Main regulations: Requirements & Constraints

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REACH

Annex XVII

Restrictions are generally used to limit or prohibit the manufacture, the marketing (including import) or the use of a substance. They may also impose relevant conditions, such as technical measures or specific labelling.

A restriction may apply to any substance as itself, to a mixture of substances or to a substance in a product, including those that do not require registration, for example, substances manufactured or imported in quantities under one tonne per year or certain polymers.

SVHCs

Substances with the following hazardous properties can be identified as SVHCs:

• Substances that meet the substance classification criteria as carcinogenic, mutagenic or toxic for reproduction (CMR), Category 1A or 1B according to the CLP Regulation;
• Substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to Annex XIII of the REACH regulation;
• Substances on a case-by-case basis that give rise to an equivalent level of concern as that resulting from the use of CMR or PBT/vPvB substances.

The inclusion in the Candidate List entails immediate requirements for the suppliers of the substance, such as:

• Providing a safety data sheet;
• Communicate information regarding its safe use;
• Respond to consumer inquiries within 45 days;
• Notify ECHA if the products manufactured contain SVHCs in quantities greater than 1 tonne per producer/importer per year and if the substance is present in these products in a concentration greater than 0.1% w/w

ANNEX XIV

ECHA regularly assesses substances on the Candidate List in order to determine which substances should be included as a priority in the Authorisation list. When a SVHC is listed in Annex XIV of the REACH Regulation, the manufacture, marketing and use of the substance is prohibited until a specific authorisation has been issued by ECHA.

Reach allows companies to apply for an authorisation in order to continue or start using or marketing the substances included in the Authorisation list (Annex XIV of REACH).

California Proposition 65 (the Safe Drinking Water and Toxic Enforcement Act of 1986)

Proposition 65 regulates substances known to be carcinogenic and to cause birth defect or other reproductive harm. The substances covered by this regulation are grouped in a list regularly updated by The Office of Environmental Health Hazard Assessment (OEHHA).

It applies to all companies that market their products in the state of California. Companies are required to provide a “clear and reasonable” warning before exposing anyone to a listed chemical, unless the company can demonstrate that the expected level of exposure will not be a significant risk of cancer or reproductive toxicity.

Persistent Organic Pollutants (POP)

Regulation (EC) No. 850/2004 of the European Parliament and of the Council of 29 April 2004 regulates persistent organic pollutants. The objective of this regulation is to set up a regulatory framework to protect human health and the environment by prohibiting, phasing out as soon as possible, or restricting the production, the marketing and the use of POPs. It also defines the rules for the management of stocks and wastes containing POPs.

POPs are classified in lists of substances in the Annex to the Regulation:

• Annex I: List of substances subject to prohibitions;
• Annex II: List of substances subject to restrictions;
• Annex III: List of substances subject to release reduction provisions;
• Annex IV: List of substances subject to waste management provisions.

Food contact

The purpose of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 is to ensure the effective functioning of the internal market in relation to the placing on the market of materials and articles intended to come into contact directly or indirectly with food.

It applies to materials and articles which, in their finished state, are intended to be brought into contact or are already in contact with food or with water intended for human consumption. This does not apply to fixed public or private water supply equipment as well as materials or articles which are supplied as antiques.

Regulation 1935/2004 introduces the inertia principle (Article 3): materials and articles must be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:

• Endanger human health,
• Bring about an unacceptable change in the composition of the food or a deterioration in their organoleptic characteristics.

The Regulation lists the inertia criteria that may apply to a class of materials and will be specified in specific directives or regulations (positive lists of authorised constituents, purity standards applicable to some of these constituents, special conditions of use, specific limits on the migration, overall limit on the migration, provisions against hazards arising from oral contact) as well as sampling and analytical methods.

Groups of materials and articles subjected to specific guidelines are as follows :

Plastics including varnishes and coatings

• Regenerated cellulose
• Elastomers and rubber
• Paper and board
• Ceramics
• Glass
• Metals and alloys
• Wood, including cork
• Textiles
• Paraffin waxes and microcrystalline waxes
• Active materials and articles
• Adhesives
• Cork
• Ion-exchange resins
• Printing ink
• Silicones
• Varnishes and coatings

The Regulation also lays down rules regarding the authorisation of substances in the manufacture of materials, the inspection and control procedures, the labelling of materials and articles, (specific symbol), the written declaration of compliance, traceability and safeguard measures.

Directive 2009/48/EC on the safety of toys

The constant technological developments in the toy market has raised concerns about safety for consumers. In order to take account of these technological developments and to provide regulatory clarification, especially with regards to noise, chemical substances and the risk of choking caused by toys in food, the European Parliament has taken the initiative of reviewing and improving certain aspects of the existing Directive on the safety of toys (Directive 88/378/EEC) and to replace it by Directive 2009/48/EC. It applies to products designed or intended, exclusively or otherwise, to be used for play by children under the age of 14, referred to as “toys”.

Toys, and the chemicals they contain, must not endanger the safety or health of users or third parties when used. They must comply with the applicable community legislation relating to certain categories of products or restrictions on the use of certain substances and mixtures.

Substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A, 1B or 2, in accordance with Regulation (EC) No 1272/2008, must not be used in toys, in components of toys or in micro-structurally distinct parts of toys.

By way of derogation, substances classified as CMR Category 1A, 1B and 2 (Appendix B, section 3 and 4) may be used in toys, in the components of toys or micro-structurally distinct parts of toys provided that one or more conditions are met. Toys shall not contain fragrances and allergenic substances listed. However, their presence is tolerated provided that it is technically unavoidable in good manufacturing practice and does not exceed 100 mg/kg.

SIN LIST

The SIN LIST is a database of chemical substances assessed by the environmental NGO ChemSec as meeting the EU's criteria for Substances of Very High Concern (SVHC) under Article 57 of REACH, regardless of whether they are carcinogenic, mutagenic or toxic for reproduction (CMR), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB) or presenting an equivalent environmental or health threat.

Although not mandatory, the SIN LIST is a practical tool used internationally by companies to identify chemicals before they are classified as SVHCs and placed on the Candidate List.

AAFA RSL

The AAFA-RSL is a list of substances provided to companies in the textile and footwear industry to inform them about substances that are banned or restricted in finished products.

Set up by the American Apparel & Footwear Association (AAFA), an American environmental group, this list supports the textile and footwear industries and their suppliers in establishing a responsible environmental management throughout the supply chain. It also gives them a better understanding of the various national and international regulations governing the quantity of substances allowed in finished products.

Packaging

The heavy metals concentrations in packaging is regulated by Directive 94/62/EC. Member States shall ensure that the sum of the concentration levels of lead, cadmium, mercury and hexavalent chromium present in the packaging or in its components does not exceed a certain threshold.

RoHS (EU, Korea, China, Turkey, Japan…)

RoHS: “Restriction of Hazardous Substances”.

RoHS directives regulate the use of certain substances in electrical and electronic equipment. They are all more or less modelled on the European Directive 2011/65/EU which prohibits the marketing in Europe of any electrical or electronic equipment that contains one of the six substances listed below:

• Lead (Pb): < 1000 ppm
• Mercury (Hg): < 100 ppm
• Cadmium (Cd) : <100 ppm
• Hexavalent chromium: (Cr VI) < 1000 ppm
• Polybrominated biphenyls (PBB): < 1000 ppm
• Polybrominated diphenyl ethers (PBDEs): < 1000 ppm

After a periodic review conducted by the Austrian Umweltbundesamt, the four substances listed below have been added to Annex II of Directive 2011/65/EU:

• Diisobutyl phthalate (DIBP)
• Bis(2-ethylhexyl)phthalate (DEHP)
• Benzyl butyl phthalate (BBP)
• Dibutyl phthalate (DBP)

It should be noted that:

• The limitation of the use of DEHP, BBP and DBP does not apply to toys, which already apply the restriction of use of DEHP, BBP and DBP provided for in section 51 of Annex XVII of Regulation (EC) No 1907/2006.
• The limitation of the use of DEHP, BBP, DBP and DIBP does not apply to cables or spare parts intended for the repair, re-use, updating of functionalities or reinforcement of the capacity of EEE marketed before 22 July 2019, nor to medical devices, including in-vitro medical devices, nor to control and monitoring instruments, including industrial control and monitoring instruments, marketed before 22 July 2021.
• The limitation of the use of DEHP, BBP, DBP and DIBP applies to medical devices, including in-vitro medical devices, and to control and monitoring instruments, including control and monitoring instruments from 22 July 2021.