Article 2 ApplicationX1

radioactive substances within the scope of F1F2assimilated law that transposed Council Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation;

substances, on their own, in a F3mixture or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;

non-isolated intermediates;

the carriage of dangerous substances and dangerous substances in dangerous mixtures by rail, road, inland waterway, sea or air.

in paragraph 1, “Member States shall take appropriate measures to ensure that” were omitted;

after paragraph 1 there were inserted—

“1A.

Any decision as to whether a substance or object is a by-product must be made—

(a)

in accordance with any regulations setting out detailed criteria on the application of the conditions in paragraph 1 to specific substances or objects; and

(b)

having regard to any guidance published by the appropriate authority or the appropriate agency for the purposes of this Article.” ;

paragraphs 2 and 3 were omitted.

in paragraph 1, “Member States shall take appropriate measures to ensure that” were omitted;

after paragraph 1 there were inserted—

“1A.

Any decision as to whether a substance or object has ceased to be waste must be made—

(a)

in accordance with any regulations or F6assimilated direct legislation setting out detailed criteria on the application of the conditions in paragraph 1 to specific types of waste; and

(b)

having regard to any guidance published by the appropriate authority or the appropriate agency for the purposes of this Article.” ;

in paragraph 2—

paragraph 3 were omitted;

in paragraph 4—

the Environment Agency, in relation to England;

the Natural Resources Body for Wales, in relation to Wales;

the Scottish Environment Protection Agency, in relation to Scotland.

in medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013, or the Human Medicines Regulations 2012;

in food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:

1. (i)

   F10as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;

2. (ii)

   F11as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods F12...;

3. (iii)

   as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition ^f2;

4. (iv)

   F13in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009 .

medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013, or the Human Medicines Regulations 2012;

cosmetic products as defined in Regulation (EC) No 1223/2009 on cosmetic products;

medical devices which are invasive or used in direct physical contact with the human body in so far as legislation relating to the classification and labelling of dangerous substances and mixtures applies to them which ensures the same level of information provision and protection as Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures;

food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:

1. (i)

   F17as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;

2. (ii)

   as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods F18...;

3. (iii)

   as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;

4. (iv)

   F19in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009 .

substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties;

substances covered by Annex V, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation;

substances on their own or in mixtures, registered in accordance with Title II, exported F20from Great Britain by an actor in the supply chain and re-imported F21into Great Britain by the same or another actor in the same supply chain who shows that:

1. (i)

   the substance being re-imported is the same as the exported substance;

2. (ii)

   he has been provided with the information in accordance with Articles 31 or 32 relating to the exported substance;

substances, on their own, in mixtures or in articles, which have been registered in accordance with Title II and which are recovered in F22Great Britain if:

1. (i)

   the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and

2. (ii)

   the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery.

Chapter 1 of Title II, with the exception of Articles 8 and 9; and

Title VII.