• Phthalate Regulations in the European Union: An Overview

    Posted on Leave a comment

    Phthalates are chemicals used to improve the flexibility and durability of certain plastics. Phthalates may also be linked to certain cancers, metabolic disorders, and male infertility.

    It may therefore not come as a surprise that the phthalates are strictly regulated in the European Union – and are the cause of roughly half of plastic product recalls in the EU.

    Still, phthalates can be found in a range of consumer products, including toys, PVC plastic products, nail polish, and food packaging. In this guide, we explain what importers and exporters must know about phthalates restrictions in the European Union.

    What are Phthalates?

    Phthalates are chemicals used to improve the flexibility and durability of certain plastics. There are more than 20 kinds of phthalates.

    Examples

    • DINP
    • DNOP
    • DIDP
    • DEHP
    • DPENP
    • DHEXP
    • DBP
    • BBP
    • DEP
    • DIBP

    Phthalates are mainly used as plasticizers, which are substances that are added to plastics such as PVC to improve product performance, such as flexibility, transparency, and longevity.

    Besides plastic, phthalates can also commonly be found in rubber, coating materials, or adhesives.

    Phthalates can be found in materials used to produce cosmetics, toys, curtains, food packaging, detergents, and medical devices, and in many other products.

    Some scientific researches suggest that exposure to phthalates might interfere with the human’s endocrine system, which might disrupt the normal hormonal level and could lead to various health issues like male fertility decrease, diabetes, breast cancer, obesity, and metabolic disorders.

    Phthalate Regulations in the European Union

    Are Phthalates banned in the European Union?

    The EU restricts several phthalates that are considered dangerous for human health under the REACH Regulation, the Toy Safety and RoHS Directives, the EU Food Contact Materials Framework Regulation, and other regulations.

    According to the RAPEX statistics of 2018, which is the EU rapid alert system for non-food products, DEHP alone accounted for 40% of all chemical recalls for products that contained plastics components.

    Note that the restrictions on phthalates might be of two kinds:

    a. Concentration by weight, for instance, lower than 0.1% by weight

    b. Specific migration limits, especially in food contact materials, for instance, SML 1 mg/kg

    Which products and materials may contain Phthalates?

    Phthalates are used in a large variety of consumer products such as:

    Here some example of specific products that might contain phthalates:

    • Plastic cutlery
    • Plastic wraps
    • Flexible plastic and vinyl toys
    • Jelly rubber toys
    • Paint pigments
    • Nail polishes
    • Moisturizers
    • Medical tubes

    Phthalate Product Regulations Overview

    REACH

    REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is an EU regulation that applies to all consumer products placed in the  EU market.

    The regulation set restrictions on any phthalate that is included in the list of carcinogenic, mutagenic or toxic to reproduction (CMR) substances of category 1A, 1B or 2 under the Classification, Labelling and Packaging (CLP) Regulation, including:

    • BBP
    • DBP
    • DEHP
    • DIBP

    The above phthalates are restricted to a maximum content of 0.1% by weight of the plasticized material in the article (individually or in combination).

    It’s interesting to remark that, before 7 July 2020, such strict limitations used to only apply to toys and childcare products.

    Additional limitations on children products

    For toys and childcare products that might be placed in the mouth, REACH also sets a restriction of 0.1% by weight (individually or in combination) for the following phthalates:

    • DINP
    • DIDP
    • DNOP

    You can learn more about REACH in this guide.

    Cosmetics Products: Regulation (EC) 1223/2009

    The Regulation 1223/2009 on Cosmetic Products covers general safety requirements, assessment procedures, and other requirements for manufacturers and importers of cosmetic products in the EU.

    The regulation bans any substance that is included in the list of CMR substances of category 1A, 1B or 2 under the CLP Regulation, such as the following phthalates:

    • BBP
    • DBP
    • DEHP

    RoHS Directive

    The RoHS Directive restricts the use of certain heavy metals and phthalates that are deemed dangerous, in order to protect the health of the users and avoid environmental pollution.

    Components of electronics products like plastic enclosures, USB cables, power cords, wires, and connectors often contain phthalates as stabilizers.

    The following of phthalates are required to have a concentration lower than 0.1% by weight:

    • PBB
    • PBDE
    • DEHP
    • BBP
    • DBP
    • DIBP

    Toy Safety Directive

    The Toy Safety Directive restricts phthalates that are classified as CMR substances of category 1A, 1B or 2 under the Classification, Labelling and Packaging (CLP) Regulation.

    More specifically, the directive requires that toys intended to be used by children under the age of 14 must contain a concentration lower than 0.1% by weight of the above-mentioned phthalates, which include the following:

    • BBP
    • DBP
    • DEHP

    Note that phthalates are covered by several EN 71 standards, including:

    • EN 71-3: Specification for migration of certain elements
    • EN 71-4: Experimental sets for chemistry and related activities
    • EN 71-5: Chemical toys (sets) other than experimental sets

    If you want to learn what specific standard might apply to your product, or how you can assess the compliance of your toys with phthalates limitations, you can get in touch with a laboratory that offers testing against EN 71 standards.

    Plastic Food Contact Materials: Regulation (EC) 10/2011

    The Regulation (EC)10/2011 covers plastic materials and articles intended to come into contact with food.

    The regulation allows the use of several phthalates that are generally considered dangerous for human health, for some categories of product. For example:

    a. DBP and DEHP are allowed as plasticizers in repeated use food contact materials for non-fatty foods

    b. BBP, DIDP, and DINP are allowed as plasticizers in repeated use food contact materials, and in single-use food contact materials for non-fatty foods, with the exceptions of infant formulae and follow-on formulae

    Here the specific migration limits specified in Annex I of the regulation for the above-mentioned phthalates:

    • DEHP: Migration limit set to a maximum of 1.5 mg/kg
    • DBP: Migration limit set to a maximum of 0.3 mg/kg
    • BBP: Migration limit set to a maximum of 30 mg/kg
    • DAP: Migration limit set to a maximum of 0.01 mg/kg
    • DIDP + DINP: Migration limit set to a maximum of 9 mg/kg

    EN Standards for Children’s FCM

    EN 14372 – Child use and care articles are a non harmonized European Standard that establishes safety requirements and chemical properties for cutlery and feeding utensils intended to be used by children from the age of 6 months to 3 years old.

    It applies to products such as knives, forks, food pushers, plates, and bowls.

    It requires that when thermoplastic components of the regulated products are tested according to the testing methods, the total contact of phthalates shall not exceed 0.1% by weight.

    Denmark Ban on Phthalates

    While Denmark’s Statutory Order on a ban on phthalates in toys and childcare articles mainly follows REACH requirements, the limitations for some kind of phthalates is set to a lower level, that is 0.05% by weight, for the following products:

    • Toys intended to be used by children younger than 3 years
    • Products that are intended to be placed in the mouth, such as a pacifier, by children younger than 3 years

    Phthalate Lab Testing

    In order to ensure that your products do not contain excessive amounts of restricted phthalates and comply with the relevant EU regulations and directives, you shall contact a reliable lab testing company. Consider that costs for a test that determines the content of phthalates in your product start at about US$90-100 per unit.

    Here a shortlist of labs that provide phthalate test services for food contact products, toys, cosmetics and electronics in Europe, Asia, and North America:

    • QIMA
    • Eurofins
    • SGS
    • Intertek
    • ATS

    Manufacturing Risks

    Phthalates content is one of the more common reasons why a product fails lab testing. We have seen a wide range of products, from PVC tarpaulins to PU watch strap, fail third-party testing due to phthalate detection – resulting in the products being rendered non-compliant. We think that this can be partially explained by the fact that not all materials are manufactured specifically for the EU market – but are intended for sales in markets with fewer restrictions concerning phthalates and other substances.

    As such, it’s critical to inform your supplier that all materials used to manufacture your product must be phthalates free.

  • Product Compliance Platform

    Product Compliance Platform: Create Certificates, Label Files & Requirements Lists

    Get Your Account Now

    You can also book a free demo (video call) here


    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

    National/State-Level Standards/Regulations: Many articles don't cover all European national and US state standards, regulations, and requirements. We recommend that you consult a testing company or other professional to confirm all relevant (and current) national/state level standards and regulations.
  • Leave a Reply

    Your email address will not be published. Required fields are marked *