text:
PART 1
Preliminary
Title, application and commencement
1
These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (England) Regulations 2006, apply in relation to England only and come into force on 30th June 2006.
Interpretation
2
1
In these Regulations —
“ the Act ” means the Food Safety Act 1990;
“authorised officer” means any person, whether or not an officer of the enforcement authority, who is authorised by it in writing to act in matters arising under these Regulations;
“BADGE” has the meaning given in Article 1(1)(a) of Regulation 1895/2005 ;
“ BFDGE ” has the meaning given in Article 1(1)(b) of Regulation 1895/2005;
“business” is to be construed in accordance with section 1(3) of the Act;
“capable” means capable as established under regulation 11;
“ Directive 82/711 ” means Council Directive 82/711/ EEC laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, as last amended by Commission Directive 97/48/EC ;
“ Directive 85/572 ” means Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs ;
“ Directive 88/388 ” means Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production ;
“ Directive 89/107 ” means Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised in foodstuffs intended for human consumption ;
“ the Directive ” means Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs, as last amended by Commission Directive 2004/19/EC ;
“ EEA State” means a Member State (other than the United Kingdom), Norway, Iceland and Liechtenstein;
“ EFSA ” means the European Food Safety Authority;
“enforcement authority” means an authority having responsibility under regulation 14 for executing and enforcing these Regulations;
“food” is to be construed in accordance with section 16(5) of the Act;
“good technical quality” means good technical quality as regards the purity criteria;
“handling of food” means use in connection with the storage, preparation, packaging, sale or serving of food;
“import” means import in the course of a business;
“material or article” means a material or article falling within the definition of materials and articles in Article 1(2) of Regulation 1895/2005;
“monomer” means any substance that is included for the purposes of the Directive among monomers and other starting substances;
“ NOGE ” has the meaning given in Article 1(1)(c) of Regulation 1895/2005;
“the 1998 Regulations ” means the Plastic Materials and Articles in Contact with Food Regulations 1998 ;
“the 2005 Regulations ” means the Materials and Articles in Contact with Food (England) Regulations 2005 ;
“plastic material or article” means anything which for the purposes of the Directive is included among those plastic materials and articles and parts thereof to which the Directive applies;
“the Purity Directives ” means Commission Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs , Commission Directive 95/45/EC laying down purity criteria concerning colours for use in foodstuffs and Commission Directive 96/77/EC laying down specific purity criteria for food additives other than colours or sweeteners ;
“Regulation 1895/2005” means Commission Regulation (EC) No 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food ;
“sell” includes offer or expose for sale or have in possession for sale, and “sale” shall be construed accordingly;
2
For the purposes of these Regulations the supply otherwise than on sale, in the course of a business, of any material or article is deemed to be a sale.
3
Any other expression used in these Regulations and in the Directive, Directive 82/711, Directive 85/572 or Regulation 1895/2005 bears the same meaning in these Regulations as it bears in that Directive or Regulation.
PART 2
Requirements for Materials and Articles
Restriction on the use, sale or import of plastic materials and articles
3
1
No person may —
a
use for the handling of food in the course of a business;
b
sell for the purpose of handling of food; or
c
import from anywhere other than an EEA State for the purpose of handling of food,
a plastic material or article which fails to meet the required standard.
2
For the purposes of this regulation a plastic material or article fails to meet the required standard if —
a
it has been manufactured with a prohibited monomer as described in regulation 4(2) or a prohibited additive as described in regulation 5(2); or
b
it does not meet the required standards set out in regulation 6, 7, 8, 9 or 10.
Restriction on the use of monomers in the manufacture of plastic materials and articles
4
1
Subject to paragraphs (3), (4) and (5), no person may use any prohibited monomer in the manufacture of any plastic material or article.
2
A prohibited monomer is any monomer which is not —
a
of good technical quality;
b
identified by PM/REF No, CAS No (if any) and name in columns 1, 2 and 3 respectively of the relevant section of Part 1 of Schedule 1; and
c
used in accordance with any restrictions and specifications for that monomer set out or referred to in column 4 of that section.
3
Paragraph (1) does not apply to the use of a monomer in the manufacture of any —
a
surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, including but not limited to varnishes, lacquers and paints;
b
epoxy resins;
c
adhesives and adhesion promoters; or
d
printing inks.
4
Paragraph (1) shall not be taken to prohibit the manufacture of any plastic material or article with any substance if the substance in question is a mixture which falls within paragraph 3(c) (relating to mixtures of authorised substances) of Annex II to the Directive and is of good technical quality.
5
In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with paragraph (1) because it was manufactured with any monomer (whether or not of good technical quality) other than one mentioned in paragraph (2)(b) it shall be a defence for the person accused to prove that —
a
each monomer is present in the finished plastic material as an impurity, a reaction intermediate or a decomposition product which falls within paragraph 3(a) of Annex II to the Directive, or
b
each such monomer is an oligomer or a natural or synthetic macromolecular substance or a mixture thereof which falls within paragraph 3(b) of that Annex,
and is of good technical quality.
6
Part 2 of Schedule 1 has effect to supplement this regulation and Part 1 of that Schedule.
Restriction on the use of additives in the manufacture of plastic materials and articles
5
1
Subject to paragraph (3) no person may use in the manufacture of any plastic material or article any prohibited additive.
2
A prohibited additive is —
a
any additive identified by PM/REF No, CAS No (if any) and name in columns 1, 2 and 3 respectively of Part 1 or Part 2 of Schedule 2 which —
i
is not of good technical quality, or
ii
is not used in accordance with any restrictions and specifications for that additive set out in the corresponding entry in column 4 of Part 1 or Part 2 of that Schedule; or
b
any food additive authorised by Directive 89/107 or any flavouring authorised by Directive 88/388 that migrates into food —
i
in a quantity that has a technological function in the final food product, or
ii
where the food is of a type for which the use of any such food additive or flavouring is so authorised, in quantities exceeding the limits provided for in Directive 89/107 or Directive 88/388 as appropriate, or in Schedule 2, whichever is the lower.
3
In any proceedings for an offence under these Regulations where it is alleged that the commission of the offence is due to the manufacture of a plastic material or article with any additive identified in Part 1 or Part 2 of Schedule 2 which is not of good technical quality, it shall be a defence for the person accused to prove that each such additive is present in the finished plastic material or article as an impurity, a reaction intermediate or a decomposition product.
4
Part 3 of Schedule 2 has effect to supplement this regulation and Parts 1 and 2 of that Schedule.
Required standard for non-migration of constituents of monomers
6
1
Subject to paragraph (2), where a migration limit expressed in mg/ kg is indicated in column 4 of the relevant section of Part 1 of Schedule 1 in relation to any monomer, a plastic material or article manufactured from that monomer meets the required standard under this regulation if it is not capable of transferring constituents of that monomer to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit, and for the purposes of this paragraph the appropriate limit is —
a
the number of milligrams expressed in column 4 released per kilogram of food in the case of any plastic material or article other than one specified in sub-paragraph (b); and
b
one sixth of the number of milligrams expressed in column 4 per square decimetre of surface area of the plastic material or article if the plastic material or article comprises —
i
an article which is a container or is comparable to a container or can be filled, having a capacity of less than 500 millilitres or more than 10 litres, or
ii
sheet, film or other plastic material or article which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of the material or article in question and the quantity of food in contact with that surface area.
2
A plastic material or article manufactured from any monomer for which a migration limit in mg/kg is expressed in column 4 of the relevant section of Part 1 of Schedule 1 is not deemed to be capable of transferring constituents of that monomer to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (1) if the only food with which that plastic material or article may come into contact is food to which regulation 9(3) applies.
Required standard for non-migration of constituents of additives
7
1
Subject to paragraph (2), where a migration limit expressed in mg/kg is indicated in column 4 of Part 1 or 2 of Schedule 2 in relation to any additive, a plastic material or article manufactured containing that additive meets the required standard under this regulation if it is not capable of transferring constituents of that additive to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit, and for the purposes of this paragraph the appropriate limit is —
a
the number of milligrams indicated in column 4 released per kilogram of food in the case of any plastic material or article other than one specified in sub-paragraph (b); and
b
one sixth of the number of milligrams expressed in column 4 per square decimetre of surface area of the plastic material or article if the plastic material or article comprises —
i
an article which is a container or is comparable to a container or can be filled, having a capacity of less than 500 millilitres or more than 10 litres, or
ii
sheet, film or other plastic material or article which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of the material or article in question and the quantity of food in contact with that surface area.
2
A plastic material or article manufactured containing an additive for which a migration limit in mg/kg is expressed in column 4 of Part 1 or Part 2 of Schedule 2 is not deemed to be capable of transferring constituents of that additive to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (1) if the only food with which that plastic material or article may come into contact is food to which regulation 9(3) applies.
Required standard for products obtained by bacterial fermentation
8
A product obtained by bacterial fermentation meets the required standard under this regulation if it is —
a
of good technical quality;
b
identified by PM/REF No, CAS No and name in columns 1, 2 and 3 respectively of Schedule 3: and
c
in compliance with the restrictions and specifications set out in column 4 of that Schedule.
Required standards relating to overall migration limits
9
1
Subject to paragraph (3), a plastic material or article meets the required standard under this regulation if it is not capable of transferring its constituents to food with which it may come into contact in quantities exceeding the appropriate limit specified in paragraph (2).
2
a
In the case of any plastic material or article comprising —
i
an article which is a container or comparable to a container or can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres,
ii
an article which can be filled and for which it is impracticable to estimate the surface area in contact with food, or
iii
a cap, gasket, stopper or similar device for sealing,
the appropriate limit is an overall migration limit of 60 milligrams of constituents released per kilogram of food.
b
In the case of any other plastic material or article, the appropriate limit is an overall migration limit of 10 milligrams per square decimetre of the surface area of the plastic material or article.
3
For the purposes of this regulation a plastic material or article is not deemed to fail to meet the required standard under paragraph (1) if the only food with which that material or article may come into contact is food —
a
which is specified in the table to Part 4 of Schedule 6; and
b
where there is no “X” placed anywhere in the group of columns headed “Simulants to be used” opposite that food.
4
In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with this regulation, the defences available in paragraph 6(2) and 7(2) of Schedule 5 shall be available as specified in those paragraphs.
Required standard for non-migration of primary aromatic amines
10
1
Subject to paragraph (3), a plastic material or article manufactured using isocyanates or colourants prepared by diazo-coupling meets the required standard under this regulation if it is not capable of transferring in a detectable quantity primary aromatic amines (expressed as aniline), not being primary aromatic amines listed in these Regulations, to food with which that plastic material or article may come into contact.
2
Schedule 4 has effect for the purpose of prescribing, for certain items listed in Part 1 of Schedule 1, Part 1 or 2 of Schedule 2, or Schedule 3, the specifications for those items that are referred to in column 4 of the Part or Schedule concerned.
3
In paragraph (1) a detectable quantity means a quantity which can be determined with an analytical method capable of achieving a detection limit of at least 0.02 milligrams per kilogram of food or food simulant (including analytical tolerance).
Method of testing the capability of plastic materials or articles to transfer constituents, and methods of analysis
11
1
A plastic material or article shall be treated as capable of transferring constituents to food with which it may come into contact to the extent that such capability is established —
a
in any case other than one to which sub-paragraph (b) applies, and subject to Article 8.4 of the Directive (which may be applied on compliance with the conditions stated therein), by the verification methods specified in Schedule 5 (including the analytical tolerances referred to in paragraph 8 of that Schedule) and Schedule 6;
b
in any case where the extent to which vinyl chloride, as identified in Part 1 of Schedule 1, is capable of such transfer falls to be established, by the method referred to in regulation 7(2) of the 2005 Regulations.
2
In Schedules 5 and 6, references to migration or release of a substance are to be construed as references to the transfer of constituents to the simulant representing the food or, as the case may be, food with which it may come into contact.
3
The specific migration of a constituent from a plastic material or article shall where applicable be determined in the manner specified in the relevant sub-paragraph of paragraph 8 of Annex II to the Directive.
4
The quantity of a constituent in a plastic material or article shall where applicable be determined in the manner specified in the sub-paragraph of paragraph 8 of Annex II to the Directive relating to the term “QM(T)”, “QMA” or “QMA(T)” as the case may be.
Labelling
12
1
At marketing stages other than the retail stage a person who is in possession of any plastic material or article must ensure that the plastic material or article is accompanied by a written declaration which —
a
accords with the requirements of Article 16(1) of Regulation (EC) No. 1935/2004 of the European Parliament and of the Council ; and
b
provides, in respect of substances that are subject to a restriction on quantities migrating into food, information obtained from experimental data or theoretical calculation concerning —
i
the levels of migration specific to those substances;
ii
where appropriate, purity criteria in accordance with the purity Directives.
2
In establishing which descriptions of food a material or article may come into contact with, it is to be assumed until the contrary is proved that, for the purposes of these Regulations, if particulars are shown in relation to that material or article in accordance with paragraph (1)(a), those particulars are accurate and that unless the particulars so indicate, there are no restrictions on the intended conditions of contact.
Provisions relating to the use of certain epoxy derivatives (BADGE, BFDGE and NOGE)
13
1
In this regulation —
a
any reference to a numbered Article is a reference to that Article in Regulation1895/2005;
b
paragraphs (2) to (5) are subject to Article 1(3) (exception relating to certain storage containers and pipelines);
c
for the purpose of Article 6(4) the competent authority is the authority identified in regulation 14.
2
Subject to Article 6(1), (2) (transitional provisions) and (4) (labelling requirements), no person may —
a
manufacture,
b
use for the handling of food in the course of a business,
c
sell for the purpose of the handling of food, or
d
import for the purpose of the handling of food
any material or article in contravention of Article 3 or Article 4 (prohibitions relating to BFDGE and NOGE respectively).
3
No person may manufacture any material or article in such a way as to contravene the requirements of Article 2 (controls on the migration of BADGE from materials and articles).
4
Subject to Article 6(1), no person may —
a
use for the handling of food in the course of a business,
b
sell for the purpose of the handling of food, or
c
import for the purpose of the handling of food
any material or article that has been manufactured in such a way as to contravene the requirements of Article 2.
5
Subject to Article 6(3) (transitional provisions relating to materials and articles brought into contact with food before 1st January 2007), no person shall contravene or fail to comply with the requirements of Article 5 (obligations regarding the provision of a written statement when marketing materials or articles containing BADGE or its derivatives).
6
No person shall without reasonable excuse fail to comply with a request made under Article 6(4) (requirement to disclose date of filling to competent authority).
PART 3
Execution and Enforcement
Enforcement
14
Each food authority in its area and each port health authority in its district shall execute and enforce —
a
the provisions of Regulation 1895/2005 mentioned in regulation 13, and
b
these Regulations.
Offences and Penalties
15
1
Any person who —
a
contravenes or fails to comply with regulation 3(1), 4(1), 5(1), 12(1) or 13(2) to (5);
b
intentionally obstructs any person acting in the execution of Regulation 1895/2005 or these Regulations;
c
contravenes regulation 13(6) or, without reasonable excuse, otherwise fails to give to any person acting in the execution of Regulation 1895/2005 or these Regulations any assistance or information which that person may reasonably require; or
d
in purported compliance with any requirement mentioned in sub-paragraph (c), knowingly or recklessly supplies information that is false or misleading in any material particular,
is guilty of an offence.
2
Anyone convicted of an offence under these Regulations is liable —
a
in the case of an offence under paragraph (1)(a) —
i
on conviction on indictment to a term of imprisonment not exceeding two years or to a fine or both;
ii
on summary conviction to a term of imprisonment not exceeding six months or to a fine not exceeding the statutory maximum or both;
b
in the case of any other offence under these Regulations to a term of imprisonment not exceeding three months or to a fine not exceeding level five on the standard scale or both.
3
Nothing in paragraph (1)(c) is to be construed as requiring any person to answer any question or give any information if to do so might incriminate him.
4
Where an offence under these Regulations which has been committed by a body corporate or a Scottish partnership is proved to have been committed with the consent or connivance of or to be attributable to any neglect on the part of —
a
any director, manager, secretary or other similar officer of the body corporate or any partner of the Scottish partnership, or
b
any person purporting to act in such a capacity,
he as well as the body corporate or, as the case may be, the Scottish partnership shall be deemed to be guilty of that offence and liable to be proceeded against and punished accordingly.
5
No prosecution for an offence under these Regulations shall be begun after the expiry of three years from the commission of the offence or one year from its discovery by the prosecutor, whichever is the earlier.
6
Where the commission by any person of an offence under these Regulations is due to the act or default of some other person, that other person shall also be guilty of the offence; and a person may be charged with and convicted of the offence whether or not proceedings are taken against the first mentioned person.
General defences
16
1
In any proceedings for an offence under these Regulations it shall, subject to paragraph (5), be a defence for the person accused to prove that he took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by himself or by a person under his control.
2
Without prejudice to the generality of paragraph (1), a person accused of an offence under these Regulations who did not —
a
prepare the plastic material or article or, as the case may be, the material or article in respect of which the offence is alleged to have been committed; nor
b
import it into the United Kingdom,
shall be taken to have established the defence provided by paragraph (1) if he satisfies the requirements of paragraphs (3) and (4).
3
A person satisfies the requirements of this paragraph if he proves —
a
that the commission of the offence was due to the act or default of some other person who was not under his control, or to reliance on information supplied by such a person;
b
that either —
i
he carried out all such checks of the plastic material or article or material or article in question as were reasonable in all the circumstances, or
ii
it was reasonable in all the circumstances for him to rely on checks carried out by the person who supplied him with the plastic material or article or the material or article in question; and
c
that he did not know and had no reason to suspect at the time the offence was committed that his act or omission would amount to an offence under these Regulations.
4
A person satisfies the requirements of this paragraph if the offence is one of sale and he proves —
a
that the commission of the offence was due to the act or default of some other person who was not under his control, or to reasonable reliance on information supplied by such a person;
b
that the sale of which the alleged offence consisted was not a sale under his name or mark; and
c
that he did not know and could not reasonably have been expected to know at the time the offence was committed that his act or omission would amount to an offence under these Regulations.
5
If in any case the defence provided by this regulation involves the allegation that the commission of the offence was due to the act or default of another person, or to reliance on information supplied by another person, the person accused shall not without leave of the court be entitled to rely on that defence unless —
a
at least seven clear days before the hearing; and
b
where he has previously appeared before the court in connection with the alleged offence, within one month of his first such appearance,
he has served on the prosecutor a written notice giving such information identifying or assisting in the identification of that other person as was then in his possession.
Transitional defences and savings
17
Not withstanding the revocations made in regulation 24, in relation to any plastic material or article —
a
manufactured before the 1st July 1998, the defence in regulation 3(3) of the 1998 Regulations;
b
manufactured or imported into the European Community before 1st January 2003, the defence in regulation 10(15) of the 1998 Regulations;
c
put into free circulation in the European Community before 30th November 2002, the defence in regulation 10(16) of the 1998 Regulations;
d
manufactured or imported into the European Community before 1st March 2004, the defence in regulation 10(21)(a) of the 1998 Regulations;
e
manufactured or imported into the European Community before 1st March 2003, the defence in regulation 10(21)(b) of the 1998 Regulations;
f
containing azodicarbonamide and brought into contact with food before 2nd August 2005, the defence in regulation 10(23) of the 1998 Regulations; or
g
manufactured or imported into the European Community before 1st March 2006, the defence in regulation 10(25) of the 1998 Regulations,
shall apply in relation to offences under these Regulations in like manner as it applied to offences under the equivalent provisions in those Regulations.
Procedure where a sample is to be analysed
18
1
An authorised officer who has procured a sample under section 29 of the Act and who considers it should be analysed shall divide the sample into three parts.
2
If the sample consists of sealed containers and opening them would, in the opinion of the authorised officer, impede a proper analysis, the authorised officer shall divide the sample into parts by putting the containers into three lots, and each lot shall be treated as being a part.
3
The authorised officer shall —
a
if necessary place each part in a suitable container and seal it;
b
mark each part or container;
c
as soon as reasonably practicable, give one part to the owner and notify him in writing that the sample will be analysed;
d
submit one part for analysis in accordance with section 30 of the Act; and
e
retain one part for future submission under regulation 19.
Secondary analysis by the Government Chemist
19
1
Where a sample has been retained under regulation 18 and —
a
proceedings are intended to be or have been commenced against a person for an offence under these Regulations; and
b
the prosecution intends to adduce as evidence the result of the analysis mentioned above,
paragraphs (2) to (7) apply.
2
The authorised officer —
a
may of his own volition;
b
shall if requested by the prosecutor (if a person other than the authorised officer);
c
shall if the court so orders; or
d
shall (subject to paragraph (6)) if requested by the defendant,
send the retained part of the sample to the Government Chemist for analysis.
3
The Government Chemist shall analyse the part sent to him under paragraph (2) and send to the authorised officer a certificate of analysis.
4
Any certificate of the results of testing transmitted by the Government Chemist under this regulation shall be signed by or on behalf of him, but the testing may be carried out by any person under the direction of the person who signs the certificate.
5
The authorised officer shall immediately on receipt supply the prosecutor (if a person other than the authorised officer) and the defendant with a copy of the Government Chemist’s certificate of analysis.
6
Where a request is made under paragraph (2)(d) the authorised officer may give notice in writing to the defendant requesting payment of a fee specified in the notice to defray some or all of the Government Chemist’s charges for performing the functions under paragraph (3), and in the absence of agreement by the defendant to pay the fee specified in the notice the authorised officer may refuse to comply with the request.
7
In this regulation “defendant” includes a prospective defendant.
PART 4
Application for Authorisation
Applications for inclusion of an additive in the Community list of authorised additives
20
1
This regulation applies where a person wishes to make an application for the inclusion of an eligible additive in the Community list referred to in Article 4 of the Directive.
2
The application mentioned in paragraph (1), including supporting data, must be made to EFSA before 1st January 2007.
3
If during examination of the data referred to in paragraph (2), EFSA calls for supplementary information, the eligible additive may, if otherwise permitted to be used under English law, continue to be so used until EFSA has issued an opinion, provided the supplementary opinion is submitted within the time limits specified by EFSA.
4
For the purposes of this regulation, an eligible additive is one whose use is permitted in one or more Member States before 1st January 2007.
PART 5
General and Supplementary
Application of provisions of the Act
21
The following provisions of the Act shall apply for the purposes of these Regulations as they apply for the purposes of the Act —
a
section 3 (presumption that food is intended for human consumption);
b
section 30(8) (relating to documentary evidence);
c
section 36 (offences by bodies corporate);
d
section 36A (offences by Scottish partnerships);
e
section 44 (protection of officers acting in good faith).
Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990
22
In the Food Safety (Sampling and Qualifications) Regulations 1990 , in Schedule 1 (provisions to which those Regulations do not apply) for the title and reference of the 1998 Regulations substitute the title and reference of these Regulations.
Amendments to the Materials and Articles in Contact with Food (England) Regulations 2005
23
1
The 2005 Regulations are amended in accordance with paragraphs (2) to (6).
2
In regulation 2(1) —
a
omit the definition of “the 1998 Regulations”;
b
after the definition of “sell” add the following definition —
”the 2006 Regulations ” means the Plastic Materials and Articles in Contact with Food (England) Regulations 2006 .
3
In regulation 8(4), for the expression “Schedules 1, 2 or 2A to the 1998 Regulations” substitute “Schedules 1, 2 or 3 to the 2006 Regulations”.
4
In regulation 9(3) —
a
for the expression “Part I of Schedule 1 to the 1998 Regulations” substitute “Part 1 of Schedule 1 to the 2006 Regulations”; and
b
in sub-paragraph (b) for “Part II” substitute “Part 2”.
5
In regulation 9(5), for the expression “Schedules 3 and 4 of the 1998 Regulations as read with regulation 6 of those Regulations” substitute “Schedules 5 and 6 of the 2006 Regulations as read with regulation 11 of those Regulations”.
6
In regulation 10(2), for the expression “proceedings for an offence under regulation” substitute “proceedings for an offence of contravening regulation”.
Revocations
24
The following Regulations or parts thereof are revoked —
a
the 1998 Regulations in so far as they apply in relation to England;
b
the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000 ;
c
the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2002 ;
d
the Plastic Materials and Articles in Contact with Food (Amendment) (England) (No.2) Regulations 2002 ;
e
the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2004 ;
f
the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 ;
g
regulation 15 of the 2005 Regulations.
Signed by authority of the Secretary of State for Health
Caroline Flint
Minister of State,
Department of Health
23rd May 2006


type: legislation

jurisdiction: UK

text:
Citation and commencement
1
These Regulations may be cited as the Employer-Financed Retirement Benefits (Excluded Benefits for Tax Purposes) Regulations 2006 and come into force on 6th April 2006.
Excluded benefit
2
1
For the purposes of section 393B(3)(d) of the Income Tax (Earnings and Pensions) Act 2003 (prescribed benefits to be excluded benefits for the purpose of Chapter 2 of Part 6 of that Act) a lump sum benefit which is —
a
in respect of the non-accidental death of an employee during service, and
b
already provided for under the rules of a scheme on 6 th April 2006,
is prescribed.
2
In paragraph (1) “scheme” means any scheme which, on 6th April 2006 —
a
will be an employer–financed retirement benefits scheme, or
b
would be such a scheme but for the fact that it provides for a benefit which is an excluded benefit by virtue of this regulation.
3
In paragraph (2) “employer–financed retirement benefits scheme” has the meaning given in section 393A of the Income Tax (Earnings and Pensions) Act 2003.
David Varney
Mike Hanson
Two of the Commissioners for Her Majesty’s Revenue and Customs
1st February 2006


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the NHS Blood and Transplant (Gwaed a Thrawsblaniadau'r GIG) (Amendment) Regulations 2006 and shall come into force on 1 st April 2006.
2
In these Regulations “the principal Regulations ” means the NHS Blood and Transplant (Gwaed a Thrawsblaniadau'r GIG) Regulations 2005 .
Amendment of regulation 1 of the principal Regulations
2
In regulation 1(2) of the principal Regulations (citation, commencement and interpretation), at the appropriate alphabetical place, insert —
“sentence of imprisonment” does not include a committal —
in default of payment of any sum of money,
for want of sufficient distress to satisfy any sum of money, or
for failure to do or abstain from doing anything required to be done or left undone;
.
Amendment of regulation 2 of the principal Regulations
3
In regulation 2 of the principal Regulations (appointment and tenure of office of chairman and members), after paragraph (4) insert —
4A
Where for any period the chief executive is suspended from his duties as a chief executive of the Authority —
a
he shall also be suspended for that period from performing his functions as a member, and
b
any person appointed to act in his place as chief executive shall also be appointed to perform his functions as a member of the Authority for that period.
.
Amendment of regulation 3 of the principal Regulations
4
In regulation 3(1) of the principal Regulations (disqualification for appointment), for paragraph (a) substitute —
a
he has, within the preceding five years —
i
been convicted in the United Kingdom of any offence or been convicted elsewhere of any offence which, if committed in any part of the United Kingdom would constitute a criminal offence; and
ii
been sentenced to a sentence of imprisonment (whether suspended or not); and
iii
neither the conviction has been quashed nor the sentence reduced to a sentence other than a sentence of imprisonment (whether suspended or not) on appeal.
.
Amendment of regulation 4 of the principal Regulations
5
In regulation 4(1) of the principal Regulations (cessation of disqualification) omit “(i) or (iii)”.
Signed by authority of the Secretary of State for Health
Rosie Winterton
Minister of State,
Department of Health
9th March 2006
Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998
D. Elis-Thomas
The Presiding Officer of the National Assembly, National Assembly for Wales
8th March 2006


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006.
2
These Regulations shall come into force on 1st September 2006.
3
In these Regulations, “the Marketing Authorisation Regulations ” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 .
Amendment of regulation 1 of the Marketing Authorisation Regulations
2
In regulation 1 of the Marketing Authorisation Regulations (citation, commencement and interpretation) —
a
in paragraph (2), after the definition of “first level nurse”, insert the following definition —
“national homoeopathic product” has the meaning given in regulation 4(1B);
; and
b
after paragraph (7), insert the following paragraph —
8
In these Regulations, in relation to a national homoeopathic product, any reference to the relevant Community provisions is to be read as a reference to those provisions as if —
a
in Articles 19(1), 26 and 116 of the 2001 Directive , any reference to Article 8 is a reference to —
i
Article 8, except the second and third indents of paragraph 3(i) of that Article, and
ii
Parts 2 and 3 of Schedule 1A to these Regulations;
b
in Article 21(4) of the 2001 Directive, the reference to the results of the pre-clinical tests and the clinical trials of the medicinal product concerned is a reference to the particulars and documents submitted pursuant to Parts 2 and 3 of Schedule 1A to these Regulations in relation to the medicinal product concerned; and
c
in Article 23 of the 2001 Directive, the reference to Articles 8(3), 10, 10a, 10b and 11, or 32(5), or Annex I is a reference to —
i
Article 8(3), except the second and third indents of Article 8.3(i),
ii
Articles 10, 10a, 10b and 11,
iii
Annex I, other than the provisions set out in paragraph 2(1) of Schedule 1A to these Regulations, or
iv
Parts 2 and 3 of Schedule 1A to these Regulations.
.
Amendment of regulation 4 of the Marketing Authorisation Regulations
3
1
Regulation 4 of the Marketing Authorisation Regulations (applications for the grant, renewal or variation of a United Kingdom marketing authorization) is amended as follows.
2
In paragraph (1), after “parallel imports” insert “and paragraph (1A)”.
3
After paragraph (1), insert the following paragraphs —
1A
Schedule 1A shall have effect in relation to applications for the grant of a United Kingdom marketing authorization for a national homoeopathic product.
1B
A national homoeopathic product is a homoeopathic medicinal product which —
a
does not satisfy the conditions set out in article 14(1) of the 2001 Directive; and
b
is indicated for the relief or treatment of minor symptoms or minor conditions in humans.
1C
For the purposes of paragraph (1B), symptoms or conditions are minor if they can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor.
.
Provisions relating to applications for national homoeopathic products
4
After Schedule 1 to the Marketing Authorisation Regulations, insert the following Schedule —
SCHEDULE 1A
APPLICATION FOR GRANT OF MARKETING AUTHORIZATION FOR NATIONAL HOMOEOPATHIC PRODUCT
Regulation 4(1A)
PART 1
GENERAL
1
1
An application for the grant of a United Kingdom marketing authorization for a national homoeopathic product is not required to be made in accordance with, and the applicant for such an authorization is not required to comply with —
a
the second and third indents of Article 8.3(i) of the 2001 Directive (the requirement to submit the results of pre-clinical tests and clinical trials); and
b
the provisions of Part I of Annex I to that Directive set out in paragraph 2(1).
2
But the applicant must submit with his application particulars and documents relating to —
a
the safety of the medicinal product to which the application relates, in accordance with Part 2 of this Schedule; and
b
the efficacy of that product, in accordance with Part 3 of this Schedule.
3
The last sub-paragraph of Article 8.3 of the 2001 Directive applies to an application referred to in sub-paragraph (1) as if the reference to the results of pre-clinical tests and clinical trials referred to in point (i) of Article 8.3 were a reference to the safety and efficacy data provided pursuant to Parts 2 and 3.
2
1
The provisions of Part I of Annex I to the 2001 Directive referred to in paragraph 1(1) are —
a
sections 2.4 to 2.7 (non-clinical and clinical overview and non-clinical and clinical summaries);
b
section 4 (Module 4: non-clinical reports); and
c
section 5 (Module 5: clinical study reports).
2
The applicant must submit —
a
the particulars and documents required by Part 2 of this Schedule in place of Module 4 of the particulars and documents accompanying his application, and
b
the particulars and documents required by Part 3 of this Schedule in place of Module 5 of the particulars and documents accompanying his application.
3
References in Annex I to the 2001 Directive, in provisions other than those referred to in sub-paragraph (1), to —
a
non-clinical reports, non-clinical documentation and non-clinical data, and
b
clinical study reports, clinical documentation and clinical data,
shall apply in relation to such an application as if they were references to the particulars and documents referred to in sub-paragraphs (2)(a) and (b), respectively.
4
An application for the grant of a United Kingdom marketing authorization for a national homoeopathic product is not required to be made in accordance with, and the applicant for such an authorization is not required to comply with, the guidance referred to in paragraph (1) of Annex I (in the section headed “Introduction and general principles”), insofar as that guidance relates to the requirement to submit the results of pre-clinical tests and clinical trials.
PART 2
SAFETY DA TA
3
1
Subject to paragraph 4, the applicant must submit data as to the safety of the medicinal product.
2
The data submitted by the applicant —
a
must include data which provides information about the following aspects of the safety of the product —
i
pharmacology,
ii
pharmacokinetics, and
iii
toxicology, including —
aa
toxicity,
bb
genotoxicity,
cc
reproductive and developmental toxicity, and
dd
local tolerance,
of the medicinal product; and
b
subject to sub-paragraph (4), must be scientific data.
3
For the purposes of sub-paragraph (2)(b), “scientific data” means —
a
study reports in relation to the product which is the subject of the application,
b
published scientific literature,
or a combination of both.
4
In relation to any aspect of safety of the product, the applicant may submit data other than scientific data if the conditions in sub-paragraph (5) are satisfied.
5
The conditions are that —
a
the applicant has made reasonable attempts to obtain scientific data in relation to that aspect; and
b
having made those attempts —
i
he is satisfied that no scientific data is available as to that aspect of safety, or
ii
he considers that such scientific data as is available may be inadequate to demonstrate an acceptable level of safety in relation to that aspect.
6
The applicant must include with his data —
a
a table of contents;
b
an evaluation of the scientific data, including an explanation as to how the data demonstrates an acceptable level of safety; and
c
where the applicant is submitting data other than scientific data —
i
a statement that he has met the conditions of sub-paragraph (5); and
ii
an explanation as to why an acceptable level of safety can be demonstrated, notwithstanding the lack of scientific data.
4
1
The applicant is not required to submit data as to the safety of the product if —
a
sub-paragraph (2), (3) or (4) applies; and
b
the application is accompanied by a written statement that the product satisfies the conditions set out in that sub-paragraph.
2
This sub-paragraph applies if the product —
a
is derived from a homoeopathic stock which is commonly present in food; and
b
is intended to be administered orally,
and for these purposes “food” has the meaning given to it by Regulation EC No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the Food Safety Authority and laying down procedures in matters of food safety .
3
This sub-paragraph applies if —
a
the national homoeopathic product is derived from a homoeopathic stock from which a medicinal product which has a marketing authorization, certificate of registration, traditional herbal registration or product licence is derived;
b
that medicinal product is within a description, or falls within a class, specified in an order under section 51 of the Act; and
c
the national homoeopathic product has the same route of administration and the same degree of dilution as that medicinal product.
4
This sub-paragraph applies if the product is derived from a homoeopathic stock which —
a
is diluted to at least 1 in 10 24 of the stock, and
b
is not a material of biological origin.
PART 3
EFFICACY DATA
5
The applicant must submit data as to the efficacy of the medicinal product.
6
The data must consist of at least one of the following types of data —
a
study reports in relation to the product which is the subject of the application,
b
published scientific literature, or
c
the results of investigations, commonly known as homoeopathic provings, which consist of the administration of a substance to a human subject in order to ascertain the symptoms produced by that substance.
7
The applicant must include with his data —
a
a table of contents, and
b
an evaluation of the data, including an explanation as to how the data establishes that the product has a recognised level of efficacy in the therapeutic indication for which authorization is sought.
.
Amendment of Schedule 3 to the Marketing Authorisation Regulations
5
In Schedule 3 to the Marketing Authorisation Regulations (offences, penalties etc ) —
a
in paragraph 6(a), for “or Article 6 of Council Regulation ( EEC ) No. 2309/93 ” substitute “, Article 6 of Regulation (EC) No. 726/2004 or, in the case of a holder of an authorization for a national homoeopathic product, Article 8.3 of the 2001 Directive as applied by paragraph 1(3) of Part 1 of Schedule 1A”; and
b
in paragraph 6(cc), for the words after “licensing authority” substitute —
as required by —
i
the third paragraph of Article 23 of the 2001 Directive or, in the case of the holder of an authorization for a national homoeopathic product, that paragraph read in accordance with the modifications in regulation 1(8)(c),
ii
the fourth paragraph of Article 23 of the 2001 Directive, or
iii
the first paragraph of Article 23a of the 2001 Directive.
.
Signed by authority of the Secretary of State for Health
Andrew Burnham
Minister of State
Department of Health
19th July 2006


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Pension Protection Fund (Levy Ceiling) Regulations 2006 and shall come into force on 6th November 2006.
2
In these Regulations, “ the Act ” means the Pensions Act 2004 .
Amounts to be raised by the pension protection levies in 2007-2008
2
For the first financial year after the transitional period , the reference in section 177(2) of the Act (amounts to be raised by the pension protection levies) to “the levy ceiling for the financial year” shall be read as if it were a reference to “£718,750,000”.
Prescribed date for the purposes of section 178 of the Act
3
For the purposes of the definition of “review period” in section 178(4) of the Act (the levy ceiling), the date in the previous financial year on which the period of 12 months ended is 31st July.
Prescribed period for the purposes of section 178 of the Act
4
For the purposes of section 178(7) of the Act, the period before the beginning of which the Secretary of State must discharge the duties imposed by section 178(5) and (6) of the Act in respect of a review period is the period which begins on 1st March and which ends at the time the first financial year after the review period begins.
Manner of consultation
5
The prescribed manner for the consultation required under section 178(9) of the Act is that —
a
the Board shall set out in a consultation document the methods it proposes to use in order to decide on its recommendation to the Secretary of State under section 178(8) of the Act;
b
the Board shall publish the consultation document —
i
on the Pension Protection Fund website ; and
ii
where any person so requests, in a paper format provided by the Board to that person; and
c
the Board shall publish a summary of non-confidential responses received in relation to that consultation, and its responses to those responses —
i
on the Pension Protection Fund website; and
ii
where any person so requests, in a paper format provided by the Board to that person.
Signed by authority of the Secretary of State for Work and Pensions.
James Purnell
Minister of State,
Department for Work and Pensions
10th October 2006
We approve,
Dave Watts
Claire Ward
Two of the Lords Commissioners of Her Majesty’s Treasury
10th October 2006


text:
Citation and commencement
1
These Regulations may be cited as the Tax Avoidance Schemes (Information) (Amendment) Regulations 2006 and shall come into force on 1st August 2006.
Amendment of the Tax Avoidance Schemes (Information) Regulations 2004
2
The Tax Avoidance Schemes (Information) Regulations 2004 are amended as follows.
3
In regulation 2 (interpretation), in the definition of “the Arrangements Regulations” for “Regulations 2004” substitute “Regulations 2006”.
4
1
Amend regulation 4 (time for providing information under section 308, 309, 310 or 312) as follows.
2
In paragraph (5) for the words from “during the period — ” to “in accordance with regulation 8” substitute —
during the period of 30 days beginning with the day after that on which the person enters into the first transaction forming part of the notifiable arrangements.
.
5
Omit regulation 6 (time for providing information: transitional provision).
6
1
Amend regulation 8(6) as follows.
2
Omit “falling within Part 1 of the Schedule to the Arrangements Regulations”.
3
After “notified to the Board” add “on a return in such form as they may specify”.
4
Omit sub-paragraphs (a) and (b).
David Varney
Paul Gray
Two of the Commissioners for Her Majesty’s Revenue and Customs
15th June 2006


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Social Security (Industrial Injuries) (Prescribed Diseases) Amendment Regulations 2006 and shall come into force on 6th April 2006.
2
In these Regulations “the principal Regulations ” means the Social Security (Industrial Injuries) (Prescribed Diseases) Regulations 1985 .
Amendment of the principal Regulations
2
1
In regulation 1(2) of the principal Regulations (interpretation) , in the definition of “primary carcinoma of the lung” after “D8” there shall be inserted “, D8A”.
2
After regulation 20A of the principal Regulations (diffuse mesothelioma – prescribed loss of faculty) there shall be inserted —
Asbestos-related primary carcinoma of the lung – special conditions and prescribed loss of faculty
20B
1
This regulation shall apply to a claim for disablement pension made in respect of the diseases prescribed in paragraphs D8 and D8A of Part I of Schedule 1.
2
On a claim to which this regulation applies —
a
section 103(6) of the Social Security Contributions and Benefits Act 1992 (entitlement after expiry of 90 days) shall apply as if for the words “after the expiry of the period of 90 days (disregarding Sundays) beginning with the day of the relevant accident” there were substituted the words “the day on which he first suffers from a loss of faculty due to primary carcinoma of the lung”; and
b
paragraph 6(1) of Schedule 6 to the Social Security Contributions and Benefits Act 1992 (period to be taken into account by an assessment) shall apply as if the words “beginning not earlier than the end of the period of 90 days referred to in section 103(6) above and in paragraph 9(3) of that Schedule and” were omitted.
3
On a claim to which this regulation applies, the loss of faculty prescribed for the purposes of sub-paragraph (d) of paragraph 1 of Schedule 6 to the Social Security Contributions and Benefits Act 1992 (assessment of extent of disablement) is lung impairment caused by primary carcinoma of the lung.
.
Amendment of Schedule 1 to the principal Regulations
3
1
Part I of Schedule 1 to the principal Regulations (list of prescribed diseases and the occupations for which they are prescribed) shall be amended as follows.
2
For the entry relating to prescribed disease C24 there shall be substituted —
C24.
a
Angiosarcoma of the liver; or
b
osteolysis of the terminal phalanges of the fingers; or
c
sclerodermatous thickening of the skin of the hand; or
d
liver fibrosis,
due to exposure to vinyl chloride monomer.
Exposure to vinyl chloride monomer in the manufacture of polyvinyl chloride. C24A. Raynaud’s phenomenon due to exposure to vinyl chloride monomer. Exposure to vinyl chloride monomer in the manufacture of polyvinyl chloride before 1st January 1984.
.
3
For the entry relating to prescribed disease D8 there shall be substituted —
D8. Primary carcinoma of the lung where there is accompanying evidence of asbestosis.
a
The working or handling of asbestos or any admixture of asbestos; or
b
the manufacture or repair of asbestos textiles or other articles containing or composed of asbestos; or
c
the cleaning of any machinery or plant used in any of the foregoing operations and of any chambers, fixtures and appliances for the collection of asbestos dust; or
d
substantial exposure to the dust arising from any of the foregoing operations.
D8A. Primary carcinoma of the lung.
Exposure to asbestos in the course of —
the manufacture of asbestos textiles; or
spraying asbestos; or
asbestos insulation work; or
applying or removing materials containing asbestos in the course of shipbuilding,
where all or any of the exposure occurs before 1st January 1975, for a period of, or periods which amount in aggregate to, five years or more, or otherwise, for a period of, or periods which amount in aggregate to, ten years or more.
.
4
For the entry in the first column of the entry relating to prescribed disease D9 there shall be substituted —
D9. Unilateral or bilateral diffuse pleural thickening with obliteration of the costophrenic angle.
.
Transitional provision
4
Regulation 3(2) and (4) shall not apply to a period of assessment which relates to a claim which is made before the date on which these Regulations come into force.
Signed by authority of the Secretary of State for Work and Pensions
Margaret Hodge
Minister of State,
Department for Work and Pensions
5th March 2006


text:
1
This Order may be cited as the Fraud Act 2006 (Commencement) Order 2006.
2
To the extent that it is not already in force, the Fraud Act 2006 shall come into force on 15th January 2007.
Gerry Sutcliffe
Parliamentary Under-Secretary of State
Home Office
29th November 2006


text:
Citation
1
This Order may be cited as the Five Lanes CofE VC Primary School (Designation as having a Religious Character) Order 2006.
Designation of School
2
1
The Five Lanes CofE VC Primary School, High Street, Worton, Devizes, SN10 5SE, a voluntary controlled school, is hereby designated as a school having a religious character.
2
The religious denomination in accordance with whose tenets religious education is, or may be, required to be provided at the school in accordance with Schedule 19 to the School Standards and Framework Act 1998 is Church of England.
Shan Scott
A Divisional Manager in the
Department for Education and Skills
9th November 2006


text:
Citation and Interpretation
1
1
This Order may be cited as the Work and Families Act 2006 (Commencement No. 1) Order 2006.
2
In this Order —
“the 1992 Act ” means the Social Security Contributions and Benefits Act 1992 ; and
“the 2006 Act ” means the Work and Families Act 2006.
Provisions coming into force on 27th June 2006
2
The following provisions of the 2006 Act shall come into force on 27th June 2006 —
a
section 1, for the purpose of the power in section 165(1) of the 1992 Act to prescribe the maternity pay period;
b
section 2, for the purpose of the power in section 171ZN(2) of the 1992 Act to prescribe the adoption pay period;
c
section 11, in so far as it relates to the provisions in Schedule 1 to the 2006 Act which are brought into force by this article; and
d
Schedule 1, paragraphs 6, 7, 9, 21, 31, 32, 33 and 34, for the purpose of the powers to prescribe matters by regulations.
Provisions coming into force on 1st October 2006
3
The following provisions of the 2006 Act shall come into force on 1st October 2006 —
a
section 1 for all purposes other than those referred to in article 2;
b
section 2 for all purposes other than those referred to in article 2;
c
section 11 in so far as it relates to the provisions in Schedule 1 to the 2006 Act which are brought into force by this article;
d
Schedule 1, paragraphs 6, 7, 9, 21, 31, 32, 33 and 34, for all purposes other than those referred to in article 2;
e
Schedule 1, paragraphs 8 and 23;
f
section 13;
g
section 14;
h
section 15 in so far as it relates to the provisions in Schedule 2 to the 2006 Act which are brought into force by this Order; and
i
Schedule 2 (repeals) in so far as it gives effect to the following repeals —
i
the definition of “week” in section 171(1) of the 1992 Act; and
ii
section 18 of the Employment Act 2002 .
Provisions coming into force on 6th April 2007
4
The following provisions of the 2006 Act shall come into force on 6th April 2007 —
a
section 12; and
b
Schedule 2 (repeals) in so far as it gives effect to the repeal of section 80F(3), (6) and (7) of the Employment Rights Act 1996 .
Jim Fitzpatrick
Parliamentary Under Secretary of State,
Department of Trade and Industry
25th June 2006


text:
Citation, commencement and interpretation
1
1
This Order may be cited as the Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 and shall come into force on 17th November 2006.
2
In this Order —
“the POM Order ” means the Prescription Only Medicines (Human Use) Order 1997 ; and
“the Pharmacy and General Sale Order ” means the Medicines (Pharmacy and General Sale — Exemption) Order 1980 .
Amendment of article 1 of the POM Order
2
In article 1 of the POM Order (citation, commencement and interpretation), in paragraph (2) —
a
after the definition of “inhaler”, insert the following definition —
“IRME practitioner” means, in relation to a medical exposure, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2000 ;
;
b
after the definition of “maximum strength”, insert the following definition —
“medical exposure” has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000;
;
c
in the definition of “medicinal product”, omit the words from “, but does not include” to the end;
d
for the definition of “operator”, substitute the following definition —
“operator” —
in relation to an aircraft, means the person for the time being having management of the aircraft, and
for the purposes of article 7B, has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000;
; and
e
after the definition of “prolonged release”, insert the following definition —
“radioactive medicinal product” means a medicinal product which is, which contains or which generates a radioactive substance and which is, contains or generates that substance in order, when administered, to utilize the radiation emitted therefrom;
.
Insertion of article 7B of the POM Order
3
After article 7A of the POM Order insert the following article —
Exemption for administration by operators
7B
1
The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to —
a
a radioactive medicinal product, administration of which results in a medical exposure; or
b
any other prescription only medicine if it is being administered in connection with a medical exposure,
where the conditions specified in paragraph (2) are satisfied.
2
The conditions referred to in paragraph (1) are that —
a
the radioactive medicinal product or other prescription only medicine is administered by an operator acting in accordance with the procedures and protocols referred to in regulation 4(1) and (2) of the Ionising Radiation (Medical Exposure) Regulations 2000 which apply to the exposure referred to in paragraph (1);
b
that medical exposure has been authorised by an IRME practitioner or, where it is not practicable for an IRME practitioner to authorise the exposure, by an operator acting in accordance with written guidelines issued by an IRME practitioner;
c
the IRME practitioner is the holder of a certificate granted pursuant to the Medicines (Administration of Radioactive Substances) Regulations 1978 ;
d
the radioactive medicinal product or other prescription only medicine is not a controlled drug; and
e
in the case of a prescription only medicine which is not a radioactive medicinal product, it is specified in the protocols referred to in sub-paragraph (a).
Amendment of Schedule 5 to the POM Order
4
1
Schedule 5 to the POM Order (exemption for certain persons from section 58(2) of the Act) is amended as follows.
2
In Part I (exemption from restrictions on sale or supply) —
a
in column 1 (persons exempted), for paragraph 10 substitute the following paragraph —
10
Registered chiropodists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2.
; and
b
in column 2 (prescription only medicines to which the exemption applies), in paragraph 10 —
i
in sub-paragraph (c), after “volume;” omit “and”,
ii
in sub-paragraph (d), for “in weight.” substitute “in weight; and”, and
iii
at the end, add —
e
Amoxicillin;
f
Erythromycin;
g
Flucoxacillin;
h
Tioconazole 28%; and
i
Silver Sulfadiazine.
3
In Part II (exemptions from the restriction on supply), after paragraph 7 insert —
8 Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee. 8 Prescription only medicines supplied to a person specified in column 1 in response to an order in writing signed by a doctor. 8 The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services.
.
4
In Part III (exemptions from restriction on administration) —
a
in column 1 (persons exempted), for paragraph 1 substitute the following paragraph —
1
Registered chiropodists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2.
; and
b
in column 2 (prescription only medicines to which the exemption applies), in paragraph 1, insert at the appropriate place in the alphabetical order of entries as they appear in that paragraph —
Adrenaline
Levobupivacaine hydrochloride
Methylprednisolone
Ropivacaine hydrochloride
.
Amendment of Schedule 1 to the Pharmacy and General Sale Order
5
1
Schedule 1 to the Pharmacy and General Sale Order (exemptions for certain persons from sections 52 and 53) is amended as follows.
2
In Part I —
a
in column 1 (persons exempted) —
i
in paragraph 1, for “State registered” substitute “Registered”, and
ii
for paragraph 1A substitute the following paragraph —
1A
Registered chiropodists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2.
; and
b
in column 2 (medicinal products to which the exemption applies) —
i
in paragraph 1, in sub-paragraph (c) —
aa
after “Glutaraldehyde” insert “1.0 per cent Griseofulvin”, and
bb
after “acid” insert “1.0 per cent Terbinafine”, and
ii
in paragraph 1A(a) —
aa
after “volume;” omit “and”, and
bb
after “1 per cent by weight in weight;” insert —
v
Amoxicillin;
vi
Erythromycin;
vii
Flucoxacillin;
viii
Tioconazole 28%; and
ix
Silver Sulfadiazine;
.
3
In Part II, after paragraph 14 insert —
15. Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee. 15. All pharmacy medicines, all medicinal products on a general sale list and prescription only medicines which are sold or supplied to a person specified in column 1 of this paragraph in response to an order in writing signed by a doctor. 15. The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services.
.
Signed by authority of the Secretary of State for Health
Andy Burnham
Minister of State,
Department of Health
17th October 2006
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
Andrew McCormick
Permanent Secretary,
Department of Health, Social Services and Public Safety
19th October 2006


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Registered Pension Schemes (Splitting of Schemes) Regulations 2006 and shall come into force on 6th April 2006.
2
In these Regulations —
“group of employers” means two or more employers who are formally or informally linked to each other by reasons of common management, shareholding, staff or close business interests;
“ HMRC ” means the Commissioners for Her Majesty’s Revenue and Customs;
“split scheme” means a registered pension scheme that is being treated, in accordance with regulation 2, as having been split into two or more sub-schemes;
“sub-scheme” means a scheme which forms part of a split scheme and which is being treated as a separate pension scheme under and for the purposes set out in these regulations;
“split scheme administrator” means a scheme administrator of a split scheme;
“sub-scheme administrator” means the scheme administrator of a sub-scheme appointed in accordance with the rules of the split scheme to be responsible for the discharge of the functions conferred or imposed on the sub-scheme administrator by or under these Regulations;
“section” without more, means a section of the Finance Act 2004;
“schedule” without more, means a schedule to the Finance Act 2004.
Description of schemes to be split
2
1
The following registered pension schemes shall be treated as split schemes for the purposes of these Regulations —
a
the registered pension schemes listed in Schedule 1;
b
a registered pension scheme which meets the conditions in paragraph (5);
c
a successor scheme to any of the above schemes.
2
A successor scheme is a registered pension scheme established to take over some or all of the rights and obligations of a split scheme.
3
The scheme administrator of a successor scheme shall notify HMRC of any sub-schemes in respect of which he is assuming responsibility immediately following registration of the successor scheme.
The notification shall —
be in a form specified by HMRC, and;
contain any information reasonably required by HMRC.
4
Schedule 2 lists the schemes which, at the coming into force of these Regulations, are to be treated as sub-schemes of the split schemes referred to in sub-paragraph (1).
5
The conditions referred to in sub-paragraph (1)(b) are as follows.
Condition A
The pension scheme falls within Paragraph 1(1)(a) or (c) of Schedule 36 to the Finance Act 2004.
Condition B
The pension scheme provides benefits to or for the benefit of the employees of two or more employers.
Condition C
The rules of the pension scheme as at 28 th February 2006 provided for the establishment of separate schemes for each of the participating employers or group of employers and for the administration of such schemes to be carried out by separate scheme administrators.
6
A successor sub-scheme is a scheme established to take over some or all of the rights and obligations of a sub-scheme.
7
The scheme administrator of a successor sub-scheme shall notify HMRC immediately following his assumption of liability of the successor sub-scheme.
The notification shall —
be in a form specified by HMRC, and
contain any information reasonably required, including the name and address of the scheme administrator.
Responsibilities and liabilities of sub-scheme administrators
3
1
The sub-scheme administrator of a sub-scheme shall assume the liabilities and responsibilities set out in Schedule 3 to these Regulations in relation to that scheme.
2
In the provisions referred to in that Schedule any reference to the scheme administrator shall be read as a reference to the sub-scheme administrator.
3
The split scheme administrator shall cease to have responsibility or liability in relation to the matters referred to in paragraph (1) in respect of the sub-scheme.
4
The provisions of section 270(2) and (3) (meaning of “scheme administrator”) apply to the sub-scheme administrator and the references to the scheme administrator in those subsections shall be read as references to the sub-scheme administrator).
5
Section 272 (trustees etc. liable as scheme administrator) applies to sub-scheme administrators with the following modifications —
a
in subsection (1)“ for “registered pension scheme”; substitute “sub-scheme”;
b
in subsections (1)(a) to (c), (2)(a) and (b) for “scheme administrator” (in each place) substitute “sub-scheme administrator”;
c
in subsections (1)(a) to (c) and (2), (3) and (5) for “pension scheme” (in each place) substitute “sub-scheme”;
d
in subsection (2) —
i
in paragraph (a) after “by virtue of this Part” insert “as applied by regulation 3 of the Registered Pensions (Splitting of Schemes) Regulations 2006”; and
ii
in paragraph (b) after “by or under this Part.” insert “as applied by the Registered Pensions (Splitting of Schemes) Regulations 2006”; and
e
in subsection (4) for “pension scheme” substitute “sub-scheme”.
6
Section 273 (members liable as scheme administrator) applies to members of a sub-scheme with the following modifications —
a
in subsection (1) for “registered pension scheme” substitute “sub-scheme”;
b
in subsections (1)(a) and (b) for “pension scheme” substitute “sub-scheme”;
c
in subsection (1)(a) after “(trustees, etc.)” add “(as modified by regulation 3 of the Registered Pensions (Splitting of Schemes) Regulations 2006)”;
d
in subsection (1)(b) omit the words “or section 242 (de-registration charge)”;
e
in subsections (2) and (4) for “pension scheme” substitute “sub-scheme”;
f
in subsection (5)(a) for “the pension scheme” substitute “the split scheme”;
g
in subsections (5)(b) and (d) for “the pension scheme” substitute “the sub-scheme”;
h
in subsection (5)(c) after the words “that the pension scheme was” add “part of”;
i
in subsection (10) for “the pension scheme” substitute “the sub-scheme”.
7
Section 274(2) (supplementary) applies to sub-scheme administrators with the following modifications —
a
for “scheme administrator” substitute “sub-scheme administrator”; and
b
for “registered pension scheme” substitute “sub-scheme”.
4
1
Section 209(5) (unauthorised payments surcharge) shall be modified as follows.
a
in paragraph (b) delete “and”;
b
in paragraph (c) after “the scheme administrator” add “and”;
c
after paragraph (c) add —
d
the sub-scheme administrator,
.
5
1
Paragraph 11 of Schedule 31 (insertion of chapter 15A into ITEPA 2003) shall be modified as follows.
2
After subsection (4) of the inserted section 636A insert —
4A
In the case of a registered pension scheme which is a split scheme for the purposes of the Registered Pensions Schemes (Splitting of Schemes) Regulations 2006, subsections (3) and (4) shall have effect as if the references to the scheme administrator were to the sub-scheme administrator (within the meaning of those Regulations).
.
3
Paragraph 1 of Schedule 35 (consequential amendments to the Taxes Management Act 1970) shall be modified as follows.
a
in the substitution to section 9(1A) of the Taxes Management Act 1970, in sub-paragraph (a) delete “or”; and
b
after sub-paragraph (a) add —
ab
is chargeable on the sub-scheme administrator of a sub-scheme under Part 4 of the Finance Act 2004 as modified by the Registered Pensions (Splitting of Schemes) Regulations 2006, or
4
Paragraph 16 of Schedule 35 (consequential amendments to section 349B(3) of ICTA ) shall be modified as follows.
5
After the substituted sub-paragraph (i) add —
ia
the sub-scheme administrator of a sub-scheme which forms part of a split scheme pursuant to the Registered Pensions (Splitting of Schemes) Regulations 2006;
6
Paragraph 33 of Schedule 35 (consequential amendments to section 824(9) of ICTA) shall be modified as follows.
7
After the insertion of the words “scheme administrators of registered pension schemes” add —
sub-scheme administrators of sub-schemes which form part of a split scheme pursuant to the Registered Pensions (Splitting of Schemes) Regulations 2006
.
David Varney
Paul Gray
Two of the Commissioners for Her Majesty’s Revenue and Customs
9th March 2006


text:
Citation and commencement
1
These Regulations may be cited as the Stamp Duty and Stamp Duty Reserve Tax (Extension of Exceptions relating to Recognised Exchanges) Regulations 2006 and shall come into force on 16th February 2006.
Extended application of provisions specified in section 50(2) of the Finance (No.2) Act 2005
2
1
The application of the provisions specified in section 50(2) of the Finance (No.2) Act 2005 (“the relevant provisions”) is extended to the following market, which is a multilateral trading facility (or, assuming compliance with the provisions of Title II of the Directive (authorisation and operating conditions), would be such a facility), namely the market known as Instinet CHi-X and operated by Instinet Europe Limited.
2
Regulations 3 to 7 of the Stamp Duty Reserve Tax (Extension of Exceptions relating to Recognised Exchanges) Regulations 2005 apply to the market mentioned in paragraph (1) as they apply to the multilateral trading facilities listed in paragraphs (a) to (c) of regulation 2 of those Regulations.
Gillian Merron
Dave Watts
Two of the Lords Commissioners of Her Majesty’s Treasury
25th January 2006


text:
Citation and commencement
1
These Regulations may be cited as the Licensing Act 2003 (Persistent Selling of Alcohol to Children) (Prescribed Form of Closure Notice) Regulations 2007 and come into force on 3rd May 2007.
Prescribed form
2
A closure notice given pursuant to section 169A of the Licensing Act 2003 (Closure notices for persistently selling alcohol to children) is to be in the form set out in the Schedule.
Shaun Woodward
Parliamentary Under Secretary of State
Department for Culture, Media and Sport
11th April 2007