulated phthalates are subject to requirements for specific migration, total specific migration, and as technical support agents (see Table 2).
|Regulated Phthalates under Regulation (EU) 10/2011|
|Technical Support Agent (unless otherwise stated, in final product)||Specific Migration Limit (mg/kg)|
|1||BBP*||≤ 0.1%||≤ 30 mg/kg|
|2||DBP*||≤ 0.05% (polyolefins in final product)||≤ 0.3 mg/kg|
|3||DEHP*||≤ 0.1%||≤ 1.5 mg/kg|
|4||DIDP*||≤ 0.1%||≤ 9 mg/kg (DINP + DIDP)|
|6||DAP||No restriction||Not detected (≤ 0.01 mg/kg)|
|*≤ 60 mg/kg as part of group restriction number 32 for total specific migration limit|
Manufacturers and suppliers accessing markets in the EU also need to consider specific standards and legislation relating to the Member States. For example, Denmark restricts all phthalates in toys and childcare articles for children up to three years old (Danish Statutory Order 855 of September 5, 2009).
As the adverse effects of phthalates become better understood, restrictions surrounding their use may tighten. Accessing markets in the EU can be difficult; companies need to understand each regulation covering phthalates will impact their particular product.
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