REACH FAQ for DUMMIES
Since the implementation of REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation in June 2007, a number of key provisions have been progressively executed including pre-registration of phase-in substance, the first SVHC (Substances of Very Concern) candidate list of 15 substances and supply chain communication on the safe use of the articles. REACH gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. 1 June 2009 will be another upcoming compliance date for more provisions. While Directive 76/769/EC will be repealed by restriction provision of the REACH regulation (Annex XVII), the first SVHC list subjected to authorization (Annex XIV) will be duly released. So are you ready to prepare?
Given the inherent complexity and technical difficulty of the REACH regulation and associated guidance documents, you may still find your actual obligations unclear; this is particularly true if you are non-European Union (EU) article manufacturer or importers that do not produce chemicals or preparations. This FAQ document is aimed to highlight some of the areas that may be confusing to you as a professional faced with the challenges of REACH.
Q1. While REACH is a chemical-related regulation, why do manufacturers of physical, tangible products need to worry about a chemical management policy? Under REACH, those physical, tangible products (e.g. toys, cutlery, garments, and electrical appliances including the smaller components and spare parts that are integral to the product’s function) are generally to be classified as articles. They are manufactured with and from various chemical substances. In addition to establish the chemical inventory within the European Community, REACH also aims to better control the use of dangerous substances (restricted substances and SVHC), this obviously includes the restriction of certain substances or certain uses. The use of dangerous substances on those physical, tangible products is also covered.
Q2. Does REACH affect companies outside the European Community? Being a regulation that only has legal effect within jurisdictions that have adopted its legal framework, REACH obligations only fall on those companies with a legal presence (e.g. manufacturers, importers, retailers, etc.) within the 30 implemented European countries. Therefore, companies established outside the Community that are exporting their products into the customs territory of the 30 countries are not bound by the obligations of REACH.
However, companies outside the Community may wish to support its business partners established in the European Community in order to facilitate its business activities. They may be required to provide their customers with REACH information on the content of the products that they supply to customers.
Q3. What if a phase-in substance is not pre-registered by 1 December 2008? 1510245(a) First-time Manufacturer or Importer: Only if the company is a so called first-time manufacturer or importer of that substance in quantities of 1 tonne or more per year after the pre-registration deadline has passed. Manufacture or import for the first time, refers to the first time after the entry into force of REACH (1 June 2007). First-time manufacturers or importers must pre-register within six months after the first manufacture or import reaches the 1 tonne threshold, and not later than 12 months before the relevant deadline for registration. The same applies for imported articles that contain a phase-in substance for which registration is required.
(b) Current Manufacturer or Importer: A company that fails to pre-register a phase-in substance by the pre-registration deadline may neither import nor manufacture it after that date until it has fully registered the substance with European Chemical Agency (ECHA).
Q4. What article is considered containing substances intended to be released? The intended release of substances as such or in preparations from an article normally applies to an accessory function of an article. If an article has an accessory function, which is achieved through the release of substances or preparations during normal and reasonably foreseeable conditions of use, then the release is to be regarded as intended. The guidance document published by ECHA in May 2008 explained scented eraser and pantry hose with lotion are the examples of this type.
It is worth noted that ink cartridges, toner cartridge and wet cleaning wipes are not considered articles with intentional release. These items are special containers containing a preparation. The cartridge and wipe carrier material are merely a delivery mechanism for a preparation that may contain substances that need to be registered.
Q5. When is Safety Data Sheet (SDS) required? SDS should prepare for the following substances or preparation regardless of product volume according to Article 31 of the REACH regulation.
1510245(a) Dangerous according to 67/548/EEC or 1999/45/EC(b) PBT (Persistent, Bioaccumulative and Toxic) or vPvB (very Persistent and very Bioaccumulative)
(c) SVHC listed in Annex XIV
(d) Not classified as dangerous according to 1999/45/EC but posing human health or environmental hazards
(e) Exists a community workplace exposure limits Q6. Given that consumer products like toys, clothing and electrical appliances are classified as articles, what are the REACH requirements for these products? Generally, there is no known or intended release of chemical substances under normal or reasonably foreseeable conditions from the use of these consumer products, the obligation to register or provide safety data sheet for substances that are intended to be released for article does not apply to these products. The major concern for the products of this type will be the possible SVHC presence in the products. As Directive 76/769/EEC is going to be repealed by REACH in June 2009, any amendment in the requirements for restricted substances inside the articles should be kept update.
Q7. Are electronic products still required to concern RoHS compliance requirement? REACH is a general chemical policy to disclose information on hazardous substances. Existing product specific directives/regulations such as RoHS for electronic products, EN71 Safety Standard for toys and Regulation 1905/2004/EC for food contact material are still valid to regulate their respective product scopes. Therefore, products are required to comply the relevant stipulations of these directives/regulations in addition to fulfill the REACH requirement.
Q8. What are the obligations of packaging materials and containers? Packaging materials and substance/preparation containers may be produced or imported separately as packaging of imported goods. The guidance document published by ECHA in May 2008 revealed that the packaging material or container is always a separate “article” and to be assessed separately from any object it contains. The obligations for articles also apply to packaging materials and containers.
Q9. What are the requirements of an article containing SVHC appearing on the Candidate List and/or Annex XIV? The criteria to be classified as SVHC have been explicitly stipulated in Article 57 of the REACH regulation. Substances meeting these criteria may be placed on one or both of two lists that are defined in the REACH regulation: the so called “Candidate List” and “Annex XIV List”.
1510245(a) Candidate List: Two key provisions are required to consider if an article containing SVHC listed in the Candidate List. Firstly, notification to ECHA is required if any of the candidate SVHC in articles is present at greater than 0.1% weight by weight (w/w) and the total amount exceeds 1 tonne per year per producer or importer. Secondly, any of the candidate SVHC is present above 0.1% (w/w) in the article, it is obligatory to inform the recipients of the article along the supply chain about the chemical name(s) and how the article can be safely used.
(b) Annex XIV List: The list will be selectively drawn from the Candidate List published by ECHA. Those SVHC listed in Annex XIV will not be allowed to be used, placed on the market or imported into the EU after a date to be set unless the company is granted an authorization for specific uses.
Q10. Regarding on the SVHC in the article, what is meant by 0.1% by weight? Is it against the entire article, homogenous material or something else? The REACH regulation stated that SVHC notification trigger is for those substances “in a concentration above 0.1% (w/w)”. The guidance document published by ECHA in May 2008 further clarified this to mean 0.1% weight by article weight, rather than at the homogenous material level. However, several EU member states including Austria, Belgium, Denmark, France, Germany, and Sweden have explicitly disagreed with this interpretation and argued the validity of the homogenous material/component level to ensure the protection of human health and the environment. While the legal interpretation needs to be resolved by a European Court, clients are recommended to consider the worst-case scenario (i.e. homogenous material/component level).
Q11. How does the SVHC Candidate List develop? A potential SVHC may be prioritized by the 30 national REACH Competent Authorities or by ECHA at the request of the European Commission, and a dossier prepared for nomination of the substance for inclusion on the Candidate List. The list of proposed substances is then released on ECHA website at http://echa.europa.eu and invites all interested parties to voice their scientific comments on the identification of the substance as SVHC and any additional information related to exposures, safer alternatives and potential risks within a set timeframe. If no comments are received, the substance will be automatically included on the Candidate List. However, if comments are received, ECHA will refer the dossier to its Member State Committee where agreement will be sought as to whether the substance meets the SVHC criteria. If there is failure to reach a comprise agreement at the Member State Committee, then the European Commission will prepare a draft proposal on the identification of the substance and a final decision subsequently taken in accordance with the comitology procedure laid out in Article 133 of the REACH regulation.
Q12. Should those articles containing SVHC less than 0.1% (w/w) be considered for the purpose of notification to ECHA? Notification to ECHA will apply to those articles containing candidate SVHC greater than 0.1% (w/w). Concerning the one tonne per year threshold, producer or importer are only required to count those articles containing candidate SVHC greater than 0.1% (w/w).
What’s next? Should you immediately take any concrete action to ensure your compliance this regulation and/or enable your business remain competitive on the EU market? Please let us know your next step. SGS is committed to supporting industries for REACH compliance with diversified solutions.
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