|Annex 1: Tools and legal frameworks for the identification of chemicals and related gaps for monitoring of products and articles possibly containing newly listed POPs|
|Annex 2: Voluntary schemes for the identification of chemicals in articles and related gaps in facilitating the monitoring of articles possiblycontaining newly listed POPs|
Systematic names are often long, complicated, and difficult to read for marketing and trade of chemical substances, mixtures, and articles. Therefore, generic names, proprietary or trade names, and trivial (common) names are used. A trade name is given to a chemical, a mixture or an article by the company that markets/supplies it. The trade name normally specifically identifies the chemical, mixture or article and sometimes gives information on the company.
One modelforhow to use trade names in the control of banned chemicals is the “UNEP Inventory of trade names of chemical products containing ozone depletion substances and their alternatives”. Related to this, the establishment of import and export licensing systems is mandatory for all Parties to the Montreal Protocol. Because those systems determine the accuracy and completeness of national ODS consumption data, by extension they are key tools to help measure and ensure compliance with the Protocol.
If trade names of all currently used chemicals and products of all newly listed POPs would be available and compiled, a similar system could be established. However, the available information differs for the different newly listed POPs. For example:
• For PFOS, its salts, PFOSF, and PFOS-related chemicals, there is very limited information available on trade names, and what is available is generally obsolete, e.g. information from the company “3M”, which stopped the supply of these chemicals by 2002. For commercial PentaBDE (c-PentaBDE) and commercial OctaBDE (c-OctaBDE), only some common names are available from the work of the POPRC.
• Only for lindane, endosulfan, and DDT is there an abundance of information on trade names available from the Chemical Abstract Service (CAS), INCHEM, and the Decision Guidance Documents (DGDs) of the Rotterdam Convention. From CAS, only trade names, common names, generic names, and synonyms are available for all three chemicals, but not company information. INCHEM PIM provides common names, synonyms, trade names, and company information not related to the trade names for endosulfan; common names, synonyms and trade names, but no company information for DDT; and, for lindane, common names, synonyms and trade names and company information not related to the trade names. For mixtures containing lindane, trade names with related company names for mixtures including information of the concentration of the active ingredient are provided.
• For endosulfan, the DGD from the Rotterdam Convention provides trade names, company (basic manufacturers) names not related to the trade names, and a general description of mixtures containing endosulfan as an active ingredient. For DDT and lindane, trade names, company (basic manufacturer) names not related to the trade names, and a general description of mixtures containing DDT or lindane as an active ingredient are available.
Available information is compiled in a document prepared as part of national implementation plans supporting documents a publication which provides the common name, chemical name, CAS number, HS code chemical, HS code mixture, trade names with source (POPRC, CRC, CAS, INCHEM; for PFOS: Environmental working group), trade name mixtures from INCHEM, information about mixtures from CRC, and company names from CRC/POPRC and INCHEM/Environmental working group.
As the different sources sometimes provide the same trade names for lindane, DDT, and endosulfan, the trade names were put into the database and the duplications and other mistakes, such as UN numbers, were removed. The resulting database, which includes more than 200 names for lindane, more than 100 for DDT, and almost 100 names for endosulfan, allows users to search the trade names for the three chemicals. The great number of trade names is also due to the fact that common names, synonyms, and trade names are collected together, that different forms of writing the same name were accepted, and that the same names are given in different languages. Except for endosulfan, the information sources are from 2000 onwards for lindane and from the 1990s for DDT.
Regarding lindane, many manufacturers are from countries that have long banned the chemicals and the company related trade names are expected to not be very useful for customs control or other control purposes. Therefore, it would be useful to collect additional information on trade names and companies for the other newly listed chemicals.
The only specific actual information for PFOS, its salts, PFOSF and PFOS-related chemicals is through internet search. In addition, through direct contact with the German company Lanxess, one PFOS-related chemical with trade name was identified. Information have been compiled as supporting information for the Stockholm Convention Guidance for the control of the import and export of POPs .
Gaps regarding trade names and mixtures
Information on trade names, companies, and HS codes for POPs as substances and in mixtures is mostly lacking for the totally banned newly listed POPs and PFOS, its salts and PFOS-related chemicals. For DDT and lindane, if such information is available, it is typically outdated.
Some trade names for PFOS have been compiled and listed. There is still a need to collect further information through other processes.
Such gaps might be addressed together with Rotterdam Convention activities: The Chemical Committee of the Rotterdam Conventiondecided at its seventh meeting (CRC7) in March 2011 to recommend the POPs chemicals endosulfan, PFOS, its salts and precursors, c-PentaBDE, and c-OctaBDE, for which two notifications met the criteria of Annex II of the Rotterdam Convention for listing in Annex III of the Convention. Meanwhile these substances have been listed.
The experience with the DGD for endosulfan from CRC6 shows that trade-related information, such as trade names, common names, and companies, is collected extensively in this process and documented in the DGD. Therefore, it is expected that the DGDs for the other POPs proposed for listing will also contain information on trade names, common names, and companies which could be used for the Stockholm Convention.
Trade names of articles and the time frame that contain POPs such as c-PentaBDE or c-OctaBDE and articles containing PFOS for exempted uses or acceptable purposes would be helpful for enforcement/control purposes. For example, regarding articles where specific trade names are used, such as for vehicles from a specific brand containing c-PentaBDE (here brand name; type and production year would be needed), or for electronic goods (e.g. TVs or computers) containing c-OctaBDE in the polymer. These might be gathered from monitoring studies.
Two POPs monitoring studies have recently presented monitoring data for POP-PBDEs/brominated flame retardants (BFR) in articles using bromine screening:
• BFRs in electronics: BFR have been screened with XRF in 382 plastic samples in Nigeria, in a project implemented by the Basel Convention Regional Coordinating Centre for the African Region (Ibadan/Nigeria). Information on products (producer, year, area of origin, and BFR content and type) has been compiled. The articles were analysed with GC/ECD for the individual BFRs. From these activities, a first data set on product names and POP-PBDE content were developed.
• POP-PBDE in carpet rebond: Recently, a monitoring project of POP-PBDE in carpet rebond was performed with XRF for bromine screening and 26 samples were analysed for POP-PBDE by GC/MS analysis. The levels of contamination and the names of products with higher levels have been published.
Gaps regarding trade names of articles containing newly listed POPs
The recent activities on identifying these articles (see work program on newly listed POPs proposed by POPRC and agreed by COP5) show that little information is available regarding trade names of articles. There is only very limited information available on POP-PBDE or PFOS in articles. The European Automobile Manufacturers Association has undertaken a survey on former c-PentaBDE and c-OctaBDE use in vehicles, but did not collect information for use before 2000 (after 2000 c-PentaBDE and c-OctaBDE has not been used in European vehicle production).
Producers of electronics have also not revealed if and for which years they have used POP- PBDEs in their products. Such information would therefore first need to be retrieved from the producers or generated by measurements.
Similarly, information on trade names of articles currently on the market and formerly sold (for articles still on the market for used goods, such as used vehicles or electronics) needs to be retrieved from the producers or otherwise be collected.
Emphasis has been given to collecting information about PFOS, its salt, PFOSF and PFOS-related chemicals (e.g. POPs name, CAS number, trade names, and uses). Also, the former use of POP-PBDE in the transport sector (company, model, and year) would be valuable. This information could also be requested from the electronic sector (company, model, and year).
While such information might be useful for monitoring the imports of vehicles, it likely would have only limited practical use for controlling used electronics since such electronics are often imported as mixed bulk in containers. To assess producer and product names for custom control seems impractical for electronics.
Published results for articles from recycled products, such as carpet padding studies, also have limitations. For example, some uncertainty exists when applying the results to other products from the same company with the same specifications since the POP-PBDE levels in recycled products might have fluctuation. Nevertheless, such studies are still useful for information on which companies are recycling POP-PBDE-containing materials as a first indication of possible POP-PBDE-containing goods.
It is also important to note that some articles have been found which formerly contained newly listed POPs (e.g. lindane for head lice treatment), but the producers have since changed formulation, yet kept the product name.
 Sindiku O, Babayemi JO, Osibanjo O, Schlummer M, Schluep M, Weber R (2012) Assessing POP-PBDEs and BFRs in E-waste polymers in Nigeria. Organohalogen Compounds 74, 1320-1223 http://www.dioxin20xx.org/pdfs/2012/1338.pdf
 Sindiku O, Babayemi J, Osibanjo O, Schlummer M, Schluep M, Watson A, Weber R (2014) Polybrominated diphenyl ethers listed as Stockholm Convention POPs, other brominated flame retardants and heavy metals in E-waste polymers in Nigeria. Env Sci Pollut Res. DOI: 10.1007/s11356-014-3266-0 (and supporting information).
 DiGangi J, Strakova J, Watson A (2011) A Survey of PBDES in Recycled Carpet Padding. Organohalogen Compounds 73, 2067-2070. http://www.dioxin20xx.org/pdfs/2011/4511.pdf.
 ACEA (2010) Personal communication ACEA - European Automobile Manufacturers Association, 2010.
The HS codes for chemicals listed in Annex III of the Rotterdam Convention are available from the World Customs Council through the website of the Rotterdam Convention:
• substance specific (for one or two substances): aldrin 2903.52, DDT 2903.62, dieldrin 2910.40, heptachlor 2903.52, hexachlorobenzene 2903.62, lindane (same as technical HCH) 2903.51, toxaphene (none)
• generic code (for ANNEX III entry) for mixtures containing these substances: 3808.50- generic code for polybrominated biphenyls (PBB) (hexa- CAS 36355-01-8, octa- CAS 27858-07-7, deca- CAS 13654-09-6) mixture 3824.84
For the other newly listed POPs, the following HS codes are available from the European Union (EU) Customs database ECICS:
• Chlordecone: 2914.70 Ketones and quinones, whether or not with other oxygen function, and their halogenated, sulphonated, nitrated or nitrosated derivatives
• Hexabromobiphenyl 2903.69 Halogenated derivatives of hydrocarbons, other
• Pentachlorobenzene 2903.69 Halogenated derivatives of hydrocarbons, other
• PFOS acid 2904.90 Sulphonated, nitrated or nitrosated derivatives of hydrocarbons, whether or not halogenated, other
• PFOS potassium salt 2904.90 Sulphonated, nitrated or nitrosated derivatives of hydrocarbons, whether or not halogenated, other
• Endosulfan: 2920.90 specific
The HS code, if chemical specific, can be used to identify the imported chemical. The HS code relates to a group of chemicals that also includes a POP might be used for the customs risk analysis but can not be used for inventory purpose.
Gaps regarding custom codes (Harmonised System Codes)
For most newly listed POPs, the custom code is not specific yet. Therefore, currently for these substances, custom codes have limited use. PFOS and POP-PBDEs have also not yet received a custom code.
 Korucu MK, Gedik K, Weber R, Karademir A, Karakus PBK (2014) Inventory development of perfluorooctane sulfonic acid (PFOS) in Turkey: challenges to control chemicals in articles and products. Environ Sci Pollut Res Int. DOI 10.1007/s11356-014-3924-2
The report of UNEP on chemicals in products states: “while currently there is no single global information system for management of information about chemicals in products, the GHS is an international standardized system for communicating chemical hazards. It addresses classification of chemicals by types of hazard and proposes harmonized hazard communication elements, including labels and safety data sheets. Its limiting factor is that it applies solely to chemicals and chemical compositions and not to products in general” – that is, articles.
According to the GHS, for a hazardous chemical or mixture the label should, inter alia, contain a product identifier for the hazardous chemicals and supplier identification. As a product identifier, the identity of a substance is to be provided by its common chemical name. The “common chemical name” may, for example, be the CAS name or IUPAC name, as applicable.
The CAS registry number provides a unique chemical identification and should be provided when available. Supplier identification consists of the name, address, and telephone number of the manufacturer or supplier of the substance or mixture.
For a mixture, the chemical identity, identification number (CAS number), and concentration or concentration ranges of all hazardous ingredients, which are hazardous to health or the environment within the meaning of the GHS, and are present above their cut-off levels, should be provided.
All POPs are hazardous chemicals and their chemical name and CAS number, together with supplier information, should appear on the label. There is no internationally agreed list of GHS classification and labelling of the newly listed POPs. To facilitate the customs control, the GHS classification and labelling as used by the EU has been integrated in Annex 1L of the POPs Labelling Considerations Document. The original data can be found in a database of the European Commission Joint Research Centre and the data for chlordecone, DDT, endosulfan, lindane, c-OctaBDE, c-PentaBDE, PeCBz, PFOS and its saltsare available in Annex 1L of the POPs Labelling Considerations Document with explanations regarding the hazard classcodes, hazard statements codes, and label information. Therefore, the EU has developed labelling for all of the POPs except HBB. The GHS might be useful to some extent for controlling POPs in articles.
Gaps regarding GHS classification and labelling
While the GHS is an international standardized system for communicating chemical hazards, it is not yet the single global information system for the management of information about chemicals in products. Currently, 67 countries are listed as implementing GHS and many other countries are preparing for implementation. Many developing countries in particular might need additional support for preparation and implementation.
Concentration levels below 0.1% are normally not covered in the GHS label. However, there are possibilities to lower this generic value. For POPs, such levels would need to be defined.
A Synthesis of Findings Under the UNEP/IOMC Project on Information on Chemicals in Products, UNEP / DTIE Chemicals Branch February, 2011 http://www.chem.unep.ch/unepsaicm/cip/Documents/CiP%20Project%20synthesis%20report__Final.pdf.
 Table 3.1 in 1.4 GLOBALLY HARMONIZED SYSTEM OF CLASSIFICATION AND LABELLING OF CHEMICALS (GHS), Fourth revised edition, UNITED NATIONS, New York and Geneva, 2011.
 Production of HBB stopped in 1976 and therefore has no relevance as a traded chemical.
A Material Safety Data Sheet (MSDS), Product Safety Data Sheet (PSDS), or Safety Data Sheet (SDS), is a form that provides data on the properties of a particular substance. SDSs are a widely used system for cataloguing information on chemicals, chemical compounds, and chemical mixtures. The chemical supplier (e.g.manufacturer, importer, or formulator) should be able to provide detailed information about the chemical in an SDS. In certain countries, the supplier is obligated to provide information in an SDS on the chemicals’ health and environmental hazards, labelling, safe use and handling, among other things. SDSs have been prepared on many dangerous substances and preparations.
An SDS should go together with the product to the user in the workplace. It should provide comprehensive information about a chemical substance or mixture for use in a workplace setting. It can be used by both employers and workers as a source of information about hazards, including environmental hazards, to obtain advice on safety precautions, and most importantly to identify appropriate risk reduction messages for the related uses. Advice by the supplier on the safe use of the chemical by the user requires information on the workplace situation of the user and expected exposures. The information in an SDS acts therefore as a reference source for the effective management of hazardous chemicals in the workplace.
The SDS is product related and, sometimes, may not be able to provide specific information that is relevant for a specific use. In other cases, the SDS may be specific and detailed for a particular use. The SDS is a resource that enables an employer to undertake worker and environmental protection activities, including training that are specific to the individual workplace.
Gaps regarding safety data sheets
The SDS is an essential component of the GHS framework. It does not provide more information for identification than the GHS label. As with the GHS, chemicals at concentrations below 0.1% are not listed in SDSs. Often only the main compounds are listed.
One experience, within the newly listed POPs project in Nigeria, was that no SDSs were provided with imported fire-fighting foams since there is no requirement for SDSs in the country. This might be the case for many developing countries.
Certificate for RoHS compliance
For compliance with RoHS Directive, a compliance certificate/label exists. This covers PBDEs (c-PentaBDE, c-OctaBDE, and c-DecaBDE) and HBB as well as certain heavy metals (lead, mercury, cadmium, and hexavalent chromium). Although RoHS was developed for the EU, companies comply worldwide with the standard due to import requirements of the EU and the development of similar regulations in other countries.
The RoHS standard can be seen as success story. There are also several countries with RoHS-like legislation (including Australia, Canada, China, Japan, Republic of Korea, and the United States (US)) making RoHS a “global legislation”. The EU RoHS Directive has recently been updated and extended.
Gaps regarding the RoHS certificate
The RoHS limit is 0.1% for POP-PBDEs and HBB and therefore about an order of magnitude above the low POPs content of PCB (50 ppm) or POPs pesticide (50 ppm). Furthermore, the definition and measurement of PBDEs in RoHS differ somewhat from the Stockholm Convention. In RoHS, for example, the OctaBDE homologue is also included, but not considered as a POP in the Stockholm Convention, and therefore the total content is calculated slightly different. Also, DecaBDE (by far the most abundant PBDE in articles) is included in RoHS, but not in the Stockholm Convention.
Labels for articles based on the POPs content
Dedicated labels for articles with a specific material exist for plastic and asbestos. A more general labelling requirement is included in California’s Proposition 65 (the Safe Drinking Water and Toxic Enforcement Act of 1986) which requires “clear and reasonable warning” about chemicals in products that are associated with cancer or reproductive toxicity.
A specific label might also be developed for POPs. For the listing of HBCD a labelling of products containing HBCD will be required from 26 November 2014 on. For POPs as substances or in mixtures or articles, the label could contain the name of the POP if the concentration is above a certain cut off value.
Countries could also consider dedicated labels for POPs in articles which are not covered by the GHS. In principle, this could be applicable to all articles manufactured that contain a regulated POP. (Also see the POPs Labelling Considerations Document of the Stockholm Convention.)
Key stakeholders and resources required for implementation include:
• Manufacturers to identify the POPs and label the article.
• User industries, workers, farmers, and the public, using the information to protect human health and the environment.
• Governments to provide awareness raising, training, as well as monitoring the obligation to label.
• An efficient customs monitoring system to identify unlabelled imported articles and to control manufacturers producing the regulated articles.
Gaps regarding a “POPs label”
A “POPs label” has not yet been developed and would require considerable time and effort to establish. Furthermore, it is questionable whether development of a label only for POPs is justified considering the relatively small amount of goods to be labelled and the related effort. Additional resources would also be required to educate and train customs staff and other competent authorities and to motivate them to consider such labels.
 DecaBDE degrades over time to the lower brominated PBDE including POPs PBDEs (UNEP/POPS/POPRC.6/INF/20).
The European chemicals legislation REACH was developed and implemented in order to overcome some of the core problems in the EU’s chemicals management, such as the lack of information on hazardous properties for the majority of substances on the market, the unequal treatment of substances marketed before and after 1991 (existing substances and new substances), the slow progress of authorities in the risk assessment of prioritised substances, and the patchwork of different pieces of legislation (lack of coherence). The requirements of the Stockholm Convention are implemented in a separate regulation at the EU level. The main aim of REACH is to ensure the safe handling and use of substances on the market while enhancing innovation and competitiveness by different mechanisms.
The core REACH process of registration requires all manufacturers and importers of substances, in mixtures, and in articles from which they are intended to be released to submit a registration dossier to the European Chemicals Agency (ECHA), if these are manufactured or imported in amounts exceeding 1 t/a. For substances registered in amounts exceeding 10 t/a, a chemicals safety report must be compiled; for substances fulfilling the classification criteria as hazardous, an exposure and risk assessment for all lifecycle stages must also be compiled.
ECHA may carry out an evaluation of industries’ dossiers and both ECHA and the EU Member State authorities conduct evaluations of substances which are suspected of being of concern. The authorisation process consists of several steps, at the end of which the use of substances of very high concern (SVHC) may be prohibited, except where the user has been granted an authorisation. The formal identification of substances as SVHCs and their inclusion in the candidate list for authorisation triggers communication requirements for article producers and distributors. The restrictions process aims to regulate substances posing a risk to human health or the environment at the EU level by restricting or banning the manufacture, import, and use of specific substances, in mixtures, or in articles.
The scope of REACH excludes active substances in biocide and pesticides, as well as substances which are not intentionally manufactured (e.g. dioxins). Furthermore, wastes are outside its scope. Therefore, some of the current and potentially future POPs are not regulated by REACH.
REACH does explicitly regulate the export of substances; i.e. substances manufactured for export neither have to be registered nor can they be subject to authorisation. Only the ban of manufacturing would be effective (e.g. by a restriction).
POPs which can be legally manufactured and traded in the EU as such and in mixtures may be registered in the EU. The identified uses will be reported as part of the chemical safety report if one is required and recommendations on adequate control of risks from their use will be forwarded with the SDSs. The information will be published in the ECHA dissemination database.
The basis for registering substances is the definition of the substance identity. Detailed rules on how to name and characterise different substance types are provided in a guidance document by ECHA, which inter alia sets thresholds for identifying impurities and additives of a substance. Consequently, the POP content in substances may be reported by registrants; although part of the database, it is not published because the substance identity is considered confidential business information.
If a persistent bioaccumulative toxic substance (PBT) or a very persistent very bioaccumulative (vPvB) (such as POPs) or substances transforming into one are contained in a substance above 0.1%, a PBT-specific risk characterisation should be performed, according to the ECHA guidance on PBT assessment (exemptions possible if total amount below 1 t/a), potentially resulting in specific information to be forwarded with the SDS (emission minimisation).
PBT/vPvBs (such as POP) have to be identified in SDSs if they are contained in substances or mixtures above the thresholds for consideration according to the classification, labelling and packaging (CLP-) regulation. This information is available in the supply chains. Mixtures and their content are not registered or reported under REACH.
POPs may be identified as SVHC and included in the candidate list for authorisation, if they fulfil the criteria of Article 57. Article 57(f) in principle could be used to identify substances as SVHC because of their transformation products being SVHC or because of their content of SVHC(s).
For all substances on the candidate list, the article producers and importers are to report to ECHA the content of these substances in their articles, if the total amount of any individual SVHC in concentrations above 0.1% exceeds 1 t/a. They can claim exemptions to that if the substance is already registered for the use or if they can prove that there is not exposure of humans or the environment from the article.
Apart from reporting to ECHA, article producers and importers are to communicate to their commercial customers information on the content of SVHC(s) on the candidate list in their articles if they contain above 0.1% and forward information necessary to ensure safe use. This requirement applies regardless of the total tonnage. This information could be a starting point for monitoring SVHC in articles and for targeting inspection and control campaigns.
POPs which may become subject to authorisation (as such or as impurity in substances on the list for authorisation) will be particularly controlled because they only may be used by companies which have an authorisation. All users of substances subject to authorisation have to report their use of the substance to ECHA. ECHA maintains a register of respective downstream users and grants access to Member State authorities. This mechanism allows identification of all companies which use an authorised substance. This is also an entry point to identify where they are included in articles.
The restriction process is useful to limit the manufacture and/or use of substances inside the EU and from imports. However, no monitoring instruments are available, except those stemming from the enforcement of the requirements (e.g. see RAPEX).
Gaps regarding REACH
Chemical safety reports only contain generic use patterns, and no specific information on who uses a substance for/in which specific product. Hence, it is possible to use that information to target monitoring or inspection programmes, but it does not provide direct information on the occurrence of POPs on the market.
Registration of substances and related identification of potential POPs contained in them only starts at concentrations above 0.1% and volumes of 1 t/a per registrant; i.e. substances manufactured or imported in smaller volumes are not assessed. Importers of substances contained in mixtures are not likely to obtain or generate that detailed information on the substance content as to be able to identify whether or not POPs are contained.
The registration information for a (POP-containing) substance is not linked to any specific products or uses, but rather only generic use patterns are provided for substances for which a chemical safety assessment and exposure assessment must be carried out.
As substances are only registered as such, even if they are imported in mixtures, no information on that mixture will be reported to the ECHA database. Consequently, although the supply chain actors may be aware of a POP in a mixture, that information is not structurally available for monitoring or controlling POPs at the EU level.
Reporting the content of candidate substances to ECHA would in principle be a helpful tool to monitor the flow of POPs (those which are included on the candidate list) on the markets. However, it is already clear that only limited information will be obtained via this track because of several reasons. These are, inter alia: tonnage and the concentration thresholds for SVHCs in articles (0.1% in articles for reporting and communication) are too high and only in a few cases, the reporting requirement applies; the exemption from the reporting obligation will apply to many potential reporting cases; and the sanctions for breaching either article related requirement (reporting to ECHA and communicating to customers) are very low and not likely to motivate in particular the importers of articles to conduct extensive testing to identify SVHCs.
REACH is a substance-oriented regulation, primarily aiming at ensuring the safe handling and use of substances on the market by generating and disseminating hazard, exposure, and risk information. The specific processes of candidate listing, authorisation, and restrictions aim at controlling risks from the most hazardous substances could also be used for POPs. It is not likely, however, that major changes to the regulation will be made to include product- or article-related requirements, which would also facilitate the monitoring and control of POPs, before the end of the last registration period in 2018.
 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
 Regulation (EC) No 850/2004 on persistent organic pollutants.
 This process corresponds to the former EU risk assessment under the Existing Substances Regulation however with defined responsibilities and timelines aimed at ensuring an efficient work process.
 The criteria for “very high concern” are set out in REACH Article 57 and are hazard based. The following substances properties are listed: CMRs category 1a and 1b, PBTs, vPvBs and substances with similar properties or potential adverse effects.
 Substances recovered as such or contained in recovered materials are however regarded as “manufactured” and fall under the scope. Exemptions from registration may be claimed based on Article 2.7(d).
 Registration of substances in articles is only required if they are intended to be released. This is a specific case and not further discussed here. For details refer to the ECHA guidance on substances in articles: http://echa.europa.eu/documents/10162/13632/articles_en.pdf.
 Currently HCBD is on the list.
 There are different interpretations as to the reference unit of 0.1% “in the article“. The European Commission, ECHA, and the majority of Member States use the article “as placed on the market” as reference for the threshold whereas the so called “dissenting Member States” relate the 0.1% threshold to the component or article part, which became an article according to the REACH definition for the first time.
 The article producer is to sum up all individual amounts of each SVHC separately which is contained above 0.1% in any of the articles the producers produces or imports. SVHC in concentrations below 0.1% are not considered.
 This information is to be provided to consumers upon their request free of charge and within 45 days.
RAPEX (Rapid Alert System for Non-Food Consumer Products) is the EU rapid alert system for all dangerous consumer products, with the exception of food and medical devices. Meanwhile, the alert system also covers pharmaceutical products and in this respect is also reporting to an international UN body (WHO). The system allows for the rapid exchange of information between Member States via central contact points and the European Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers, which may be available in more than two Member States. RAPEX covers reporting on measures ordered by national authorities, and measures taken voluntarily by producers and distributors.
Hazardous chemicals are addressed within RAPEX and chemical risk is ranked as the fifthcategory within RAPEX notification and has a relevant share (13%) (European Commission, 2007). Each Member State has designated competent market surveillance authorities and granted them with the necessary powers to take measures in order to prevent or restrict the marketing or use of dangerous products. More specifically, the national authorities are competent to take samples of consumer products placed on the market, to test them in laboratories, and – in cases where these products pose risks to consumers – order producers and distributors to stop their sale, withdraw them from the market, and/or recall them from consumers.
Gaps regarding RAPEX
Currently, POPs are not specifically addressed under RAPEX. RAPEX is mainly an instrument within the EU. However, as with pharmaceutical products, it is already linked to the UN (WHO). In addition, RAPEX China indicates that such a system has the potential for extension beyond the European region.