Article exemption

SI 1985/1048 Radioactive Substances (Luminous Articles) Exemption Order... 

Article Exemptions. You do not have to factor into threshold or release determinations quantities of a listed toxic chemical contained In an article when that article is processed or used at your facility. An article is defined as a manufactured item that is formed to a specific shape or design during manufacture, that has end-use functions dependent in whole or in part upon its shape or design during end-use, and that does not release a toxic chemical under normal conditions of the processing or use of that item at the facility. 

The article exemption applies to the normal processing or use of an article. It does not apply to the manufacture of an article. Toxic chemicals processed into articles produced at a facility must be factored into threshold and release determinations. 

Basically, if the product will be processed in some way after leaving the manufacturing site—cheated, welded, glued, sawed, etc.—and a hazardous chemical could be emitted, it probably will not qualify for the article exemption. 

Machinery found in the workplace that may contain hazardous chemicals does not fall imder the definition of a container therefore, the machine components do not have to be labeled rmder HCS. If there is the potential for exposru-e to the hazardous chemicals associated with these machines, the article exemption does not apply, and these chemicals wordd be covered by the rule. 

If the processing or otherwise use of similar articles results in a total release of less than 0.5 pound of a toxic chemical in a calendar year to any environmental media, EPA will allow this release quantity to be rounded to zero and the manufactured items remain exempt as articles. EPA requires facilties to round off and report all estimates to the nearest whole number. The 0.5 pound limit does not apply to each individual article, but applies to the sum of all releases from processing or use of like articles. 

Since your facility employs more than 10 people and falls withinSIC codes 20-39, yourfacilitymust reporl under section 313. [Note Once any of the applicable thresholds for lead compounds are exceeded, you are required to idenlify all manufacturing, processing, and use activities. You must report all releases of all lead compounds present at your facility, regardless of the activity from which they originate unless there Is a specifically exempted use, such as the use of an article or use of intake water naturally containing lead.]... 

Waste fractions leaving the recycling process of waste as a recovered material have to fulfill the obligations of the REACH regulation, but with certain privileges. Article 2(7d) provides under certain conditions for an exemption from registration (Title II), downstream user regulations (Title V), and evaluation (Title VI) [10] ... 

We are told here that the European Commission is currently revising the way in which it grants exemptions to its ban on HCFC-14 lb blowing agents, under the terms of its ozone-depleting substances (ODS) regulations. The reasons for this move are explained fully in this informative article. EUROPEAN COMMISSION ATOFINA SOLVAY HONEYWELL... 

Cefic claims that polymeric materials, reaction intermediates and substances used for R D should not be subject to the REACH evaluation and authorisation process being proposed by the European Commission in its White Paper on future chemicals policy, it is briefly reported. On specific issues, Cefic wants a risk-based approach to chemicals assessment and regulation realistic deadlines for the REACH process and exemption from REACH of finished articles, so that it applies only to substances marketed as substances or as constituents of a preparation. 

Details of the regulation are given including systematic data reporting and establishment of lists of priority substances, risk evaluation, list of existing substances produced or imported within the Community in quantities exceeding 1,000 tonnes per year, and list of substances exempt from the provisions of Articles 3 and 4. 

Article 8(1) of the Sixth Amendment specifies three different types of exemptions for R D substances. The third appears to be analogous to the TSCA 5(h)(1) exemption for test marketing activities. 

The Commission amended Annex II on 27 June 2002 and the decisions of the amendment are in force since 1 January 2003. The amendment clarifies the need of such an Annex, which in some respect reverses the good provisions of Article 4 (2) (a). According to the Commission certain materials and compounds continue being exempt from phase-out because they are still unavoidable. The body has, however, decided to delete lead that is used for coating inside petrol tanks from this Annex, since the use of this element is already avoidable. 

National legislation which lay down a general prohibition on the use of Trichloroethylene for industrial purposes and establishes a system of individual exemptions, granted subject to conditions, is justified under Article 36 of the EC Treaty (now, after amendment. Article 30 EC, on the grounds of protection of health of humans. ... 

This list of substances has to be reviewed and extended by the parliament and the council as soon as further scientific evidence on other hazardous substances is available which recommends their substitution with safer alternatives. Materials or components of electrical and electronic substances can only be exempt from the substitution provision if their replacement is not scientifically ortechnically practicable or if there are no safer alternatives. Annex 1 of the directive specifies in detail which applications of lead, mercury, cadmium and hexavalent chromium fall under the above-mentioned exemption. However, these exemptions also need to be reviewed every fouryears (Preamble 11 and Article 5 (b) and (c))... 

REACH is very wide in its scope covering aU substances (see definition of substances in Section 2.4.1) whether manufactured, imported, used as intermediates or placed on the market, either on their own, in preparations or in articles, unless they are radioactive, subject to customs supervision, or are nonisolated intermediates. Waste is specifically exempted. Food is not subject to REACH, as it is not a substance, preparation, or article. Member States may exempt substances used in the interests of defense. Other substances are exempted from parts of REACH, where other equivalent legislation applies for fiufher details refer EU (2006i). 

The provisions of Article 23(a) require the MAH to inform the competent authority about various activities associated with the availability of the product on the market. Under Article 24 of the revised legislation only a single renewal is required when the product has been authorised for 5 years. A second renewal may take place after a further 5 years if there are justified pharmacovi-gilance groimds. In addition, any authorisation, which is not followed by placing the product on the market within 3 years (or which is not present on the market for 3 years), shall cease to be valid. Member States may grant exemptions from the 3-year rule, if justified on public health grounds. 

The provision of samples is not permitted for any medicine which contains a substance listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the medicine is not a preparation listed in Schedule III to that Convention) or a substance listed in any of Schedules I to IV of the Psychotropic Substances Convention (where the medicine is not a preparation which may be exempted from measures of control in accordance with Paragraphs 2 and 3 of Article 3 of that Convention). 

The term substance of very hi h concern, abbreviated SVHC, is associated with a new process that was introduced to the European chemicals policy through the implementation of REACH the authorization process. This procedure aims (1) to encourage the substitution of substances of very high concern with less harmful substances or alternative technologies and (2) assure the proper control of risks arising from SVHC s. A substance being subject to authorization must principally not be used or placed on the market for any use within the European Union. However, specific uses of an authorized substance may be excluded from this general prohibition if, for example, they are a priori exempted from authorization or if the manufacturer, importer, or downstream user successfully applied for their authorization. The authorization process is laid down in REACH Articles 55-66 and may be initiated by the ECHA on behalf of the European Commission or by EU member state competent authorities. Substances which are subject... 

Many of the issues relating to the definition of nonchni-cal laboratory study were addressed in the discussion of GLP 58.1 (Scope). Field trials in animals includes all efficacy studies of new animal drugs. Such studies are outside the scope of the GLP regulations. This is consistent with the GLP exemption for human clinical trials. The exemption for basic exploratory studies carried out to determine whether a test article has any potential utility would extend to early screening studies of a test article, the results of which are used to determine whether a test article merits further development or not. 

Merola and Crichlow (2004) have argued that if the Commission applied Article 87(1) to the whole scheme, Article 87(3)(b) would authorize the entire allowance allocation scheme . Under this approach, such an exemption would cover all emissions and make it unnecessary precisely to establish the proportionality of the aid to the environmental benefit to be secured under the EU ETS because the compensatory justification would be implicit in the fulfilment of the specific requirements of Article 87(3)(b), as indicated in paragraph 73 of the [Commission s] Guidelines .22 This claim illustrates the key importance of careful identification of the precise ground upon which any exemption is sought from the prohibition on the grant of State aid. This issue will be addressed in the discussion of the proportionality principle (Section 3.2.5), where it will be argued that proportionality must still be respected under the EU ETS. 

In the EC Treaty itself, there are both automatic and discretionary exceptions from the prohibition, although both require Commission approval after notification of the aid by the Member State. Under the Treaty, legislation has been adopted to exempt various aids from the prohibition, in the style of the Block Exemptions used to give effect to the exemption in Article 81(3) EC. (See Joined Cases T-447/93 and T-448/93 AITEC v. Commission [1995] ECR 11-1971.)... 

Seethe EU ETS Directive, Recital 23 ( without prejudice to Articles 87 and 88 EC), Article 11(3) and Para. 5 of its Annex III. Indeed, it seems unlikely that the relevant provision in the EC Treaty (Article 175(1) EC, which conferred power upon the EC to adopt environmental legislation such as the EU ETS Directive) would allow the adoption of any wholesale exemption that would not be compatible with the provisions on State aid. 

The Chemical Substances Control Law regulates chemical substances produced by chemical reaction excluding natural products. However, articles and substances regulated by other laws, such as the Food Sanitation Law in Japan and the Pharmaceutical Affairs Law, and exclusively used for the purposes covered by such laws, together with substances used for research and development, are also exempt from the Law. 

Compliance with Federal Statutes The fact that an article appears in the Food Chemicals Codex or its supplements does not exempt it from compliance with requirements of acts of Congress, with regulations and rulings issued by agencies of the United States Government under authority of these acts, or with requirements and regulations of governments in other countries that have adopted the Food Chemicals Codex. Revisions of the federal requirements that affect the Codex specifications will be included in Codex supplements as promptly as practicable. 

Centralisation occurs within the registration process, which reallocates some of the tasks formerly carried out by NRAs to ECHA. Following Article 5 of the REACH Regulation, all chemical substances, chemicals in preparations and in articles must be registered (provided they are not subject to listed exemptions). After a transition period, any chemical that does not bear a registration number should be taken out of circulation. 

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