The substitution principle in REACH and other legislation

Compared to the previous legislative framework, REACH introduces a (under certain conditions) compulsory substitution principle based on the hazardous properties of a substance in addition to the already previously established risk-based restriction measures. The authorisation title of REACH specifies in Article 55:

“The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution”

Substances of very high concern (SVHC) are chemicals with very serious and possibly irreversible effects on human health or the environment. REACH foresees the inclusion of identified SVHC in Annex XIV REACH, the so called Authorisation list, obliging companies to apply for an authorisation to use an SVHC. Thus, (pure) hazard criteria are considered in regulatory decision making. These cut-off or exclusion and substitution criteria are applied independently of standard risk assessments and aims to restrict the use or phasing out of substances with very severe intrinsic properties which may pose an unacceptable risk to human health or the environment. Less emphasis is given to assess whether the substance actually presents a risk or if efforts can be done to reduce the exposure and thereby minimising risk arising from the use of such a substance.

Legislation and international agreements relevant to substitution either refer directly to the substitution principle or are closely related to it. Before REACH entered into force, the substitution principle was already directly included in the EU occupational health and safety legislation, rather as a general requirement than permits and strict conditions. The Chemical Agents Directive 98/24/EC lays down minimum requirements for the protection of the health and safety of workers and defines substitution of hazardous chemicals by less hazardous chemicals or processes as first priority (Article 6). The Carcinogens and Mutagens Directive 2004/37/EC aims to protect workers from risks related to carcinogens and mutagens, and requests that employers reduce them at the work place, in particular by replacing them, as far as technically possible (Article 4(1)).

Besides REACH, the substitution principle has also been introduced in the revision of the pesticides legislation, the Biocidal Product Regulation (BPR, Regulation (EU) 528/2012) and the Plant Protection Products Regulation (PPR, Regulation (EC) 1107/2009). Biocidal substances are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria. The new biocidal products regulation entered into force in September 2013 and introduces exclusion and substitution criteria for “substances of concern”. Active substances meeting the exclusion criteria should not be approved (Article 5 BPR). These include CMR substances (CLP classification in category 1A or 1B), endocrine disruptors that may cause adverse effects in humans or identified as SVHC according to Article 57(f) REACH, and PBT or vPvB substances (fulfilling criteria of Annex XIII REACH). Similarly, the Regulation on plant protection products (PPR), which entered into force in 2011, defines approval criteria (Annex II, 3.6-8). No approval should be given to active substances, safeners or synergists that are CMR (CLP category 1A or 1B) or to endocrine disrupters which may cause adverse effects in humans.

Besides REACH, there is product and life-cycle stage specific legislation. The RoHS Directive 2011/65/EU restricts the use of certain hazardous substances in electrical and electronic equipment. Regarding substitution it states that “[…] taking into account technical and economic feasibility, including for small and medium sized enterprises (SMEs), the most effective way of ensuring a significant reduction of risks to health and the environment […] is the substitution of those substances in EEE [electrical and electronic equipment] by safe or safer materials […].” Also the Batteries and Accumulators Directive 2006/66/EC has the goal of minimising the negative impact to the environment and restricting certain hazardous substances and Member States are encouraged to promote the use of less polluting and hazardous substances, in particular for substituting cadmium, mercury and lead. Similarly, the End-of-life-vehicles Directive 2000/53/EC restricts the use of certain hazardous substances in vehicles, which can be achieved by substitution.

The chemicals legislation is linked to occupational health, consumer and product/ sector-specific pieces of legislation (Directive on general product safety, RoHS Directive, Cosmetics Regulation, etc.), and also to major pieces of environmental legislation: Water Framework Directive, Volatile Organic Compounds (VOC) Directive, Solvents Directive, Industrial Emissions Directive, Ozone Layer Regulation, etc. Thus, there are further Community legislation and international agreements on substitution of hazardous substances with specific properties, e.g.: Regulation (EC) 850/2004 transfers the Stockholm convention on Persistent Organic Pollutants and the Long-Range pollution Protocol into EU law and implements strict measures for the elimination of the production, placing on the market and use of Persistent Organic Pollutants (POPs). The VOC Solvents Directive 1999/13/EC reduces emissions of Volatile Organic Compounds to the atmosphere and applies to a certain list of activities. Article 6 and 7 refer to substitution and especially CMR compounds should be replaced.