12 January - 20 June 2016

Legislation headlines

  • Draft initiative on reducing the presence of acrylamide in food
  • EFSA launch new support initiative for applicants from small and medium-sized enterprises (SMEs)
  • Commission notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene
  • Entering a name in the register of protected designations of origin (Ail violet de Cadours (PDO))
  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (Cornish Sardines (PGI))
  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (Connemara Hill Lamb/Uain Sléibhe Chonamara (PGI))
  • Entering a name in the register of protected geographical indications (Charolais de Bourgogne (PGI))
  • Entering a name in the register of protected geographical indications (Traditional Welsh Cider (PGI))
  • Entering a name in the register of protected geographical indications (Traditional Welsh Perry (PGI))
  • Application to enter ‘Fenalår fra Norge’ in the Register of Protected Geographical Indications
  • Authorisation of the use of butane (E 943a), isobutane (E 943b) and propane (E 944) as propellants in colour preparations
  • Approving the use of diphosphates, triphosphates and polyphosphates (‘phosphates’) as a stabiliser in a number of Czech meat preparations
  • Regarding the use of nitrites (E 249-250) in ‘golonka peklowana’
  • Approving the active substance Beauveria bassiana strain 147
  • “Welsh Laverbread” approved to enter the Register of Protected Designation of Origins
  • EFSA publishes advice on follow-on formulae with lower protein content
  • New food enzyme exposure tool – EFSA
  • Clearer guidance on plastic food contact materials
  • EFSA publish new guidance on infant and follow-on formula from protein hydrolysates
  • Amending the Annex on protective measures in relation to outbreaks avian influenza – UK
  • Application to enter a name in the register of protected designation of origin ‘Porc noir de Bigorre’ (PDO)
  • Application to enter a name in the register of protected designation of origin ‘Jambon noir de Bigorre’ (PDO)
  • Entering a name in the register of protected designations of origin ‘Stupavské Zelé’
  • Amendment to the application to ‘Acciughe Sotto Sale Del Mar Ligure’ to enter the register of protected geographical indications
  • Renewing the approval of the active substance flazasulfuron
  • Amending the definitions of fishmeal and fish oil
  • Withdrawing the approval of the active substance methyl nonyl ketone
  • Scientific opinions

Draft initiative on reducing the presence of acrylamide in food
The European Commission has published a draft initiative to control and mitigation measures to reduce the presence of acrylamide in food.  The draft act, which is open for feedback, states given the EFSA’s “conclusions with respect to carcinogenic effects of acrylamide and in the absence of any consistent and mandatory measures to be applied by food businesses in order to lower levels of acrylamide, it is necessary to ensure food safety and to reduce the presence of acrylamide in foodstuffs where raw materials contain its precursors by laying down appropriate mitigation measures. The levels of acrylamide can be lowered by mitigation approach, such as implementation of good hygiene practice and application of procedures based on hazard analysis and critical control point (HACCP) principles.”  The proposal lays down a number of mitigation measures that food business operators must follow in order to reduce the amount of acrylamide in food including sampling and analysis.

RSSL can help manufacturers reduce acrylamide by offering an analysis service that can determine where and when acrylamide is generated in the production process. By carrying out this survey routinely (many clients opt for an annual assessment), RSSL can help manufacturers understand which parts of the process could be adjusted to reduce acrylamide formation. RSSL's service has UKAS accreditation for biscuits, but the same methods are equally applicable to all affected foods. The sample preparation is often complex, and the LC-MS techniques used in detection/quantification are highly sophisticated and capable of detecting acrylamide at levels down to 50ng/g. For more information please contact Customer Services on +44 (0) 118 918 4076 or email enquiries@rssl.com

EFSA launch new support initiative for applicants from small and medium-sized enterprises (SMEs)
EFSA has launched a new support initiative for applicants from small and medium-sized enterprises (SMEs). In the next six month, SMEs in the areas of feed additives and novel foods (excluding traditional food) can request an administrative check of their draft dossiers prior to submission. The support will be provided via teleconferences.

RSSL can help you with your novel food and regulatory submission by providing analytical and informal sensory data for inclusion in your regulatory scientific dossiers.  For more information please contact Customer Services on +44 (0) 118 918 4076 or email enquiries@rssl.com

Commission notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene
In the aftermath of a VTEC crisis in 2011, the Commission asked the European Food Safety Authority (EFSA) to advice on the public health risks posed by pathogens in food of non-animal origin (FNAO), addressing in particular the risk factors and the mitigation options including possible microbiological criteria. As a result, EFSA issued six scientific opinions on a number of food/pathogen combinations identified as the most important risks within FNAO.  This guideline takes account of the relevant opinions of EFSA, and consultation with Member States experts and relevant stakeholders. Though it is intended to offer practical help to growers, it may also be used by official inspectors during their audits where appropriate. EFSA confirmed that further research on possible risks and risk mitigating measures related to FFV should continue.

Entering a name in the register of protected designations of origin (Ail violet de Cadours (PDO))
France's application to register the name ‘Ail violet de Cadours’ was published in the Official Journal of the European Union and as no statements of opposition has been received it the name Ail violet de Cadours has now been entered into the register of protected designations of origin

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (Cornish Sardines (PGI))
The Commission has examined the United Kingdom's application for the approval of amendments to the specification for the protected geographical indication ‘Cornish Sardines’, registered under Commission Regulation (EC) No 1182/2009.  As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved.

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (Connemara Hill Lamb/Uain Sléibhe Chonamara (PGI))
The Commission has examined Ireland's application for the approval of amendments to the specification for the protected geographical indication ‘Connemara Hill Lamb’/‘Uain Sléibhe Chonamara’ and as no statement of objectives was received the commission has approved the amendments.

Entering a name in the register of protected geographical indications (Charolais de Bourgogne (PGI))
France's application to register the name ‘Charolais de Bourgogne’ was published in the Official Journal of the European Union.

Entering a name in the register of protected geographical indications (Traditional Welsh Cider (PGI))
The United Kingdom's application to register the name ‘Traditional Welsh Cider’ was published in the Official Journal of the European Union.  As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Traditional Welsh Cider’ should therefore be entered in the register.

Entering a name in the register of protected geographical indications (Traditional Welsh Perry (PGI))
The United Kingdom's application to register the name ‘Traditional Welsh Perry’ was published in the Official Journal of the European Union. As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Traditional Welsh Perry’ should therefore be entered in the register.

Application to enter ‘Fenalår fra Norge’ in the Register of Protected Geographical Indications
Norway have applied to get ‘Fenalår fra Norge’ entered in the Register of Protected Geographical Indications.  ‘Fenalår fra Norge’ is salted, dried and matured, and sometimes smoked, leg of lamb and mutton of Norwegian origin. ‘Fenalår fra Norge’ comprises the varieties ‘Traditional’ and ‘Matured’. ‘Fenalår fra Norge’ includes whole items and completely or partially boned items. The hooves and lower part of the leg are generally completely or partially removed.

Authorisation of the use of butane (E 943a), isobutane (E 943b) and propane (E 944) as propellants in colour preparations
Butane, isobutane and propane used as propellants can produce the necessary pressure to expel colour preparations from a spray in order to obtain an appropriate homogenous coverage of colours on foods. Since the authorisation of use of butane (E 943a), isobutane (E 943b) and propane (E 944) as propellants in colour preparations constitutes an update of that list which is not liable to have an effect on human health, it was not necessary to seek the opinion of the EFSA. Therefore, it is appropriate to authorise the use of butane (E 943a), isobutane (E 943b) and propane (E 944) as propellants in colour preparations of groups II and III, as defined in Part C of Annex II to Regulation (EC) No 1333/2008.

Approving the use of diphosphates, triphosphates and polyphosphates (‘phosphates’) as a stabiliser in a number of Czech meat preparations
An application was submitted by the Czech Republic for the authorisation of the use of phosphoric acid, phosphates, diphosphates, triphosphates and polyphosphates (‘phosphates’) as a stabiliser in the following Czech meat preparations: Bílá klobása, Vinná klobása, Sváteční klobása and Syrová klobása. The use of phosphates is required to maintain the physico-chemical state and to increase the binding capacity of meat preparations. Their safety was evaluated by the Scientific Committee for Food which established the Maximum Tolerable Daily Intake of 70 mg/kg body weight expressed as phosphorus. Since the application for the extension of use of phosphates is limited to a few specific products that have been traditionally used it is not expected that the extension will have a significant impact on the overall exposure to phosphates. Therefore, the extended use of these additives constitutes an update of the Union list which is not liable to have an effect on human health and it is not necessary to seek the opinion of the EFSA. Annex II to Regulation (EC) No 1333/2008 should be amended accordingly.

Entering a name in the register of protected geographical indications (Kopi Arabika Gayo (PGI))
Indonesia's application to register the name ‘Kopi Arabika Gayo’ was published in the Official Journal of the European Union.  As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Kopi Arabika Gayo’ should therefore be entered in the register,

Regarding the use of nitrites (E 249-250) in ‘golonka peklowana’
On 10 March 2016 an application was submitted by Poland for the authorisation of the use of nitrites (E 249-250) as a preservative in ‘golonka peklowana’. According to the applicant ‘golonka peklowana’ is a traditional Polish meat preparation in which nitrites apart from their preserving effect are used as a curing agent to achieve the desired colour, flavour and texture properties as expected by the consumers. ‘Golonka peklowana’ is offered to the consumers to be further heat-treated before consumption. Nitrites are authorised for the use in meat products on a general basis, the use in meat preparations is restricted to certain traditional preparations and specific provisions are laid down for traditionally cured meat products. Since the application for the extension of use of nitrites is limited to the specific meat preparation that has been traditionally used it is not expected that the extension will have a significant impact on the overall exposure to nitrites. Therefore, the extended use of these additives constitutes an update of the Union list which is not liable to have an effect on human health and it is not necessary to seek the opinion of the EFSA.  Therefore the useof nitrites in Golonka peklowana has been approved and Annex II to Regulation (EC) No 1333/2008 should be amended accordingly.

Approving the active substance Beauveria bassiana strain 147
France received on 6 November 2012 an application from Arysta Lifescience SAS for the approval of the active substance Beauveria bassiana strain 147. The active substance has been approved although there are certain conditions and restrictions.

“Welsh Laverbread” approved to enter the Register of Protected Designation of Origins
The United Kingdom's application to register the name ‘Welsh Laverbread’ was published in the Official Journal of the European Union.  As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Welsh Laverbread’ should therefore be entered in the register.

EFSA publishes advice on follow-on formulae with lower protein content
Follow-on formula with a protein content of at least 1.6 g/100 kcal made from either cow or goat’s milk is safe and suitable for infants living in Europe, EFSA says. Current EU legislation sets the minimum protein content at 1.8 g/100kcal.

New food enzyme exposure tool – EFSA
EFSA scientists have devised a way to more accurately estimate consumer exposure to enzymes used in food production, improving their safety evaluation as required by EU law. The exposure tool can be tailored to each food process involving food enzymes. It uses technical conversion factors, which means we can combine food consumption data with enzyme use levels and take into account the level of transfer of food enzymes into food products.

Clearer guidance on plastic food contact materials
EFSA have published updated guidance which provides applicants with clearer advice on how to submit dossiers on plastic food contact materials before they can be put on the market in the European Union. Previously covered in one guidance document, EFSA has now published separate scientific and administrative documents.

EFSA publish new guidance on infant and follow-on formula from protein hydrolysates
New guidance published by EFSA will assist applicants in preparing and presenting dossiers for authorisation of infant and/or follow-on formulae manufactured from protein hydrolysates. It will also help applicants in preparing dossiers to assess a product’s efficacy in reducing the risk of infants becoming allergic to milk proteins.

Amending the Annex on protective measures in relation to outbreaks avian influenza – UK
Commission Implementing Decision (EU) 2017/247 was adopted following outbreaks of highly pathogenic avian influenza of subtype H5 in a number of Member States (‘the concerned Member States’), and the establishment of protection and surveillance zones by the competent authority of the concerned Member States in accordance with Council Directive 2005/94/EC.  While there has been a significant improvement in the epidemiological situation in the Union as regards highly pathogenic avian influenza, since the date of the last amendments made to Implementing Decision (EU) 2017/247 by Implementing Decision (EU) 2017/780, the United Kingdom has notified the Commission of further outbreaks of highly pathogenic avian influenza of subtype H5 in holdings located outside the areas currently listed in the Annex to Implementing Decision (EU) 2017/247 for that Member State. The Commission has examined the measures taken by the United Kingdom in accordance with Directive 2005/94/EC, following the latest outbreaks of avian influenza of subtype H5 and it has satisfied itself that the boundaries of the protection and surveillance zones, are at a sufficient distance to any holding where an outbreak of highly pathogenic avian influenza of subtype H5 has been confirmed. In order to prevent any unnecessary disturbance to trade within the Union and to avoid unjustified barriers to trade being imposed by third countries, it is necessary to rapidly describe at Union level, in collaboration with the United Kingdom, the new protection and surveillance zones established in that Member State in accordance with Directive 2005/94/EC.

Application to enter a name in the register of protected designation of origin ‘Porc noir de Bigorre’ (PDO)
France have applied for ‘Porc noir de Bigorre’ to enter the register of protected designation of origin.  ‘Porc noir de Bigorre’ meat comes from pure bred male and female Gascon pigs reared for slaughter, with slaughter being performed at an age of at least 12 months and no more than 24 months.

Application to enter a name in the register of protected designation of origin ‘Jambon noir de Bigorre’ (PDO)
France have applied for ‘Jambon noir de Bigorre’ to enter the register of protected designation of origin.  ‘Jambon noir de Bigorre’ is a dried ham made from pure bred local Gascon pigs, reared in grassy paddocks from the age of six months and slaughtered at an age of at least 12 months and no more than 24 months.

Entering a name in the register of protected designations of origin ‘Stupavské Zelé’
Slovakia's application to register the name ‘Stupavské Zelé’ was published in the Official Journal of the European Union.  As no statement of opposition was received the name ‘Stupavské Zelé’ has entered the register of protected designations of origin.

Amendment to the application to ‘Acciughe Sotto Sale Del Mar Ligure’ to enter the register of protected geographical indications
Italy have made amendments to their application for ‘Acciughe Sotto Sale Del Mar Ligure’.  The Protected Geographical Indication (PGI) ‘Acciughe sotto sale del Mar Ligure’ is reserved for the product obtained from the anchovies fished, processed and preserved in salt. Amendments have be made to the products description, geographical area, proof of origin, production method, and labelling.

Renewing the approval of the active substance flazasulfuron
The approval of the active substance flazasulfuron, expires on 31 January 2018. On 10 August 2016 the EFSA communicated to the Commission its conclusion on whether flazasulfuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. It has been established with respect to one or more representative uses of at least one plant protection product containing flazasulfuron that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of flazasulforon.

Amending the definitions of fishmeal and fish oil
Fishmeal is defined in point 7 of Annex I to Regulation (EU) No 142/2011 as processed animal protein derived from aquatic animals, except sea mammals. The definition of fish oil, which is a product of the same technological process as fishmeal, is provided for in point 9 of that Annex. The commission note that as the use of processed animal proteins from wild aquatic animals, such as starfish, and farmed aquatic invertebrates other than molluscs and crustaceans in feed for non-ruminant animals does not represent a higher risk than the use of fishmeal in such feed, it is appropriate to modify the definitions of ‘fishmeal’ and ‘fish oil’ in order to include certain aquatic invertebrate animals. Point 7 is replaced by the following: “fishmeal” means processed animal protein derived from aquatic animals except sea mammals, including farmed aquatic invertebrates, including those covered by Article 3(1)(e) of Council Directive 2006/88/EC (*1), and starfish of the species Asterias rubens which are harvested in a mollusc production area.  Point 9 has been replaced by the following:          “fish oil” means oil derived from the processing of aquatic animals except sea mammals, including farmed aquatic invertebrates, including those covered by Article 3(1)(e) of Directive 2006/88/EC, and starfish of the species Asterias rubens which are harvested in a mollusc production area, or oil from the processing of fish for human consumption, which an operator has destined for purposes other than human consumption.

Withdrawing the approval of the active substance methyl nonyl ketone
Commission Directive 2008/127/EC included methyl nonyl ketone as an active substance in Annex I to Council Directive 91/414/EEC. The notifier failed to submit the confirmatory information on a number of points and also failed to reply to the letter from the Commission giving him the opportunity to explain his position before any decision to withdraw the substance would be taken.  Consequently, it is appropriate to withdraw the approval of methyl nonyl ketone.

Scientific opinions

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