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Bulletin 307
April 2012
Consumer Law Bulletin
Roland Rowell JP BA LLM LLD DCA FCMI FTSI Trading and Consumer Law Consultant.
General Editor of Butterworths Law of Food and Drugs and an Editor of Butterworths Trading and Consumer Law Filing instructions: This Bulletin contains material available on 1 April 2012.
It should be filed behind the Bulletins Guide Card and in front of Bulletin
No 306. Remove Bulletin 294. If desired Bulletin 294 may be retained outside
the Binder for future reference. The Binder should now contain Bulletins Nos
295 to 307.
SPECIAL REPORT
“Enhancing Consumer Confidence through Effective
Enforcement” – BIS Consultative Document
This consultation has been launched by Norman Lamb MP, Minister forEmployment Relations, Consumer and Postal Affairs. Providing it does notsimply “run into the sand” it has the potential to be one of the mostimportant events in consumer protection, and for the Trading StandardsService in particular, for at least two decades.
It puts forward the position that markets work best when consumers havetrust in the businesses with which they contract and appears to herald thebiggest ever shake-up of local trading standards enforcement in recent years.
It identifies that high levels of consumer confidence encourage experimenta-tion which helps market entry, boosts competition and drives innovation. Inother words “trading standards” is not just “consumer protection” butensures a vibrant and fair market place from which consumers are not“protected” – but from which they benefit. Less certain is the document’sassertion that as consumer laws originate in a variety of Acts and regulationsthis results in “making it complex and confusing” going on seemingly tosuggest that the answer lies in a “one Big Book” approach – something that israther naive. It is naive because the powers provided by Parliament in orderto secure enforcement of the relevant statute or instrument are the toolsnecessary to do the job, to secure adequate enforcement and ensure that theintentions of Parliament are not thwarted by difficulties experienced in Letterpart Ltd – Typeset in XML ❄ Tel: 01737 223329 ❄ e-mail: sales@letterpart.com
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SPECIAL REPORT
enforcement. “Broad Brush” approaches might seem attractive and innova-tory but usually lead to problems down the line. Large ships look good butthey all depend on rivets to hold it all together.
However, in order to secure this important initiative, the government isplanning a Consumer Bill to “clarify and simplify UK consumer law”.
Rightly, it highlights that consumer confidence is rapidly eroded by roguetraders and puts forward the aim to strengthen the ability of local authorityTrading Standards Services to tackle them. Interestingly, and quite correctly,it states: “Government also needs to tear down the bureaucratic barriers thatprevent enforcers from operating efficiently across local authorityboundaries, so that Trading Standards can be organised regionally andnationally as well as locally. Effective and efficient enforcement ofconsumer law is essential for a consumer law regime that works well forboth businesses and consumers.” That is well-observed and long overdue. It is unclear, however, how such anew regime will be put in place, how it will be funded and what the reportinglines will be. And this is the crux of the matter. The laws exist already; it is theenforcement structure that is unfit for the 21st century. This hampers theenforcement effort in spite of the efforts of many local initiatives over the lastfew years to ensure more effective enforcement. Above all it causes immensefrustration for the enforcement officer should the “powers provisions” pre-vent them from acting to maximum efficiency. This is therefore an importantopportunity to strike off the restrictive shackles of bureaucracy unleashingthe professionalism and enthusiasm of the Trading Standards Service. Therehave been officer-initiated initiatives that have in recent years worked “cross-border” and that should be widened. What the government seems to besuggesting is that the only border that matters is “the borders of the UK”.
Stripping away the oft-used restriction to act only within a certain localauthority area would therefore be useful. Even better would be a single,national Trading Standards Service freed from the shackles of local bureau-cracy but retaining a statutory responsibility to answer to the people it servesin the smallest community.
In moving the initiative forward, the government also expresses a determina-tion to reduce the regulatory burden on business and identifies that “enforc-ers investigatory powers are currently set out in many different andoverlapping pieces of legislation and businesses are uncertain as to whichpowers apply in which cases”. The document does not, however, explain what“overlap” there is and it is therefore vital that this does not end up as a“hacking exercise”. Setting out generic powers in one place would ensure thatthey are simple and transparent so that both businesses and enforcers knowthe extent of officers’ powers, but the document is rather lacking in detail onthis issue. It is not possible to have a “one power fits all” as different lawsrequire different approaches for different types of enterprise and that is whypowers must “fit” the situation. The last thing the Trading Standards Serviceneeds is to be hampered while waiting for decisions of the higher courts as to Letterpart Ltd – Typeset in XML ❄ Tel: 01737 223329 ❄ e-mail: sales@letterpart.com
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SPECIAL REPORT
what the “new powers” mean. The document asserts: “Additional safeguardsbefore such powers can be exercised will reduce the regulatory burden onbusinesses and also protect civil liberties.” This suggests that civil libertieshave been infringed by the Trading Standards Service, which is surprising andwould appear to be unfounded, particularly so as no evidence is put forwardin the document to quantify the assertion. Powers are the basic “tool of thetrade” and TSOs are well aware of the need to remain intra vires. Thereforeany of blunting of that basic “tool” would be counterproductive.
The government aims to simplify the law, facilitate efficient organisation ofenforcement resources and reduce burdens on honest businesses and enforc-ers, where possible. This consultation seeks views on a series of proposalsdesigned to achieve these aims and views are sought. It sets out in Ch 2 whichconsumer law enforcement bodies will have the proposed generic set ofpowers available to them, which legislation they have the duty to enforce andthe business sectors which are regulated by this legislation. Each poweravailable to the enforcement body listed is set out. The proposals coverpowers ranging from the power to make test purchases, and request informa-tion to the power of entry. Proposals are also made in relation to the offenceof obstruction of officers. Safeguards are proposed in relation to the genericinvestigatory powers, such as a requirement for officers to give businessesreasonable notice of routine inspections, subject to a number of exemptions.
Care should be taken here as inspections should ascertain what is happeningin a business at the point of inspection. It is the outcome from that inspectionwill correct any fault. Notifying businesses prior to inspection would alsocreate, not diminish, bureaucracy, increases costs and engender. Sending“notices of inspections” to a local high street to warn the traders of animpending inspection takes time, carries costs and creates bureaucracy. Aspeeding motorist approaching a speed trap would be likely to take their footoff the accelerator if “reasonable notice” of the exercise was posted. Carefuldrivers observing the speed limit have nothing to fear from the radar beam.
Further, there will be many situations where it is not possible to carry out thistask – irregular markets and car boot fairs are examples.
Improving Cross-Boundary Cooperation and Authorisation
As the current law enabling Trading Standards Services to work across localauthority boundaries is open to different interpretations uncertainty canresult with administrative costs for enforcers. This reduces the effectivenessand efficiency of enforcement to tackle rogue traders and so the proposals inCh 3 aim to ensure that cross boundary-working is as simple and efficient aspossible for Trading Standards Services. Clarifying this is sensible andhelpful.
Representation in Courts
An important initiative – which recognises the contribution made by TradingStandards professionals in England and Wales when presenting criminalcases in magistrates’ courts – identifies that they are unable to present civilcases in county courts. This means that the cost of civil enforcement is often Letterpart Ltd – Typeset in XML ❄ Tel: 01737 223329 ❄ e-mail: sales@letterpart.com
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SPECIAL REPORT
higher than it needs to be and this cost contributes to the relatively lownumber of civil enforcement actions by Trading Standards Services comparedto the number of criminal prosecutions. It is proposed using an existingApproved Regulator, to accredit/enable individual Trading Standards profes-sionals to present cases in county courts and thereby encourage the use ofcivil enforcement. It should be remembered that there is a precedent here asmany of the previous metropolitan county council’s TSOs were ofteninvolved in civil cases in the small claims courts.
The consultation recognises that currently the only statutory qualificationrequirement for Trading Standards professionals relates to weights andmeasures enforcement, there being no equivalent statutory qualificationrequirement in relation to other consumer law that they enforce. Thiscontrasts with the Health and Safety at Work etc Act 1974 which leaves it toenforcement bodies to determine what qualifications are suitable for theirofficers. It is therefore proposed to introduce a more general competencyrequirement for Trading Standards professionals to ensure the ongoingcompetency of officers across the range of consumer law they enforce. Thiswill provide assurance to businesses that officers can support them incomplying with their legal obligations. While these comments in the Consul-tation may not do justice to the many highly qualified TSOs serving theircommunities it introduces for the first time a much greater focus on the needfor clarity in the area of competence – an unqualified person is unlikely tohave the competence of a trained and qualified person. This is sensible and,particularly at chief officer level, it is surely essential to have a trained,qualified and experienced person at the “controls”. Greater clarity in thisarea coupled with a requirement on employing authorities to employ person-nel with the right qualifications and training is therefore vital to ensuring thatthe expectations of the public are met and the consultation is right to identifyit together with how they can be assessed and maintained. These proposalsare therefore to be welcomed.
Enabling Competition in the Calibration of Measurement
Standards Market
Under current rules in the Weights and Measures Act 1985, Trading Stand-ards Services are required to periodically submit their reference measurementstandards (known as local standards) to the National Measurement Office totest them for accuracy. These statutory controls ensure that the standardsused by Trading Standards Services to check the accuracy of instruments inuse for trade are themselves accurate. Since the 1985 Act, a new route hasemerged for calibration of measurement standards in the private sectorthrough laboratories accredited by the United Kingdom Accreditation Ser-vice and this route could save local authorities money, if they were allowed touse it. It is propose to open up the market to allow competition forcalibration of standards. There will be no cost to business but will be anopportunity for business to enter the market if they choose.
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Responses
Provision is made for responding. Those responding should state whetherthey do so as an individual or representing the views of an organisation. Ifresponding on behalf of an organisation, make it clear who the organisationrepresents by selecting the appropriate interest group on the consultationresponse form and, where applicable, how the views of members wereassembled. A copy of the Consultation Response form appears on the BISwebsite, available also electronically. Responses to this consultation must bereceived by 20 June 2012 and can be submitted via letter, fax or preferably byemail to: TSPowers@bis.gsi.gov.uk; Suzanne Redding, Consumer & Compe-tition Policy, Department of Business, Innovation and Skills, I VictoriaStreet, London SW1H OET Tel: 020 7215 0439; Fax: 020 7215 0357. Thisconsultation can be found at: http://www.bis.gov.uk/consultations and is alsoavailable from: BIS Publications Orderline, ADMAIL 528, London SW1W8YT. Tel: 0845–015 0010 Fax: 0845–015 0020. Minicom: 0845–015 0030.
www.bis.gov.uk/publications NEW LEGISLATION
Authorised Officers (Meat Inspection) (Revocation)
(England) Regulations 2012, SI 2012/690 – in force
6 April 2012
These Regulations were made under the Food Safety Act 1990, s 5(6) andapply to England only. They revoke the Authorised Officers (Meat Inspec-tion) Regulations 1987, SI 1987/133.
NEW EU LEGISLATION
“Armagh Bramley Apples” PGI – Regulation 185/2012
(OJ No L 69; 8.3.2012)
This Regulation is made under Regulation 510/2006 on the protection ofgeographical indications and designations of origin for agricultural productsand foodstuffs, entering into force on 28 March 2012. It enters the name“Armagh Bramley Apples (PGI)” in the register of protected designations oforigin and protected geographical as follows: “Agricultural products intended for human consumption listed inAnnex I to the Treaty: Class 1.6. Fruit, vegetables and cereals, fresh orprocessed. United Kingdom Armagh Bramley Apples (PGI).” Residue limits for Nitroxinil – Regulation 201/2012
(OJ No L 71; 9.3.2012)
This Regulation is made under Regulation amends the Annex toRegulation 37/2010 on pharmacologically active substances and their classi-fication regarding maximum residue limits in foodstuffs of animal origin, asregards the substance nitroxinil. It entered into force on 12 March 2012.
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Pegylated Bovine Granulocyte Colony Stimulating
Factor – Regulation 202/2012 (OJ No L 71; 9.3.2012)
This Regulation amends the Annex to Regulation 37/2010 on pharmacologi-cally active substances and their classification regarding maximum residuelimits in foodstuffs of animal origin, as regards the substance pegylatedbovine granulocyte colony stimulating factor. It entered into force on12 March 2012.
Changes to Rules for Organic Wine –
Regulation 203/2012 (OJ No L 71; 9.3.2012)
This Regulation amends Regulation 889/2008 laying down detailed rules forthe implementation of Regulation 834/2007 regarding detailed rules fororganic wine. It entered into force on 1 August 2012.
Residue limits for Closantel – Regulation 221/2012
(OJ No L 75; 15.3.2012)
This Regulation amends the Annex to Regulation 37/2010 on pharmacologi-cally active substances and their classification regarding maximum residuelimits in foodstuffs of animal origin, as regards the substance closantel. Itentered into force on 18 March 2012.
Residue limits for Triclabendazole – Regulation 222/2012
(OJ No L 75; 15.3.2012)
This Regulation amends the Annex to Regulation 37/2010 on pharmacologi-cally active substances and their classification regarding maximum residuelimits in foodstuffs of animal origin, as regards the substance triclabendazole.
It entered into force on 18 March 2012.
Specifications for Food Additives – Regulation 231/2012
(OJ No L 83; 22.3.2012)
This Regulation lays down the Specifications relating to origin, purity criteriaand any other necessary information for food additives listed in Annexes IIand III to Regulation 1333/2008. It updates the specifications previouslydeveloped for food additives in Directive 2008/128, which lays down specificpurity criteria concerning colours for use in foodstuffs, Directive 2008/84laying down specific purity criteria on food additives other than colours andsweeteners and Directive 2008/60 laying down specific purity criteria concern-ing sweeteners for use in foodstuffs. These three Directives are updated andtaken over to this new Regulation, the three predecessor Directives beingrepealed.
Colours in Food – Regulation 232/2012 (OJ No L 78;
17.3.2012)
This Regulation amends Annex II to Regulation 1333/2008 as regards theconditions of use and the use levels for Quinoline Yellow (E 104), Sunset Letterpart Ltd – Typeset in XML ❄ Tel: 01737 223329 ❄ e-mail: sales@letterpart.com
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Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E124). It applies from 1 June 2013. Foods containing Quinoline Yellow (E104), Sunset Yellow FCF/ Orange Yellow S (E 110) and Ponceau 4R,Cochineal Red A (E 124) that have been lawfully placed on the market before1 June 2013 but that do not comply with the provisions of this Regulation,may continue to be marketed until stocks are exhausted. It entered into forceon 6 April 2012 and applies from 1 June 2013.
Sampling & Analysis for Official Control of Dioxins –
Regulation 252/2012 (OJ No L 84; 23.3.2012)
Sampling for the official control of the levels of dioxins, furans, dioxin-likePCBs and non-dioxin-like PCBs in the foodstuffs listed in s 5 of the Annex toRegulation 1881/2006 must be carried out in accordance with the methods setout in Annex II to that Regulation. The methods address the preparation ofsamples and subsequent analyses for the foodstuffs listed in s 5 of the Annexto Regulation 1881/2006 and must be carried out in accordance with themethods set out in Annex III to this Regulation. Analyses for the officialcontrol of the levels of non-dioxin-like PCBs in foodstuffs listed in s 5 of theAnnex to Regulation 1881/2006 must be carried out in accordance with therequirements for analytical procedures set out in Annex IV to this Regula-tion. Regulation 1883/2006 is repealed. This Regulation entered into force onthe 12 March 2012 and applies from that date.
List of Natural Mineral Waters – Notice from Member
States (OJ No C 83; 21.3.2012)
This lists the natural mineral waters recognised by Belgium, Bulgaria, CzechRepublic, Denmark, Germany, Estonia, Ireland, Greece, Spain, France, Italy,Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Netherlands, Austria,Poland, Portugal, Romania, Slovenia, Slovakia, Finland, Sweden andUnited- Kingdom.
PROPOSED LEGISLATION
“Newmarket Sausage” – Application to Register PGI
(OJ No C 69; 7.3.2012)
This entry is the publication under Regulation 510/2006 to register a “Pro-tected Geographical Indication” (PGI) in respect of this product.
“Use-by” Dates – Food Labelling Regulations 1996,
SI 1996/1499
Torfaen County Borough Council v Douglas Willis Limited [2012] EWHC 296(Admin); QBD Facts: This is an appeal by way of case stated by the Gwent Justices. It
concerns the Food Labelling Regulations 1996, SI 1996/1499. The appeal
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raises a point of construction of reg 44(1), which deals with offences andpenalties for contravention of the food labelling requirements set out in theRegulations. The particular question for the court relates to the correctconstruction of reg 44(1)(d), which states that any person who: “sells foodafter the date shown in a ‘use by’ date relating to it” is guilty of an offence.
Held: In order to obtain a conviction of an offence under reg 44(1)(d), the
prosecution has to prove, to the criminal standard:
that, at the point that the food was ready for delivery to the ultimateconsumer or to a caterer, it was “highly perishable” and so needed then,and thereafter, to be labelled with a “use by” date; the defendant was, at the time of the alleged offence, selling the food,within the definition of “sell” in reg 2; and at the time of the alleged offence, the date on the “use by” label hadpassed.
The fact that food is, when being sold, labelled with a “use by” date must beprima facie evidence that the food required to be so labelled in accordancewith regs 2, 4 and 5. If food is so labelled when being sold, then there wouldbe an evidential burden on the defendant to demonstrate that the label hadnot, in fact, been required.
[On a secondary issue]: If food has been given a “use by” date and thenfrozen so that it is no longer highly perishable, does that “use by” date ceaseto have effect, the answer: “no”. If food requires a “use by” label at the pointat which it is ready for delivery to the ultimate consumer or caterer, then itmust be labelled with a “use by” date at that point. If the food is subsequentlyfrozen, it does not cease to require to have a “use by” label attached to it. Ifsuch food is subsequently sold (within the definition in reg 2) after the “useby” date, there will be an offence under reg 44(1)(d).
In the light of this decision of the Divisional Court the commentary on “useby dates” in Butterworths Law of Food & Drugs will require suitable amend-ment. This will appear in Issue 101.
British Retail Consortium: Global Standard for Food
Safety Russian PDF Version
Russian translation of Global Standard for Food Safety Issue 6 PDF (ISBN9780117069688). £90.00 + VAT – 9780117069534.
British Retail Consortium: Global Sandard for Food
Safety Russian Print Version
Russian translation of Global Standard for Food Safety Issue 6 Print version(ISBN 9780117069671). £95.00 . – 9780117069534.
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INFORMATION
Food Businesses Targeted by Bogus Calls
The Food Standards Agency has warned food businesses to be on their guardfollowing a recent spate of bogus phone calls from someone claiming to beemployed by the FSA. The Agency has been alerted to a number of incidentsinvolving pub chains in Kensington, Chelsea, Westminster and Lincolnshirethat have been contacted by someone claiming to be from the FSA. The callersays an environmental health officer will make a visit in the next fortnight toupdate the pub’s manager on new food legislation and asks for their mobilephone number. They then say they will text the manager within 48 hours ofthe visit to confirm arrangements. Visits to food businesses are arranged bylocal authorities, not the FSA, and most hygiene inspections are unan-nounced, with EHOs introducing themselves once they arrive at the business.
FSA is monitoring the situation and urge businesses to be on their guard.
Anyone receiving these, or any other suspicious calls, to contact the Agency’sFood Fraud Hotline on 020 7276 8527 or to email the FSA Food Fraudteam: foodfraud@foodstandards.gsi.gov.uk. The relevant local authorityshould also be contacted.
FSA Update – Products free of Colours
The Food Standards Agency (FSA) has updated its list of product rangesthat do not contain the six food colours associated with possible hyperactiv-ity in young children. Two more companies producing product lines free ofthe colours have been added to the list: FSA is publicising the product ranges to encourage the food industry toparticipate in the voluntary ban agreed by Ministers in November 2008. Thelist includes companies that have product ranges that have never containedthe six colours and companies that have reformulated their product ranges toremove the colours. Any food manufacturer, retailer or caterer wishing tonotify the Agency that their brands or products are free of these coloursshould Review of the Food Safety (Sampling & Qualifications)
Regulations 1990, SI 1990/2463
The purpose of the Review is to review and update national legislation on theFood Safety (Sampling & Qualifications) Regulations 1990, SI 1990/2463.
The primary aim will be to ensure that qualifications listed for food/publicanalysts and food examiners are up to date and to remove/amend obsoleteprovisions found within the Regulations. It seeks stakeholder’s views as theproposal will include amendments to the food examiner qualifications andsampling provisions and introduce guidance on procedures to recogniseequivalent EU qualifications and training for food/public analysts and food Letterpart Ltd – Typeset in XML ❄ Tel: 01737 223329 ❄ e-mail: sales@letterpart.com
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examiners, in particular the qualifications and training requirements for foodexaminers. Also, there are aspects of the sampling provisions that requireupdating. Consideration also needs to be given to ensure that qualificationrequirements for a food analyst/examiner are not too restrictive and thatanalysts with equivalent qualifications can be considered. FSA conducted aninformal consultation in May 2011 to gather the views of key stakeholders onhow to proceed with the review of the Sampling & Qualifications Regula-tions. Responses received from stakeholders and subsequent discussions withinternal and external parties form the basis of the proposal suggested withinthis formal consultation.
Key proposal(s)
Revocation of the Food Safety (Sampling & Qualification) Regula-tions 1990 and replacement with a consolidated Statutory Instrument; Update the qualifications for food examiners; Introduce guidance on procedures to recognise equivalent qualifica-tions Consultation
This formal consultation follows a previous informal consultation. It will beconducted independently by each of the four UK countries. FSA welcomeany comments on the proposal, in particular on the key questions set outbelow. All responses received as part of this consultation will be given carefulconsideration and will be summarised and published on the FSA’s website indue course.
Questions asked in this Consultation
FSA would be interested in whether you agree with the proposedamendments to the Food Safety Sampling and Qualifications Regula-tions 1990.
FSA would be interested in any suggestions you may have for anon-regulatory option that would meet the policy objective – provideevidence that supports your views.
Questions asked in the Impact Assessment
There are a range of questions posed within the document that are notereproduced here.
Responses are required by close Monday 4 June 2012. State in any responsewhether you are responding as a private individual or on behalf of anorganisation/company (including details of any stakeholders your organisa-tion represents). Comments to: Bhavna Parmar, SMLP Branch, ARD, FoodStandards Agency, 1st floor Aviation House 125 Kingsway, London’ WC2B6NH.
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FERTILISERS & FEEDINGSTUFFS
FSA – Views Sought on Lactic Acid Usage on
Beef Carcasses
The FSA is asking businesses to provide their views on the use of lactic acidto reduce microbiological surface contamination on beef carcasses, proposedin a draft EU regulation. FSA is asking business to provide their views onsuch usage. FSA has already consulted widely to inform the UK votingposition on the EU draft regulation and would like to consult further in orderto assess the likely impact on UK businesses. If authorised, the use of lacticacid on beef carcasses would be permissive rather than mandatory. A vote onthe Commission Regulation is expected in spring 2012. Businesses in Eng-land, Wales, Northern Ireland and Scotland are asked to submit their views,for instance whether they would use lactic acid if approved, what the costmight be, and whether staff would require additional training in the process.
The Agency will review the responses to determine whether a formal Regula-tory Impact Assessment is necessary. Responses are required by 5pm onFriday 30 March 2012.
FERTILISERS & FEEDINGSTUFFS
Fertilisers – Regulation 223/2012 (OJ No L 75; 15.3.2012)
This Regulation amends Regulation 2003/2003 on fertilisers making a seriesof changes across a number of products. It entered into force on 4 April2012.
Approval of Feed Producers – Regulation 225/2012
(OJ No L 77; 16.3.2012)
This Regulation amends Annex II to Regulation 183/2005 on the approval ofestablishments marketing for feed use products derived from vegetable oilsand blended fats. It addresses specific requirements for production, storage,transport and dioxin testing of oils, fats and products derived therefrom. Itentered into force on 5 April 2012.
Amendment of Benzoic Acid Usage –
Regulation 226/2012 (OJ No L 77; 16.3.2012)
This Regulation amends Regulation 1730/2006 amending as regards theconditions of use of benzoic acid (holder of authorisation Emerald KalamaChemical BV). The Annex to that regulation is replaced. It entered into forceon 5 April 2012.
Authorisation of Lactococcus lactis as Feed Additive –
Regulation 227/2012 (OJ No L 77; 16.3.2012)
This Regulation concerns the authorisation of Lactococcus lactis (NCIMB30117) as a feed additive for all animal species. It entered into force on5 April 2012.
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FERTILISERS & FEEDINGSTUFFS
Authorisation of Alpha-galactosidase (EC 3.2.1.22)
produced by Saccharomyces cerevisiae as Feed
Additive – Regulation 237/2012 (OJ No L 80; 20.3.2012)
This Regulation concerns the authorisation of alpha-galactosidase (EC3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as afeed additive for chickens for fattening (holder of authorisation KerryIngredients and Flavours). It entered into force on 9 April 2012.
Monitoring for Ergot Alkaloids – Recommendation
2012/154 (OJ No L 77; 16.3.2012)
This Recommendation concerns the monitoring of the presence of ergotalkaloids in feed and food. (See the “Food Division” of this Issue of theBulletin for wider details).
GENERAL LAW
Standards Board for England (Abolition) Order 2012,
SI 2012/668 – in force 1 April 2012
This Order makes provision in connection with the abolition of the Stand-ards Board for England on the abolition date of 1 April 2012.
MEDICINES
NEW LEGISLATION
Medicines (Products for Human Use) (Fees)
Regulations 2012, SI 2012/504 – in force 1 April 2012
These Regulations were made under the Medicines Act 1971, the EuropeanCommunities Act 1972 and the Finance Act 1973. They apply to England,Wales, Scotland and Northern Ireland and are to be interpreted in accord-ance with Sch 1. They revoke and re-enact in with some amendments theMedicines (Products for Human Use) (Fees) Regulations 2012, SI 2010/551.
They make amendments to the Medicines (Homoeopathic Medicinal Prod-ucts for Human Use) Regulations 1994, SI 1994/105 and the Medicines forHuman Use (Clinical Trials) Regulations 2004, SI 2004/1031. They makeprovision for the fees payable under the Medicines Act 1971 and other feespayable in respect of EU obligations relating to marketing authorizations,licences and certificates in respect of medicinal products for human use. Ingeneral the Regulations provide for fee reductions in some areas, simplifica-tion measures and amendments to facilitate better administrative practice.
Parts 2 to 9, 11 and 12 together with Schs 2 and 3 provide for capital fees tobe payable in connection with pre-application meetings; applications for, orvariations to, marketing authorizations, manufacturer’s licences, wholesaledealer’s licences, clinical trial authorisations, traditional herbal registrationsand certificates permitting the export of medicinal products; assistance inobtaining or renewing marketing authorizations in other EEA States; the Letterpart Ltd – Typeset in XML ❄ Tel: 01737 223329 ❄ e-mail: sales@letterpart.com
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MEDICINES
assessment of labels and leaflets; renewals of certain manufacturer’s licences;and inspections. The Regulations also: provide a ten per cent reduction in fees for applications under decen-tralised procedure where the UK is the reference member state; simplify the fee structure for capital fees payable for authorizations,licenses, registrations and certificates so that there is no price differen-tial between applications made electronically and others.
Part 10 and Sch 4 provide for periodic fees in connection with authorizations,registrations and licenses. Schedule 4 includes amendments to: clarify how the total value of products sold or supplied is to bedetermined; introduce a “lower fee” in respect of periodic fees for prescription onlymedicines; replace the three types of periodic fees previously payable in connectionwith pharmacy or general sale medicines with a single fee set at thesame level as the lower fee for prescription only medicines; replace the three types of periodic fees for parallel import licenses witha single fee; provide a single fee rate for herbal, homoeopathic and traditionalherbal medicinal products licences.
Part 13 and Sch 5 provides for fees in relation to homoeopathic medicinalproducts. In particular, the fee provisions from the Homoeopathic Regula-tions have been consolidated into these Regulations.
Part 14 and Schs 6, 7 and 8 deal with the time for payment and waiver orrefund of both capital and periodic fees in specified circumstances. TheRegulations make provision for payments to be made in advance of anyapplication or the fee becoming due to the licensing authority.
Part 15 makes consequential amendments to: the Clinical Trials Regulations to update cross-references to theseRegulations; the Homoeopathic Regulations to remove some obsolete definitionsfrom those regulations.
Part 16 revokes and makes savings provisions in relation to: earlier Regulations relating to fees for medicinal products for humanuse; parts of the Homoeopathic Regulations.
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MEDICINES
ENFORCEMENT
Custody for Unlawful Possession of Medicines
On 21 March 2012, a 35-year-old Wembley man, Mariusz Lewandowski,received a nine-month suspended prison sentence, was ordered to complete150 hours of unpaid community work and to pay £500 towards prosecutioncosts. He appeared at Harrow Crown Court after pleading guilty to sixcharges including the unlawful possession/ possession with intent to sell,distribution and sale of fake erectile dysfunction drugs including Cialis andViagra, as well as the supply and online advertising of the unlicensedmedicine, Kamagra. He pleaded guilty to six offences on 27 January 2012under the Medicines Act 1968, the Medicines (Advertising) Regulations 1994,SI 1994/1932, the Medicines for Human Use (Marketing Authorisations etc)Regulations 1994, SI 1994/3144, and s 92 of the Trade Marks Act 1994.
These included selling medicinal products, advertising medicinal products,two counts of Trade Mark offences and two counts of possession of amedicinal product for a business purpose (with the intention to sell it to anend user). As part of an MHRA investigation, test purchases had been madeof “Original Blue Pills” listed on an Ebay account. Analysis of these tabletsby MHRA laboratories found the product to be counterfeit. Lewandowski’sillicit business was taken down during the International Internet Week ofAction in September 2011, an international enforcement operation crackingdown on the illegal pharmaceutical trade. A warrant of entry was obtained,his premises being raided on 16 September 2011 which uncovered quantitiesof counterfeit Viagra, Cialis, Kamagra and Stud 100 (Lidocaine) to the valueof approximately £6,400.
Fake Medicines Seized in International Raids
A man and a woman have been arrested in Hartlepool and several thousandfake medicine tablets have been seized worth around £115,000 after raids bythe Medicines and Healthcare products Regulatory Agency. The blisterpacked tablets included counterfeit Viagra, Cialis and Levitra. In addition,other illegal generic versions of Viagra, Cialis and the withdrawn anti-obesitymedicines rimonabant and sibutramine were found. In a joint operation,known as “Operation Tribulus”, led by Spanish police and coordinated byEuropol, six people in total were been arrested and almost 300,000 doses offake medication seized. Police in Spain arrested four people as part of aninternational operation lasting several months. Those arrested are thought tobe part of a criminal gang importing fake medicines from Asia, mainly Chinaand Singapore, and distributing them via the internet to customers through-out Europe. See MHRA website for further details.
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INFORMATION
European Medicines Agency – Updated Mandatory
Article 57(2) Requirements for Marketing
Authorisation Holders
The European Medicines Agency has published an updated set of mandatoryrequirements for marketing authorisation holders to comply with art 57(2),one of the key measures of the new pharmacovigilance legislation. EMA hasreduced considerably the number of data fields initially required, therebyreducing the administrative burden and helping marketing authorisationholders to meet their legal deadline of 2 July 2012.
MHRA Learning Package on Opioids
MHRA have launched a learning module on opioids for clinical practition-ers. This self-directed learning package outlines the key risks of this impor-tant class of medicines. For each adverse effect, the package outlines: specific treatment for the adverse effect.
Self-assessment questions, together with full feedback, complements thelearning material. Interspersed in the content, clinicians will find ‘activities’to help consolidate the learning. Included is a short evaluation form at theend of the module for use in shaping MHRA learning modules. The learningpackage is suitable for doctors, pharmacists and nurses involved in the care ofpatients requiring treatment with an opioid medicine.
NEW LEGISLATION
Tobacco Advertising and Promotion (Display and
Specialist Tobacconists) (England) (Amendment)
Regulations 2012, SI 2012/677 – in force 6 April 2012 &
6 April 2015
These Regulations were made under the Tobacco Advertising and PromotionAct 2002, coming into force on 6 April 2012 for the purpose of theamendments of the Display Regulations for the purpose of large shops otherthan bulk tobacconists and 6 April 2015 for the purpose of amendments ofthe Specialist Tobacconist Regulations.
They amend the Tobacco Advertising and Promotion (Display) (England)Regulations 2010, SI 2010/445 (the “Display Regulations”) and the TobaccoAdvertising and Promotion (Specialist Tobacconists) (England) Regula-tions 2010, SI 2010/446 (the “Specialist Tobacconist Regulations”). The Letterpart Ltd – Typeset in XML ❄ Tel: 01737 223329 ❄ e-mail: sales@letterpart.com
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Display Regulations provide for exemptions from the prohibition of tobaccodisplays imposed by s 7A(1) of the Tobacco Advertising and PromotionAct 2002 (“the Act”). Regulation 2 amends the Display Regulations byincreasing the size of temporary display permitted in consequence of a“requested display” under the Act; and by extending the exemption fortemporary displays during restocking to further activities carried out in thenormal course of business. It also inserts into the Display Regulations arequirement for the Secretary of State to review the operation and effect ofthe Display Regulations and publish a report within five years after theycome fully into force and within every five years after that. Following areview it will fall to the Secretary of State to consider whether the DisplayRegulations should remain as they are, or be revoked or be amended. Afurther instrument would be needed to revoke the Display Regulations or toamend them.
The Specialist Tobacconist Regulations make provision for exemptions inrelation to specialist tobacconists from the prohibition of tobacco advertise-ments imposed by s 2 of the Act and the prohibition of tobacco displaysimposed by s 7A of the Act. Regulation 3 corrects a minor error in theseRegulations in relation to the required content of permitted tobacco adver-tisements; and inserts into the Specialist Tobacconist Regulations a require-ment for the Secretary of State to review the operation and effect of theSpecialist Tobacconist Regulations and publish a report within five yearsafter they come fully into force and within every five years after that.
Following a review it will fall to the Secretary of State to consider whetherthe Specialist Tobacconist Regulations should remain as they are, or berevoked or be amended. A further instrument would be needed to revoke theSpecialist Tobacconist Regulations or to amend them.
NEW EU LEGISLATION
Tobacco Products – Commission Directive 2012/9
(OJ No L 69; 8.3.2012)
This Directive replaces Annex I to Directive 2001/37 on the approximation ofthe laws, regulations and administrative provisions of the Member Statesconcerning the manufacture, presentation and sale of tobacco products. Itentered into force on 5April 2012, though member states may decide to allowthe continuation of marketing of products not complying with the provisionsof this Directive until 28 March 2016.
Toy Safety – Commission Directive 2012/7 (OJ No L 64;
3.3.2012)
This Directive amends Pt III of Annex II to Directive 2009/48 relating to toysafety, replacing the entry for “cadmium”. It enters into force on 23 March2012. Member states shall adopt and publish their implementing laws by20 January 2013 and apply them from 20 July 2013.
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Tobacco Products – Commission Directive 2012/9
(OJ No L 69; 8.3.2012)
This Directive replaces Annex I to Directive 2001/37 on the approximation ofthe laws, regulations and administrative provisions of the member statesconcerning the manufacture, presentation and sale of tobacco products. Itentered into force on 5 April 2012, though member states may decide to allowthe continuation of marketing of products not complying with the provisionsof this Directive until 28 March 2016.
Electronic Instructions for Medical Devices –
Regulation 207/2012 (OJ No L 72; 10.3.2012)
This Regulation establishes the conditions under which the instructions foruse of medical devices referred to in point 15 of Annex 1 to Directive 90/385and in point 13 of Annex I to Directive 93/42 may be provided in electronicform instead of in paper form. It also establishes certain requirementsconcerning instructions for use in electronic form which are provided inaddition to complete instructions for use in paper form relating to theircontents and websites. It entered into force on 30 March 2012 and appliesfrom 1 March 2013.
Low Voltage Equipment – Commission Communication
(OJ No C 61/56; 29.2.2012)
This Communication addresses electrical equipment designed for use withincertain voltage limits. It extends to 92 pages.
Wet grip Grading of Tyres – Commission
Communication (OJ No C 86/3; 23.3.2012)
This Communication addresses the implementation of Regulation 1235/2011amending Regulation 1222/2009 with regard to the wet grip grading of tyres,the measurement of rolling resistance and the verification procedure. Itpublishes the reference laboratories for the purpose of the alignment proce-dure concerning the measurement of rolling resistance of tyres.The laborato-ries are part of a network of laboratories which comply with therequirements set in point 3 of Annex IVa of Regulation (EC) No 1222/2009.
INFORMATION
“Red Tape Challenge”
The government is consulting on the removal of legislation regarded asoutdated or obsolete. The proposals identify the following as possible candi-dates for repeal or revocation: Pyrotechnic Articles (Safety) Regulations 2010, SI 2012/1554; Letterpart Ltd – Typeset in XML ❄ Tel: 01737 223329 ❄ e-mail: sales@letterpart.com
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Children’s Clothing (Hood Cords) Regulations 1976, SI 1976/2; Imitation Dummies (Safety) Regulations 1993, SI 1993/2923; Wheeled Child Conveyances (Safety) Regulations 1997, SI 1997/2866; Gas cooking Appliances (Safety) Regulations 1989, SI 1989/149; Heating Appliances (Fireguards) Regulations 1991, SI 1991/2693; Gas Catalytic Heaters (Safety) Regulations 1984, SI 1984/1802; All-Terrain Motor Vehicle (Safety) Regulations 1989, SI 1989/2288; Cooking Utensils (Safety) Regulations 1972, SI 1972/1957; Indication of Prices (Beds) Order 1978, SI 1978/1716.
In addition to the above regulations for revocation BIS are proposing to usethis consultation to seek agreement to reduce the age at which ChristmasCrackers can be legally purchased from 16 to 12 years old. This also arosefrom the Red Tape Challenge with retailers commenting on the extra burdenthe current law puts on them.
The consultation also looks at previously revoked regulations which will beremoved from the statute book: Child Resistant Packaging and Tactile Danger Warning (Safety) (Revo-cation) Regulations 1992, SI 1992/2620; Magnetic Toys (Safety) (Revocation) Regulations 2009, SI 2009/1347.
Responses to this consultation will be used to finalise decisions regarding theremoval or retention of these regulations. A government response to thisconsultation, outlining which regulations are to be removed and which are tobe retained as a result of evidence gathered through this consultation, will bepublished within three months of this consultation closing on 16 May 2012.
Where regulations are to be removed, this will have effect from 1 October2012. The website is available at www.redtapechallenge.cabinetoffice.gov.uk WEIGHTS & MEASURES
NEW LEGISLATION
Measuring Instruments (EEC Requirements) (Fees)
(Amendment) Regulations 2012/751 – in force 6 April
2012
These Regulations were made under the Finance Act 1973 and apply to theUnited Kingdom. They amend the Measuring Instruments (EEC Require-ments) (Fees) Regulations 2004, SI 2004/1300 which prescribe the fees to be Letterpart Ltd – Typeset in XML ❄ Tel: 01737 223329 ❄ e-mail: sales@letterpart.com
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ENVIRONMENTAL
charged in relation to certain services provided by the Secretary of State withregards to measuring instruments. The 2004 Regulations provide for the feespayable to the Secretary of State to be made up of a number of components,one of which is a “variable fee” calculated in accordance with Sch 1 to thoseRegulations. One of the components of the variable fee is an hourly rate.
Different hourly rates are prescribed depending on the work done and theseniority of the staff involved. These Regulations increase the hourly rates forspecified types of work by £5. The 2004 Regulations were amended by theMeasuring Instruments (EEC Requirements) (Fees) (Amendment) Regula-tions 2010, SI 2010/728 which resulted in the removal of the permission tocharge customers for travel costs in Great Britain relating to the approval of amanufacturer’s quality system and the carrying out of EC surveillance. TheseRegulations reverse the effect of the 2010 Regulations.
INFORMATION
National Measurement Office Information
The following instruments have had their National and MID GuidanceNotes consolidated into one document as follows: Automatic Catchweighing Instruments; Beltweighers; Capacity Measuresand Testing Cold Water Meters; Liquid Fuel & Lubricants; Road Tankers.
ENVIRONMENTAL
Environmental Protection Act 1990 (Commencement
No 19) Order 2012, SI 2012/898 – in force 1.4.20
This Commencement Order applies to England and Wales only.
Ecodesign for Air conditioners and Fans –
Regulation 206/2012 (OJ No L 72; 10.3.2012)
This Regulation implements Directive 2009/125 on ecodesign requirementsfor air conditioners and comfort fans. It establishes eco-design requirementsfor the placing on the market of electric mains-operated air conditioners witha rated capacity of ≤ 12 kW for cooling, or heating if the product has nocooling function, and comfort fans with an electric fan power input ≤125W. Itdoes not apply to: appliances that use non-electric energy sources; air conditioners of which the condenser-side or evaporator- side, orboth, do not use air for heat transfer medium.
It entered into force on 1 August 2012 and applies from 1 January 2013.
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