Where are the SVHCs?
10 years consumer’s ‘right to know’ about substances of very high concern
Environmental Sciences Europe volume 29, Article number: 24 (2017)
The European chemicals regulation REACH includes the legal duty for suppliers to inform consumers on request about the presence of substances of very high concern (SVHCs) in articles. Since this requirement has been in force now for 10 years, the intention of this study was to find out whether information on SVHCs is adequately communicated to the consumer today. Data on the presence of SVHCs in articles were collected as a prerequisite for the subsequent requests for a targeted choice of articles to examine the operability of the ‘right to know.’
Literature data show that SVHCs have been measured and described in a large variety of commodities. 32% of 334 information requests for articles which were suspected to contain SVHCs were answered by suppliers and a minor number of these answers were of good quality. Only two respondents indicated the presence of SVHCs in their articles. Suppliers are not legally obliged to respond to requests if their articles are free of SVHCs. Therefore, the absence of a response might be interpreted as an indication that SVHCs are present below 0.1% in the articles in question. However, there are certain doubts that only two out of 334 articles suspected contain SVHCs.
The data question whether the ambitious aims of the SVHC regime can be achieved under the present conditions. Measures are proposed on how to improve implementation of the information requirement and to amend the legal criteria in the upcoming REACH revision.
The European chemicals regulation REACH 1907/2006/EC  introduced a new communication duty concerning substances of very high concern (SVHCs) in articles (Art. 33). SVHCs are chemicals which are carcinogenic, mutagenic, toxic for reproduction, or very critical for the environment because they are persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) or which cause concern for other reasons such as endocrine disruptors ( Art. 57). They are listed in the so-called candidate list  which is updated twice a year (last update 12/01/2017 with a total of 173 entries) and which should include all relevant currently known SVHCs by 2020 . According to Art. 33(2), consumers have the right to receive information from the suppliers of an article who is “any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market” [1 Art. 3 (33)] about the presence of any SVHC. This applies for SVHCs that exceed a threshold of 0.1% (weight/weight) in an article in terms of REACH, in a subassembly of an article [4, 5] or in its packaging. Information shall be provided within a time period of 45 days upon receipt free of charge. This information obligation is a very important element in the REACH regulation with the ambitious goal to minimize adverse effects for the consumer and the environment by increasing transparency and awareness on SVHCs in consumer articles, by helping the interested consumers to make informed purchasing decisions and by ensuring a safe use of articles, and it supports the efforts by producers to substitute SVHCs by less dangerous chemicals.
The threshold of 0.1% (weight/weight) is based on a pragmatic decision like many other thresholds in legislation. A concentration limit was preferred to the limitation of release rates, which would have been much more difficult to estimate and which would depend on many article-specific parameters. Articles that contain more than 0.1% SVHCs do not necessarily lead to an exposure of consumers. This might only be the case if consumers get in direct contact with such an article, and if the SVHC has the potential to migrate out of the material. However, at the end of their product lives, articles containing SVHCs can contribute to an increased exposure of SVHCs in the environment depending on the waste disposal method leading potentially to an indirect exposure.
Some organizations published sample letters or online forms to support consumers with their requests (e.g., ). The German Federal Environment Agency has recently published a smartphone application ‘Scan4Chem’  which facilitates the information request further. The smartphone application ToxFox by Friends of the Earth Germany included the question about SVHCs in their tool in addition to endocrine substances in 2016 .
Suppliers are not able to inform consumers about SVHCs if they do not receive the necessary information from the upstream users. Therefore, the implementation of the information duty according to Art. 33(2) depends crucially on an efficient information transfer in the supply chain as required in Art. 33(1) [9, 10]. The SVHC provisions in REACH motivate innovations. Several companies increased their efforts and substitute SVHCs in their articles. They prefer suppliers who renounce SVHCs, and several retailers demand supply of ‘SVHC-free’ articles. There are companies that manage to eliminate the use of SVHCs in all their articles. Some companies started cooperation with non-governmental organizations to make their products safer. These companies know more about their articles and the materials they are made of. They are better prepared for upcoming authorizations and restrictions and hence save future expenses and efforts. The promotion of these endeavors in the public raises the company’s reputation and contributes to a more trustful relationship with consumers. Therefore, phasing out SVHCs will result in competitive advantages for these companies [11, 12].
Various guidance documents exist which support suppliers to fulfill the information duty toward consumers [13,14,15]. They also receive online help [2, 16, 17] or can attend workshops at national or international level [11, 18].
What is the quality of the answers received from suppliers? Is the information that customers receive on their SVHC request helpful for them? Previous studies had shown many obstacles in the implementation of Art. 33(2) in practice [12, 19,20,21]. The objectives of this study were to analyze the functioning of this risk communication duty and to make recommendations for a potential revision of REACH provisions, e.g., in the upcoming REACH review of the scope of Art. 33 by 2019 [1 Art. 138 (8)]. As the online tool offered by the German Federal Environment Agency was used for the requests made in this study, also the performance of this tool was evaluated.
The first step of this investigation consisted of a compilation of data on the potential or verified presence of SVHCs in consumer articles, which allowed in the second step to make targeted information requests for such concrete articles in the retail market. The answers to the information requests were compared with the results of other studies and examined in the light of the knowledge about the amounts and frequency of these substances as described in the first step.
Data on the presence of SVHCs in articles were searched in the literature considering national surveillance programs, non-governmental organization activities, research studies, and publications by the European Chemicals Bureau.
In the second step, 513 consumer articles were selected from the retail market in the area of Ulm and Stuttgart between August 29 and October 24, 2016. Article groups were preferred which had a certain probability to contain SVHCs as found out in step one. Many articles sold by well-known, large, and/or multinational companies were considered, because their quantitative impact on the total amount of SVHCs present in consumer articles might be large and their share of the supply offered to consumers will be larger compared to small companies. The barcode numbers printed on the labels of the articles were entered into the online tool offered by the German Federal Environment Agency . Currently, the online tool is being reprogrammed and therefore not available. The smartphone app Scan4Chem  may be used instead. No requests were made by other means, such as by written letters via postal mail, by fax, by phone, or by direct face-to-face communication at the retailer of the articles. Requests were made preferentially for several articles of the same article category originating from different brands. This mimics the situation of a consumer who wants to buy a certain article without SVHCs and who does not want to wait again up to 45 days if the first article response declared the presence of SVHCs. Interested consumers would make several simultaneous information requests for comparable articles. The answers received by the suppliers or distributors were collected and analyzed and compared to results by previous studies.
Results and discussion
SVHCs in articles
The following sections assess which SVHCs, depending on their functions and chemical characteristics, are likely to be found in certain article categories and not in others. This allowed to select article categories presumed to contain SVHCs for the next tier of the investigation where information requests were sent to the article suppliers.
Table 1 shows a selection of SVHCs with examples of their potential presence in consumer articles. Data from the registration dossiers  indicate the annual amounts produced or imported into the European Union (Table 1, right column). It is important to note that most SVHCs are not only used in consumer articles, but also in other applications. Hence, only a fraction of these amounts is actually present in consumer articles. Manufacturers who use more than one ton SVHCs per year in articles (content exceeding 0.1%) must submit a notification of this use to ECHA (Table 1, column 1), unless exposure of humans or the environment can be excluded or unless the use is covered in the registration dossier for the substance [1 Art. 7 (2)]. Therefore, all notified substances in Table 1 are or will be used in applications with a certain exposure. Data in Table 1 are based on data provided by producers and importers in the REACH process for the European Union . Up to October 2016, there were only 365 notifications for 39 candidate substances in articles , which is below the expected number of notifications. The question is whether other uses have been terminated and are no longer relevant, whether many notifications must still be expected, or whether other usages are covered in the registration dossiers. The low figure of notifications according to REACH Art. 7 ‘is likely to illustrate a low level of compliance’ .
While Table 1 column 2 contains the potential presence of the respective SVHCs in consumer articles, the following paragraph compiles information on the article-specific occurrence of SVHCs, such as governmental or non-governmental surveillance data, substance estimations in articles, or guidelines for environmentally friendly products.
Surveillance programs were initiated to control the presence of substances prohibited in articles  and to enforce the SVHC provisions relating to articles. Some data on these activities are published in the annual reports of the responsible national authorities. It must be emphasized that the surveillance programs by national as well as by non-governmental programs focus on about a dozen SVHCs, whereas the number of SVHCs amounts to currently 173. The small number of substances monitored is due to various reasons, such as the practicability of the analytical methods, the costs of expensive articles, the handling of very bulky or heavy articles, or the fact that some SVHCs undergo chemical reactions in the production process and might then stay below the trigger value in the final article. Furthermore, the surveillance of the same substances over several years allows to detect trends. The surveillance programs conducted by the enforcement authority of the German Federal State Baden-Württemberg focused on a few article groups where SVHCs or restricted substances [1 Annex XVII] might be expected. In 2013, the analytical measurements conducted in their surveillance programs revealed that SVHCs and restricted chemicals were present in many consumer articles, in some cases at rather high concentrations. Two-thirds of the articles under scrutiny contained SVHCs above the threshold of 0.1% and many answers by suppliers were wrong. 22 out of 84 articles contained more than 0.1% of the respective phthalates DEHP (up to 19%) and DIBP, whereas the producers had not indicated these SVHCs in their Art. 33(2) answers. The authorities analyzed up to 15 different phthalates, some of which are SVHCs (di-iso-heptyl phthalate (DIHP), bis-(2-methoxyethyl)phthalate (BMEP), N-pentyl-isopentylphthalate (PIPP), dipentyl phthalate (DPP), diisopentylphthalate (DIPP), dihexylphthalate (DHP)), some are SVHCs and listed in Annex XVII  (dibutyl phthalate (DBP), bis-(2-ethylhexyl)phthalate (DEHP), benzylbutylphthalate (BBP), di-iso-butylphthalate (DIBP)), and some of them are listed in Annex XVII and are no SVHCs up to now (dioctyl phthalate (DnOP), di-iso-nonylphthalate (DINP), di-iso-decylphthalate (DIDP)). Some phthalates that had previously been used as substitutes have meanwhile been regulated. This example of phthalates shows the problem, which surveillance organizations as well as producers have to face when provisions for a certain substance might change in the course of the years as the candidate list, Annex XVII, or other regulations are updated. Persistent organic pollutants such as short-chain chlorinated paraffins and HBCDD were also detected in various articles by the surveillance authorities of Baden-Württemberg. Cadmium was measured in articles with PVC material, jewelry, hard solder, and packaging. The biocide DMF was found in shoes and other leather articles. Lead (up to a concentration of 62%) and cadmium (up to a concentration of 0.18%) were measured in certain parts of electronic equipment. According to the data available in the annual reports between 2010 and 2014 [12, 26], the number of complaints remained at the same level during these years.
In 2011, the Environment Agency Austria tested phthalates and found di-iso-butylphthalate (DIBP) (36% w/w in plastic mats for children), di-iso-nonylphthalate (DINP)(43% w/w in massage balls), and di(ethylhexyl)terephthalate (up to 10% in inflatable outdoor children pool products) .
In 2016, the Swedish Chemicals Agency examined the presence of lead, cadmium, certain phthalates, short-chain chlorinated paraffins, and brominated flame retardants in a random check of 154 electrical and electronic articles. They detected prohibited substances in 38% of the articles which had to be withdrawn from the stores. Furthermore, six articles contained SVHCs above 0.1% .
In 2010, the Nordic council estimated in comprehensive case studies in cooperation with producers the realistic presence of SVHCs in the following articles: an upholstered sofa might contain hexabromocyclododecane (HBCDD) (5–10% w/w), formaldehyde, phthalates (DEHP, DBP, and BBP), chromium, azodyes, pigments, and organo-tin compounds (TBTO). A sports shoe might contain azodyes, dispersive dyes, formaldehyde in the textile parts, chromium VI, PCP, short-chain chlorinated paraffins in the leather parts, cadmium, lead, dimethylformamide, aromatic solvents, DEHP, DBP, and BBP in the plastic parts. A pliers might contain DEHP, DBP, and anthracene in the handles and chromium VI in the metal parts. A power distribution unit might contain DEHP in the PVC wire coatings and brominated flame retardants. A desktop computer might contain DBP (15% w/w in flexible PVC), DEHP (30–45% w/w in flexible PVC), BBP (30–45% w/w in flexible PVC), HBCDD (5–7% w/w in polystyrenes), short-chain chlorinated paraffins, and TBTO .
A group of European competent authorities provided practical advice for suppliers on the SVHC information duty and described the potential SVHC content of a selection of exemplary articles . The following articles were identified which could contain SVHCs above the trigger value of 0.1%. A red plastic garden chair contained lead chromate molybdate sulfate red (C.I. Pigment Red 104). The handlebar grips of a bicycle contained DEHP and the seat covering contained dibutyl phthalate (DBP). A sofa covering consisting of textile contained HBCDD and the polyurethane cushion contained 0.2% tris(2-chloroethyl)phosphate. The PVC coating of a cable contained benzylbutylphthalate (BBP). A T-shirt with a print contained DEHP. A printed circuit board contained dibutyl phthalate (DBP), capacitors contained dibutyl phthalate (DBP), and a frying pan contained PFOA .
Substances of very high concern and restricted chemicals in articles were also monitored by non-governmental organizations. Azodyes, 3,3′-dimethoxybenzidine, 4-aminobenzidine, p-cresidine, and allergenic and carcinogenic dyes were detected in textiles [30, 31]. Heavy metals such as chromium III, chromium VI, tin, cadmium, nickel, lead, and antimony were measured in textiles [30, 31]. HBCDD was detected in textiles  and in packaging . TBTO and various fluorinated compounds were found in textiles . Phthalates were found in textiles [30, 31] and in various plastic articles . PAHs were detected in textiles  and in children’s rubber boots . Nonylphenol was detected in textiles .
Turnbull described the presence of short-chain chlorinated paraffins, HBCDD, TBTO, DBP (15%), DEHP, and BBP (total phthalate content 30–45%) in electronic equipment .
Criteria of voluntary product eco-labels such as the European eco-label , the German Blue Angel , or the Nordic Swan  often include requirements for hazardous substances. Most basic criteria for eco-labels for articles in terms of REACH comprise restrictions of SVHCs. The European eco-label is very strict and may not be awarded to SVHC-containing goods [34 Art. 6(6)]. Other eco-label criteria are a rich source for article types which might contain SVHCs (above or below the 0.1% trigger limit), unless they fulfill the ambitious eco-label standards. Just to name but a few examples of basic criteria in the German Blue Angel regime for articles: the criteria RAL-UZ 120 for resilient floor coverings rule out SVHCs as plasticizers or flame retardants, RAL-UZ 132 for thermal insulation material exclude phthalates and halogenated organic flame retardants, RAL-UZ 171 for office equipment with printing function exclude the intentional addition of SVHCs in various materials, or RAL-UZ 119 for mattresses contain regulations on tin-organic substances (such as TBTO), fluorinated hydrocarbons (such as PFCs), and other halogenated organic compounds like flame retardants.
The ‘Oeko-tex standard’ is a private certification system for textiles. Products that fulfill its criteria are marked by the ‘Oeko-tex standard’ label . These criteria include also the analytical determination of harmful chemicals which may not surpass certain concentration thresholds in the specific fabric. Some of the substances which Oeko-tex monitor are SVHCs, such as dyestuffs and pigments classified as allergenic, carcinogenic, or banned for other reasons (two azodyes are SVHCs), extractable heavy metals (various lead and cadmium compounds are SVHCs), flame retardant substances (such as HBCDD), organic tin compounds (such as TBTO), perfluorinated compounds, phthalates (such as DEHP, DBP, BBP), polycyclic aromatic hydrocarbons (PAH) (such as anthracene), nonylphenol, OP, OPEO, and NPEO (which are also SVHCs). These criteria indicate which SVHCs might be present in textiles above or below the 0.1% trigger value.
Some SVHCs, such as plasticizers, are usually present in high percentages in materials, so that many articles containing phthalates fall under the information duty. On the other hand, other SVHCs are present far below 0.1% in an article, and their presence does not need to be communicated although their applications are very critical under environmental aspects. This is, for example, the case for perfluorinated compounds which are used in textile finishing and have a very long half-life.
Compliance after 10 years ‘right to know’
The REACH information right for consumers about candidate list substances has been in force now for nearly 10 years and several studies have revealed since, that a large number of suppliers do not fulfill their obligations as foreseen. The data presented show that some companies take their responsibility for a trustful communication with the consumer seriously and have a very ambitious management system for minimizing dangerous substances in their production chains. On the other hand, the quality of answers received by the majority of suppliers is still insufficient. This indicates that the situation has apparently not improved satisfactorily. The aims of the REACH ‘right to know’ are ambitious, but apparently many suppliers are not aware of their communication duty and the concomitant advantages for them. There are also some doubts whether all suppliers’ answers are correct. The number of respondents who announce that their articles contain more than 0.1% of an SVHC is extremely low considering the targeted choice of articles in the present study, while publicly available data indicate that a lot of consumer articles today still contain SVHCs above the threshold of 0.1%. Without chemical analysis, it is not possible to decide whether the answers received are correct or not. Such checks are under the responsibility of the national enforcement authorities. Companies could be fined if they do not meet their information duties. In Germany, the fines foreseen for administrative offence are up to 50.000 Euros , but apparently such a sanction has not been imposed so far. Competent authorities call also for sanctions in cases where the company did not act with due diligence and relied on the information received by the supplier without making sufficient efforts to find out whether this information is correct . Reasonable diligence would furthermore include the duty to consider information in the press, data published by consumer organizations, news about article recalls due to SVHCs, or knowledge about the expected presence of SVHCs in a certain article group or material. Due diligence can also include analytical testing commissioned by the company. Companies that provided wrong information about the SVHC content in their articles are required by law to pay for costs resulting from analytical surveillance tests by the enforcement authorities .
‘Restrictions are after the fact’ . This means in the case of SVHCs that restrictions are based on the identification of real unacceptable risks. As long as SVHCs are used in articles, exposures and risks are real. ‘Safety improved, but consumers are not yet safe’ . Therefore, the violation of SVHC provisions should not be regarded as trivial offence and must be prosecuted. A general absence of legal consequences in case of non-compliance with the information duty is the wrong signal for companies who take their responsibility seriously, phase out SVHCs in their articles, and respond to all consumer requests. ECHA’s position is that Art. 33(2) is an important right of consumers and the fact that suppliers do not reply may be a breach of this provision. ECHA encourages the consumers to contact the responsible enforcement authorities if suppliers still do not send an answer upon a renewed request.
The objective of the consumer’s ‘right to know’ is threefold: increase awareness on SVHCs in articles, support safe use of articles, and provide market incentives for substituting SVHCs. These aims are not fulfilled if the consumers do not seize the opportunity and request information, if the information is not understandable and workable for the average informed consumer, or if the respondents do not answer correctly or not at all. Practical experiences as presented here can contribute to the elaboration of feasible improvements in the course of the upcoming reviews of the REACH Regulation in the years to come (in 2017, second REACH review [1 Art. 117 (4)], 7th Environment Action Programme and the development of a non-toxic environment by 2018 , and assessment ‘whether or not to extend the scope of Art. 33 to cover other dangerous substances’ [1 Art. 138 (8)] by June 2019).
Improvements of effectiveness and effectivity of the current provisions
Optimized cooperation between ECHA and suppliers as well as education campaigns for industry and trade actors could support them on how to carry out their legal duties. Information flow in the supply chain can be simplified by a standardized format for communication on SVHCs in articles [9, 43]. If information requests are facilitated in all EU countries, e.g., by easy-to-use smartphone applications like ToxFox or Scan4Chem, the number of information requests by consumers could be increased, leading to an increased awareness of consumers as well as of suppliers. An official sample letter, such as the one proposed in Box 1, could facilitate the answers to the consumer requests for suppliers and could render the answers better understandable for consumers. However, an exclusive focus on SVHCs might distract consumers from other dangerous substances in everyday products. For example, if SVHCs are absent in the packaging of personal care products, this might lead to a false sense of safety as the personal care product itself in the container may contain heavy metals, potential sensitizers, or endocrine disruptors. The information duty should therefore be extended to mixtures (like personal care products) and it should not only include SVHCs, but also address substances that were identified to be of risk in other regulations (see also ). A full declaration of ingredients in articles could better cope with a growing candidate list and increasing information about other hazardous substances. The SVHC information does not give the consumer any information either about the chemical exposure by the respective article or about the aggregated exposure from various sources. This aspect should also receive more consideration in future. Improvements are needed in the suppliers’ responses to support safe handling of articles by consumers. In addition, clear criteria are needed for substituting substances which ascertain that the new ingredients are proven to be less dangerous than the substituted substance according to the present assessment criteria. The SINimilarity tool is a first help to avoid substitution by substances of similar hazard .
Effective surveillance and enforcement mechanisms by national enforcement authorities could lead to a fair situation which does not discriminate against companies that fulfill their duties well. In addition, more surveillance activities by authorities are needed to find out whether the information on the SVHC contents in the suppliers’ responses is correct or not. Fines or other enforcing measures that are already foreseen in legislation as described above should be applied to increase compliance. If consumers make informed purchasing choices and prefer SVHC-free articles, companies could profit from the competitive advantage using the information duty and the efforts to substitute SVHCs for a transparent and trustworthy communication with consumers.
So far, the current REACH information requirements for the supply chain are also applicable to articles produced in non-EU countries, but the enforcement is difficult. The Nordic Council estimated that large amounts of SVHCs are imported into the European consumer market, for example 900 tons per year of one SVHC with the import of shoes . The application of SVHC regulations and especially the authorization requirement to imported articles is in line with WTO law as shown in previous studies [48,49,50]. Extension of the authorization procedure to imported articles is not a violation to WTO rules against protectionism. This would also reduce a serious market disadvantage of European manufacturers and would generate a level playing field for all economic actors [49, 50].
Alternative or supplementary information tools on SVHC contents of articles should be considered. This could be the labeling of all contained SVHCs or even the full declaration of hazardous ingredients of an article on a package leaflet. Such a list could also contain information about potential risks and recommendations for safe use. Another option would be to make information on SVHCs in articles available in a European public open access database, fed and updated regularly with SVHC information by the responsible suppliers. As long as the consumers cannot retrieve the SVHC information by such alternative means, the maximum time limit for the answer should be reduced from the given time of 45–10 days. The experiences in the present study show that the majority of suppliers sent their answers already today in less than 10 days. Up to now, it is unclear whether missing answers should be interpreted as ‘the article contains less than 0.1% of any SVHC’ or whether the information request was ignored in the company. Therefore, the consumer should receive a confirmation of receipt of a request and suppliers should be liable to answer consumer requests in all cases.
It is worth to strengthen the ‘right to know’
REACH has established several elements that should lead to the gradual substitution of SVHCs: the information communication in the supply chain, the restrictions, the authorization requirement, and the consumer’s ‘right to know.’ The results suggest that the consumer’s ‘right to know’ in the present form is not very effective. More efforts are needed by all interested parties, i.e., regulators, manufacturers, importers, retailers, and consumers, to improve the implementation of this important information duty.
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I thank Eva Becker (German Federal Environment Agency) for fruitful discussions, Ulrike Kallee (Friends of the Earth Germany) for the data on the ToxFox application, and Ferdinand Schlichtig for support in the compilation of the data.
The author declares that she has no competing interests.
This article belongs to a series of contributions submitted from members of the Division of Environmental Chemistry and Ecotoxicology of the German Chemical Society (GDCh).
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Klaschka, U. Where are the SVHCs?. Environ Sci Eur 29, 24 (2017). https://doi.org/10.1186/s12302-017-0122-0