ANECPosition Paper

Hazardous chemicals in products - The need for enhanced EU regulations

POSITION PAPER

Hazardous chemicals in products

The need for enhanced EU regulations

April 2014

Contact Person: Michela Vuerich

ANEC-PT-2014-CEG-002draft

*1

Raising standards for consumers

ANEC-PT-2014-CEG-002draft – April 2014

ANECPosition Paper

Hazardous chemicals in products - The need for enhanced EU regulations

List of Contents

Executive Summary

1 European policy vision – "A non-toxic environment”

2 Current EU regulatory provisions for chemicals in products

2.1EU regulations for articles

2.2REACH and articles

3 Options for a regulatory framework for chemicals in products

4 Specific regulation needs

4.1Materials in contact with food

4.2Drinking water contact materials

4.3Emissions to indoor air

4.4Clothing and other consumer textiles

4.5Toys

4.6Child use and care articles

4.8Tattoo inks

4.9Nanomaterials (in various products)

4.10Other product areas

Acknowledgements 35

About ANEC

*1

Raising standards for consumers

ANEC-PT-2014-CEG-002draft – April 2014

ANECPosition Paper

Hazardous chemicals in products - The need for enhanced EU regulations

Executive Summary

The present specific European regulatory provisions for chemicals in (consumer) products, particularly in articles, are insufficient. They are either:

  • inadequate because of serious gaps - as in case of food contact materials where only plastics materials are comprehensively regulated; or missing clear limits (medical devices) or lack of a high level of protection (toys), or
  • (almost) non-existent for many products consumers get into contact with, such as materials in contact with drinking water, products releasing emissions to the indoor air, clothing and other consumer textiles, child care articles, packaging, tattoo inks, medical devices, personal protective equipment, furniture, sports equipment, car interiors, …

REACH does not, and will not, compensate for these deficits because articles – particularly imported ones - are barely covered, and the process of restriction is laborious and related to (comprehensive) single substance risk assessments: for example, generic bans of all CMR (carcinogenic, mutagenic or toxic for reproduction) substances in articles cannot be established. An approval system for chemicals in articles - similar to the positive lists in cosmetics and food contact legislation – is not possible. Non-toxic effects or parameters cannot be addressed (e.g. organoleptic parameters, such as smell or taste).

A systematic approach to address chemicals in products relevant for consumers needs to be developed. It should cover overarching principles and basic strategies for all kinds of products, identify priorities, elaborate on product specific requirements (including information provision) as well as monitoring and market surveillance. Consideration shall be given to a horizontal framework to be complemented by product specific implementing measures.

As a matter of highest priority (enhanced) requirements for the following product groups shall be adopted: materials in contact food, materials in contact with drinking water, products releasing emissions to the indoor air, clothing and other consumer textiles, toys, child care articles, packaging, tattoo inks.

Specific provisions for nanomaterials shall be implemented (nano specific product requirements, nano registry).

The need to set (additional) chemical requirements for other product groups such as medical devices, electrical and electronic products, personal protective equipment, furniture or products made from leather or paper needs to be investigated.

1 European policy vision – "A non-toxic environment”

In November 2013 the Council of the EU and the European Parliament agreed on the text of the 7th Environmental Action Programme - the General Union Environment Action Programme to 2020 ‘Living well, within the limits of our planet’[1]. It identifies chemicals in products as an action point: "The Union will also set out a comprehensive approach to minimising adverse effects of hazardous substances, including chemicals in products"(point 50).

It also states that it shall be ensured that by 2020"…risks for the environment and health, in particular in relation to children, associated with the use of hazardous substances, including chemicals in products, are assessed and minimised. Long-term actions with a view to reaching the objective of a non-toxic environment will be identified" (point 54 d).

As we emphasised at the ANEC ASI Consumer Council conference –‘Hazardous chemicals in products, the need for an enhanced EU regulation’[2], ANEC warmly welcomes the commitment of the EU to strengthen its regulatory framework to address chemicals, particularly as regards chemicals in products. ANEC believes that the current provisions at the European level are insufficient and that there is no community approach to address chemicals in products in a systematic manner. A horizontal regulatory approach to address chemicals in products in a systematic way is dramatically needed.

2 Current EU regulatory provisions for chemicals in products

Two studies commissioned by the Consumer Council at the Austrian Standards Institute (ASI)[3] looked into the shortcomings of the current European regulatory framework with respect to chemicals in non-chemical products which are referred to as "articles" in REACH[4]. This includes an analysis of the most relevant EU product regulations as well as an analysis of the requirements related to articles in REACH. The following analysis is based on the studies mentioned above.

2.1EU regulations for articles

A review of the chemical requirements in selected product legislation including:

General Product Safety Directive 2001/95/EC (GPSD)

Personal Protective Equipment Directive 89/686/EEC (PPE)

Toy Safety Directive 2009/48/EC (TSD)

Construction Products Directive 89/106/EEC (CPD)[5]

Restriction of the use of certain Hazardous Substances in electrical and electronic equipment Directive 2002/95/CE (RoHS)[6]

Ecodesign requirements for Energy-related Products Directive 2009/125/EC (ErP)

Gas Appliances Directive 2009/142/EC (GAD)

Pyrotechnic Articles Directive 2007/23/EC

Low Voltage Directive 2006/95/EC (LVD)

Radio and Telecommunications Terminal Equipment Directive 1999/5/EC (R&TTE)

Medical Devices Directive 93/42/EEC

Packaging and Packaging Waste Directive 94/62/EC

Food Contact Materials legislation (various)

Simple Pressure Vessels Directive 2009/105/EC (SPV)

Recreational Craft Directive 94/25/EC

EC-type Approval System for Motor Vehicles (various)

revealed that chemical requirements for (consumer) articles are:

  • missing entirely in several legal texts. For instance, the GPSD contains only a generic requirement that products shall be safe and offers the possibility to adopt only temporary emergency measures, valid for a maximum of 1 year (which were unfortunately rarely taken in case of chemical risks). Other directives without any chemical provisions include the GAS (apart from combustion products and gas leakage), the LVD, R&TTE Directive, the SPV Directive, the Recreational Craft Directive (except for combustion products and leakage of oil and fuel) and the EC-type Approval System for Motor Vehicles (except for combustion products);
  • hardly addressed in the PPE Directive (only a vague provision requiring that materials shall not adversely affect health[7]), the Pyrotechnic Articles Directive (saying that fireworks may only be constructed of materials which minimize risk to health, property, and the environment from debris) and the ErP Directive and related implementing measures (which merely focus on energy efficiency);
  • questionable in the Medical Devices Directive as chemical requirements are dealt with in form of so-called “essential requirements” and are complemented by European standards which contain only risk assessment procedures and no limit values (with the exception of ethylene oxide residues);
  • not sufficiently ambitious in the TSD (e.g. high content of CMR substances allowed and several other categories of dangerous substances not even mentioned), the RoHS Directive (too few substances restricted: lead, mercury, cadmium, chromium VI, PBB and PBDE) and the Packaging and Packaging Waste Directive (only a limit for the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium);
  • incomplete in the Food Contact Materials Legislation (only plastics comprehensively regulated, and even this with significant gaps such as colorants, solvents or printing inks);
  • just referred to as ‘declaration requirements’ linked to regulations in Member States in the CPD/CPR (with the option of not declaring chemicals in case there are no national requirements) and no possibility to establish product requirements (limit values).

From this follows that for many consumer articles (such as clothing, furniture, floor coverings, indoor textiles, personal protective equipment, child use and care articles, sports equipment, construction products, interior of cars, ….) specific chemical requirements are missing. In addition, also nanomaterials are mostly not covered, except for the directive on plastics materials in contact with food which provides that substances in nanoform may only be used if explicitly authorised.

In most cases the scope of the product regulation is restricted to either human health or environment, but not covering both. Moreover, few of these regulations allow for establishing restriction measures for hazardous chemicals or adapting existing ones quickly where the need arises by using a Committee procedure (Comitology) or Delegated Acts. Only the revised RoHS Directive and the Food Contact Materials Legislation allow for adapting the existing chemical requirements. The Toy Safety Directive includes a restricted committee procedure only for certain purposes[8].

Finally, generic phrases in product related legislation such as “producers shall be obliged to place only safe products on the market[9]” or “products must not adversely affect human health” are not sufficient to compensate for the shortcomings identified above. Such legal provisions are indeed often difficult to interpret and comply with for producers/importers, as far as chemicals are concerned at least. In addition, such provisions place a big burden on enforcement authorities, which have to prove that a substance contained or released from a product is posing a risk to consumer health. Hence, often no action is taken[10]. Enforcement cannot be expected to work in absence of clear-cut chemical provisions for products.

With the above, it is obvious that the current European legal framework regarding chemicals in products is insufficient to ensure a high level of safety to consumers and the environment. The ASI Consumer Council study thus concludes that the adoption of a new regulatory framework for chemicals in consumer products is necessary. Generic safety provisions, when already present in product specific legislation, need to be complemented by clear-cut restrictions for substances of concern such as specific limit values in order to ensure a high level of safety for consumers and benefit manufacturers and enforcement authorities.

2.2REACH and articles

Despite claims to the contrary, REACH does not and cannot compensate for these deficits for a number of reasons. REACH primarily addresses the manufacturing and use of chemical substances and mixtures (in Europe) and hardly covers chemicals in (consumer) articles, particularly in imported articles. The main article related deficits of REACH are:

  • Registration of substances in articles is required only if the substance is present in those articles in quantities above 1 tonne per year and if the substance is intended to be released (e.g. a scented product which is rather exceptional).
  • Just a notification of the use of a Substance of Very High Concern (SVHC)[11] is required if the substance is present in those articles in quantities exceeding 1 tonne per year and if the substance is present in those products above a concentration of 0,1 % weight by weight (w/w), unless the manufacturer or importer can exclude exposure to humans or the environment. It should be noted that a substance complying with the SVHS criteria (e.g. CMR category 1A and 1B) is not per se a SVHC. It becomes a SVHC only if the substance has been identified as such and has been included in the candidate list. Hence, this provision covers just a limited number of substances, is difficult to enforce and, in particular, does not exclude the presence of SVHCs in articles.
  • Neither registration nor authorisation leads to chemical limits in products. Only the restriction path of REACH can establish such requirements. However, the restriction path which requires a so-called Annex XV dossier is laborious and time consuming. It does not come as a surprise that very few restrictions have been adopted since REACH was adopted in December 2006. At that time the Annex XVII included 50 entries. By end of 2013 the number increased to 63 entries. Even though some additional restrictions were incorporated by modifying existing entries the progress was rather modest to say the least. This is in stark contrast to the pragmatic approach to regulate chemicals employed in other areas (e.g. chemical requirements in other EU legislation or at the MS level).
  • REACH restrictions are generally based on single substance risk assessments. From this follows that generic bans of substances falling in a certain hazard class (e.g. all CMR substances) in articles are not possible. This is a severe limitation bearing in mind that such generic bans allowing to exclude a huge number of substances have been used in certain EU product regulations for good reasons (e.g. Cosmetics Regulation, Toy Safety Directive). A possible exception is given by Article 68(2) for CMR substances category 1A and 1B (including in articles) which could be used by consumers where the Commission may use a streamlined procedure without Annex XV dossier. Whether this means that a generic CMR ban in certain articles may be imposed is an open question (the paragraph refers to "a substance"). But in any case it is obvious that this option is restricted to 1A and 1B CMRs whilst the CMR ban in the legislation for cosmetics and toys includes also category 2 substances. Hence, its usefulness for consumer protection is rather limited.
  • REACH does not allow using an approval system for chemicals in articles. However, positive lists as used in cosmetics and food contact legislation are preferable from a consumer protection perspective even if it may take a long time to establish them. It is inherent to such systems that non-approved substances are not allowed. Hence, the positive list system reverses the burden of proof – only substances which have been shown to be safe can be used. In addition, the positive list system typically relies on approval by a scientific industry independent assessment. It is the preferred choice whenever a very high level of safety is needed (as in case of material in contact with food or drinking water).
  • Non-toxic effects or parameters cannot be addressed in REACH. However, these parameters have been used to establish chemical requirements in various articles. This includes, for example, organoleptic parameters (smell, taste) or sum parameters used to assess indoor air quality (TVOC, SVOC) or sweat/saliva resistance or overall migration limits used to limit the release of substances from materials.
  • REACH addresses intentionally added substances and their impurities but does not address reaction products formed in the processing of materials. This includes, for instance, N-nitrosamines formed during the vulcanisation process of rubber for which limits have been established (e.g. for soothers).
  • REACH information requirements are insufficient, particularly as regards information on chemicals in consumer articles. REACH Article 33 just provides an obligation for a supplier of an article to provide a consumer "on request" with "sufficient information" including the name of the substance in case an article contains a SVHS above 0,1 %. This is far from a desirable requirement calling for a comprehensive chemicals declaration to be provided to the public (without request).

There are further significant limitations of REACH which are not specific for articles. For instance, the data requirements in REACH depend primarily on the production or import volume of a substance and only to a limited extent on the hazardousness of the substance. Registration of substances also mainly relies on industry self-assessment. Only a small fraction of registration dossiers will be (independently) evaluated by ECHA and the Member States.

Moreover, the implementation period of the REACH Regulation is extremely long. It will, for instance, take a long time before every substance meeting the criteria of SVHC will be subject to proper independent assessment via the authorisation route. It is acknowledged that the adopted SVHC roadmap aims to include in the candidate list all "relevant" SVHCs by the end of 2020. However, it remains to be seen whether this can be accomplished given the current procedural and resource constraints. But even if so, this is still a very, very long way to go and would still not exclude identified substances meeting the SVHC criteria from imported articles.

There are no specific requirements on nanomaterials in REACH (for further details see below under 4.9).

The REACH provisions can thus not ensure elimination of dangerous chemicals from consumer products and cannot compensate for deficits in product regulation. Hence, it is necessary to develop a new approach to address chemicals in products.

3 Options for a regulatory framework for chemicals in products

There are various possibilities for strengthening the regulatory framework for chemicals in consumer products including the following options:

  1. Expand/revise existing product directives to (adequately) cover chemicals in all relevant consumer products
  2. Introduce new sector specific chemical legislation following the RoHS model
  3. Extend REACH to address chemicals in (consumer) products in a comprehensive way
  4. Adopt a horizontal framework directive for chemicals in products to be complemented by sector specific rules
  5. Extend the scope of the ErP Directive to cover also non-energy related products and to include generic and specific chemical restrictions in principle for all kinds of products

The first two options would necessitate the adoption of quite a few pieces of legislation for different product categories, or amendments to existing legislation. This would not only be time-consuming and burdensome but would also not facilitate the application of a horizontal approach.

The third option which is to revise the REACH Regulation in order to integrate more stringent provisions for chemicals in consumer products seems unrealistic. REACH is indeed already a very complex legislation, and the European Chemicals Agency ECHA is overburdened with administering the system. It may be even a better option to eliminate all product related elements from REACH and to use it for the manufacturing and using of chemicals only. The restriction path of REACH could be shifted to a new framework for addressing chemicals in products/articles.

The fourth option, i.e. the adoption of a horizontal directive for chemicals in products, may be useful but its adoption would possibly face some opposition and take many years before making its way out. On the other hand, it is appealing to think of a horizontal regulatory framework for products focusing on chemicals only.