Annexes amendments

EC Directive amending Annex II to Directive 90/642/EEC relating to the fixing of maximum levels for... 

EC Directive amending Annex III to Directive 77/93/EEC on protective measures against the introduction... 

In a sense, the articles equate to what you might expect to find in an Act at national level, while the content of Annexes would be more akin to what would be placed in regulations. There is also a parallel in terms of authorisation, in that amendments to the articles usually require the approval of the political institutions, whereas adaptation of the Annexes to technical progress is possible via a decision of the Commission, functioning as the executive body. You can see this in practice by just looking at the title of each instrument that you read. 

Fundamental tothis strategy isaprocedurefordassificationofdevicesintooneoffour categories classes I, Ila, I Ib or 111. Manufacturers must classify their devices according to criteria and rules set out in Annex IX to the directive, as amended. As a first step, the manufacturermustclearlydefinetheintendeduseofthedeviceintermsof (i) degree of invasiveness (ii) mode of action, whether active or passive device (iii) the duration of contact with the patient and (iv) impact on the body, local versus systemic effect. 

CEC. 1982. Proposal for a council directive amending Annex II to Directive 76/895/EEC relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables. Off J Euro Comm C95 6-10. 

Commission Directive 96/46/EC of 16 July 1996, amending Annex II to the Directive 91/414/EEC, is the basis for the assessment of residue analytical methods for crops, food, feed, and environmental samples." Provisions of this Directive cover methods required for post-registration control and monitoring purposes but not data generation methods. Because it is necessary to provide applicants as precisely as possible with details on the required information, the guidance document S ANCO/825/00 rev. 6 dated 20 June 2000 (formerly 8064/VI/97 rev. 4, dated 5 December 1998)" was elaborated by the Commission Services in cooperation with the Member States. 

As discussed before, the efficiency of the extraction step is one of the fundamental performance characteristics of an analytical method. Unfortunately, the provisions regarding extraction efficiency in Council Directive 91/414/EEC (amended by Directive 96/68/EG) are listed in the metabolism section of the directive (Annex IIA 6.1 and 6.2). Nevertheless, results obtained in these studies are essential for the development of enforcement methods and must be reflected in this context. 

With respect to development pharmaceutics data, the requirements stated in Directive 75/318/EEC (as amended) are included in the Annex to that document at Part 2 A 4 (page 20 of the Rules Governing Medicinal Products in the European Union, Volume 1, Pharmaceutical Legislation Medicinal Products for Human Use). With respect to the general requirement for pharmaceutical products this states 4.1 An explanation should be provided with regard to the choice of composition, constituents and container and the intended function of the excipients in the finished product. This explanation shall be supported by scientific data on development pharmaceutics. The overage, with justification thereof, should be stated. This, then, is the legal requirement. Needless to say, there is a... 

CPMP/QWP/054/98 corr Annex to note for guidance on development pharmaceutics—Decision trees for methods of sterilisation (February 1999, amended after February 2000)... 

Article 6 of the RoHS Directive (recast 2011 [9]) says 1. With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and amendment of the list of restricted substances in Annex II shall be considered by the Commission before 22 July 2014, and periodically thereafter on its own initiative or following the submission of a proposal by a Member State. .. . 

The use of DMF in biocidal products was prohibited in the EU according to EU Directive 98/8/EC [15]. However, the directive did not restrict the import of articles treated with DMF into the EU. As a consequence, the European Union made a temporary restriction to place products containing DMF on the market in 2009 (Decision 2009/251/EC). The restriction was on 15 May 2012 made permanent by the EC Regulation 412/2012 amending Annex XVII to EC Regulation 1907/2006 (REACH) [12]. The text in REACH states that articles or any parts thereof in concentrations greater than 0.1 mg/kg shall not be placed on the market. 

European Commission (2009) Regulation No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction (REACH) as regards Annex XVII... 

Further information must be submitted after the amount of substance supphed to the EU reaches the Level 1 and Level 2 trigger points and the possible studies are given in Annex VIII of the Seventh Amendment. Some Level 1 testing may be required at 10 tonnes per annum (or 50 tonnes cumulative), but will definitely be required in full at 100 tonnes annually (or 500 tonnes cumulative). 

Articles 5-8 and Annexes VII and VIII in the Sixth Amendment ) contain the key provisions of the EEC s premarket notification program. Articles 2, 9-13, and 20-23 also are particularly relevant. 

Both the Sixth Amendment and several national premarket laws and regulations authorize individual Member States to (1) contest companies claims that certain data (in the Annex VII base set) are not necessary or are not technologically possible (2) to require the development of additional information and data and (3) to impose production or use restrictions pending the development of such additional data. Further, EEC countries may act without having to follow many of the procedures that TSCA imposes upon EPA, and the findings necessary to take these actions appear to be less stringent than TSCA requires of the Agency. 

Article 6(1) of the Sixth Amendment requires PMN s to contain information and data necessary for evaluating the potential risks of new substances to humans and the environment. This specifically includes certain exposure information listed in Annex VII, concerning proposed uses and estimated yearly production volumes (in ranges, and broken down by use categories). Further, Article 6(1) requires submission of "a declaration concerning the unfavourable effects of the substance in terms of the various uses envisaged," which appears to require statements of the risks that may be associated with the use categories provided under Annex VII.(26)... 

The changes to the London Protocol also led to a revision of the OSPAR Convention for the Protection of the Marine Environment of the North-East Atlantic, which is the North-East Atlantic s version of the London Protocol, and which combines the 1972 Oslo Convention on dumping waste at sea and the 1974 Paris Convention on land-based sources of marine pollution. In 2007, the OSPAR Convention also adopted amendments to the Annexes to the Convention to allow the storage of C02 in geological formations under the seabed (www.ospar.org). 

Amending Directive 2001/5/EC contains several new authorisations including the addition of E 949 hydrogen to annex I, and E 943a butane, E 943b iso-butane and E 944 propane to annex IV for use as vegetable oil pan sprays (professional use only) and as water-based emulsion sprays, quantum satis. E 650 zinc acetate is also added to annex IV for use in chewing gum, max. 1000 mg/kg. 

The annex to Directive 84/344/EEC, as amended, which contains the technical details, includes three lists of extraction solvents allowed for food processing ... 

Annex II lists all those materials and components that are exempt from 4(2) (a). Eor example lead as an element (i.e. steel upto 0.35% lead by weight, aluminium, copper), lead compounds in components (i.e. batteries, petrol tank coatings, vibration dampers, stabilisers in protective paint), hexavalent chromium (used as coating on various key vehicle components) and mercury (as can be found in bulbs and instrument panel displays). As ruled in 4(2) (b), the Commission shall regularly amend Annex II, i.e. review all substances that are currently exempt from 4(2) (a). If the use of any of the materials or compounds listed in Annex II can be avoided, those substances will be deleted from this Annex. 

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. 

One thing that has been added to the amendment is clear expiry dates for the exemption of about half of those materials and components listed in Annex II. A lot of those expiration DA dates apply to the exempt status for lead compounds in vehicles. 

The basic requirements for the contents of the dossier of information accompan)dng the application for a marketing authorisation are the same whether it is submitted nationally or centrally and were laid out in detail in Directive 715/318/EEC and its subsequent amendments. These requirements were included as Annex 1 of the codified Directive 2001/83/EC. 

The types of product that fell within the scope of Council Regulation (EEC) No. 2309/93 as amended, were set out in the Annex to that Regulation. Eor medicinal products falling within the scope of Part A of the Annex, applicants were obliged to use the centralised procedure and send their application to the EMEA. Eor those falling within the scope of Part B of the Annex, applicants may, at their discretion, also use the centralised procedure. Unlike the previous concertation procedure (Council Directive... 

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