(1)

Regulation (EC) No 689/2008 implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade, signed on 11 September 1998 and approved, on behalf of the Community, by Council Decision 2003/106/EC (2).

(2)

Annex I to Regulation (EC) No 689/2008 should be amended to take into account regulatory action in respect of certain chemicals taken pursuant to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (4) and Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (5).

(3)

The substances ethalfluralin, indolylacetic acid and thiobencarb have not been included as active substances in Annex I to Directive 91/414/EEC, with the effect that those active substances are banned for pesticide use and thus should be added to the lists of chemicals contained in Parts 1 and 2 of Annex I to Regulation (EC) No 689/2008.

(4)

The substance guazatine has not been included as an active substance in Annex I to Directive 91/414/EEC and guazatine, as referred to as guazatine triacetate, has not been included as an active substance in Annex I, IA or IB to Directive 98/8/EC, with the effect that guazatine is banned for pesticide use and thus should be added to the lists of chemicals contained in Parts 1 and 2 of Annex I to Regulation (EC) No 689/2008. The addition of guazatine to Annex I was suspended due to a new application for inclusion in Annex I to Directive 91/414/EEC submitted pursuant to Article 13 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (6). This new application has been withdrawn by the applicant with the effect that the reason for suspending the addition to Annex I disappeared. Therefore, the substance guazatine should be added to the lists of chemicals contained in Parts 1 and 2 of Annex I to Regulation (EC) No 689/2008.

(5)

The substance 1,3-dichloropropene has not been included as an active substance in Annex I to Directive 91/414/EEC, with the effect that 1,3-dichloropropene is banned for pesticide use and thus should be added to the lists of chemicals contained in Parts 1 and 2 of Annex I to Regulation (EC) No 689/2008. The addition of 1,3-dichloropropene to Part 2 of Annex I was suspended due to a new application for inclusion in Annex I to Directive 91/414/EEC submitted pursuant to Article 13 of Regulation (EC) No 33/2008. This new application resulted again in the decision not to include the substance 1,3-dichloropropene as an active substance in Annex I to Directive 91/414/EEC with the effect that 1,3-dichloropropene remains banned for pesticide use and that the reason for suspending the addition to Part 2 of Annex I disappeared. Therefore, the substance 1,3-dichloropropene should be added to the list of chemicals contained in Part 2 of Annex I to Regulation (EC) No 689/2008.

(6)

The substance haloxyfop-P has been included as an active substance in Annex I to Directive 91/414/EEC, with the effect that haloxyfop-P is no longer banned for pesticide use. Consequently the active substance, as referred to as haloxyfop-R, should be deleted from Part 1 of Annex I to Regulation (EC) No 689/2008.

(7)

Annex I to Regulation (EC) No 689/2008 should therefore be amended accordingly.

(8)

In order to allow enough time for Member States and industry to take the measures necessary for the implementation of this Regulation, its application should be deferred.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133 of Regulation (EC) No 1907/2006,

(1)

Commission Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs (2) sets maximum levels for benzo(a)pyrene in a range of foodstuffs.

(2)

Benzo(a)pyrene belongs to the group of polycyclic aromatic hydrocarbons (PAH) and is used as a marker for the occurrence and effect of carcinogenic PAH in food based on a scientific opinion of the former Scientific Committee on Food (SCF) (3). In its opinion of December 2002, the SCF recommended that further analyses of the relative proportions of these PAH in foods would be necessary for a future review of the suitability of maintaining benzo(a)pyrene as a marker.

(3)

New data on occurrence of carcinogenic PAH in foodstuffs have been collected by the Member States in the framework of Commission Recommendation 2005/108/EC (4). The Commission asked the European Food Safety Authority (EFSA) to review the SCF opinion taking into account the new occurrence data, other relevant new scientific information as well as the Margin of Exposure (MOE) approach. Within this review, EFSA was asked to re-assess the suitability of maintaining benzo(a)pyrene as a marker.

(4)

The Scientific Panel on Contaminants in the Food Chain (CONTAM Panel) of EFSA adopted an opinion on Polycyclic Aromatic Hydrocarbons in Food on 9 June 2008 (5). In this opinion EFSA concluded that benzo(a)pyrene is not a suitable marker for the occurrence of polycyclic aromatic hydrocarbons in food and that a system of four specific substances (PAH4 (6)) or eight specific substances (PAH8 (7)) would be the most suitable indicators of PAH in food. EFSA also concluded that a system of eight substances (PAH8) would not provide much added value compared to a system of four substances (PAH4).

(5)

Furthermore, the CONTAM Panel concluded, using the Margin of Exposure (MOE) approach, that there is low concern for consumer health at the average estimated dietary exposures. However, for high level consumers the MOEs were close to or less than 10 000, which indicates a potential concern for consumer health.

(6)

Based on the conclusions of EFSA, the current system of using benzo(a)pyrene as the only marker for the group of polycyclic aromatic hydrocarbons, can not be maintained. An amendment of Regulation (EC) No 1881/2006 is therefore necessary.

(7)

New maximum levels for the sum of four substances (PAH4) (benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene) should be introduced, whilst maintaining a separate maximum level for benzo(a)pyrene.

(8)

Such system would ensure that PAH levels in food are kept at levels that do not cause health concern and that the amount of PAH can also be controlled in those samples in which benzo(a)pyrene is not detectable, but where other PAH are present.

(9)

The separate maximum level for benzo(a)pyrene is maintained to ensure comparability of previous and future data. After a certain time of implementation of this amendment and on basis of new data that will be generated in future, the need for retaining a separate maximum level for benzo(a) pyrene should be re-assessed.

(10)

As regards the sum of the four substances (PAH4), lower bound concentrations should be used as the basis for compliance decisions.

(11)

Maximum levels for polycyclic aromatic hydrocarbons must be safe and as low as reasonably achievable (ALARA) based upon good manufacturing and agricultural/fishery practices. The new PAH occurrence data show that background levels of PAH are lower than previously thought in some food commodities. Benzo(a)pyrene maximum levels have therefore been adapted to reflect more realistic lower background levels in fresh and smoked bivalve molluscs.

(12)

Data for smoked fish and smoked meat have also shown that lower maximum levels are achievable. Nevertheless, adaptations of current smoking technology may be necessary in some cases. Therefore, a two step procedure should be established for smoked meat and smoked fish which grants a transition of two years from the date of application of this Regulation before lower maximum levels become applicable.

(13)

Smoked sprats and canned smoked sprats have been found to contain higher levels of PAH than other smoked fish. Specific maximum levels should be established for smoked sprats and canned smoked sprats in order to reflect what is achievable in these foodstuffs.

(14)

Previously a maximum level for benzo(a)pyrene in "muscle meat of fish other than smoked fish" was established as an indicator for potential environmental pollution. Nevertheless, it has been shown that PAH are quickly metabolised in fresh fish and do not accumulate in the muscle meat. Therefore, maintaining a maximum level for PAH in fresh fish is no longer appropriate.

(15)

High levels of PAH have been found in some types of heat treated meat and heat treated meat products sold to the final consumer. These levels are avoidable if appropriate processing conditions and equipment are used. It is therefore appropriate to establish maximum levels for PAH in meat and meat products that have undergone a heat treatment process known to potentially result in formation of PAH, i.e. only grilling and barbecuing.

(16)

Cocoa butter was temporarily exempted from the existing maximum level for benzo(a)pyrene in oils and fats under Regulation (EC) No 1881/2006 and a review of the appropriateness of setting a maximum level for PAH in cocoa butter was foreseen by 1 April 2007. The review was then postponed pending the result of the then ongoing scientific re-assessment of PAH by EFSA.

(17)

Cocoa butter contains higher levels of PAH than other oils and fats. This is mainly due to inappropriate drying practices of the cocoa beans and the fact that cocoa butter can not be refined as other vegetable oils and fats. Cocoa butter is a main constituent of cocoa raw products (e.g. cocoa beans, cocoa mass, cocoa nibs or cocoa liquor) and is present in chocolate and other cocoa products often consumed by children. It thereby contributes to human exposure, in particular to exposure of children. It is therefore necessary to establish maximum levels for PAH in cocoa beans and derived products, thereby also including cocoa butter.

(18)

Maximum levels for PAH in cocoa beans should be established at levels as low as reasonably achievable and taking into account the current technological possibilities of producing countries. They should be established on a fat basis since PAH concentrate in the fat fraction, the cocoa butter. To allow producing countries to make technological improvements in order to adapt to these maximum levels, the date of application of the maximum levels for cocoa beans and derived products should be deferred. Furthermore, initially a higher maximum level for the sum of the four substances should apply to these products. After a transition period of two years a lower maximum level should apply. The levels of PAH in cocoa beans and derived products should be regularly monitored with a view to assessing the possibility for further decreasing the maximum levels in future.

(19)

Data have shown that coconut oil can contain higher amounts of PAH4 than other vegetable oils and fats. This is due to the proportionally higher presence of benz(a)anthracene and chrysene which can not be easily removed during refinement of coconut oil. Specific maximum levels for coconut oil should therefore be set at levels as low as reasonably achievable and taking into account the current technological possibilities of producing countries. As technological improvements in producing countries are expected, the levels of PAH in coconut oil should be regularly monitored with a view to assessing the possibility for setting lower levels in future.

(20)

Current occurrence data on PAH in cereals and vegetables are limited. The available data indicate that cereals and vegetables contain rather low levels of PAH. The low levels seen in the currently available occurrence data do not justify the immediate setting of maximum levels. Nevertheless, EFSA identified cereals and vegetables as being important contributors to human exposure due to their high consumption. Therefore, PAH levels in these two product groups should be further monitored. On the basis of further data, the need for setting maximum levels will be evaluated.

(21)

High levels of PAH have been found in some food supplements. Nevertheless, the levels are variable and depend on the specific type of food supplements. Further data on food supplements are needed and should be collected. Once these data become available, the need for setting maximum levels for PAH in food supplements will be evaluated.

(22)

Member States and food business operators should be allowed time to adapt to the maximum levels established by this Regulation. The date of application of this Regulation should therefore be deferred. A transitional period should be provided for the products already placed on the market before the date of application of the amendments introduced by this Regulation.

(23)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council have opposed them,

(1)

Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (2) established, inter alia, maximum levels for the contaminant benzo(a)pyrene.

(2)

The Scientific Panel on Contaminants in the Food Chain of the European Food Safety Authority (EFSA) adopted an opinion on Polycyclic Aromatic Hydrocarbons in Food on 9 June 2008 (3). The EFSA concluded that benzo(a)pyrene is not a suitable marker for the occurrence of polycyclic aromatic hydrocarbons (PAH) in food and that a system of four specific substances or eight specific substances would be the most suitable markers of PAH in food. The EFSA also concluded that a system of eight substances would not provide much added value compared to a system of four substances.

(3)

As a consequence Commission Regulation (EU) No 835/2011 (4) amended Regulation (EC) No 1881/2006 in order to set maximum levels for the sum of four polycyclic aromatic hydrocarbons (benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene).

(4)

Commission Regulation (EC) No 333/2007 (5) lays down analytical performance criteria only for benzo(a)pyrene. It is therefore necessary to lay down analytical performance criteria for the other three substances for which maximum levels are now set out in Regulation (EC) No 1881/2006.

(5)

The European Union Reference Laboratory for Polycyclic Aromatic Hydrocarbons (EU-RL PAH) in collaboration with the national reference laboratories carried out a survey among official control laboratories to assess which analytical performance criteria would be achievable for benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene in relevant food matrices. The outcome of this survey was summarised by the EU-RL PAH in the Report on ‘Performance characteristics of analysis methods for the determination of 4 polycyclic aromatic hydrocarbons in food’ (6). The results of the survey show that the analytical performance criteria currently applicable to benzo(a)pyrene are also suitable for the other three substances.

(6)

Experience acquired while implementing Regulation (EC) No 333/2007 revealed that in some cases the current sampling provisions may be impracticable or may lead to unacceptable economic damage to the sampled lot. For such cases, departure from the sampling procedures should be allowed, provided that sampling remains sufficiently representative of the sampled lot or sublot and that the procedure used is fully documented. For sampling at the retail stage, flexibility to depart from the sampling procedures existed already. The provisions for sampling at retail stage should be aligned with the general sampling procedures.

(7)

More detailed provisions are needed as regards the material of sampling containers when samples are taken for PAH analysis. Plastic containers are widely used by enforcement authorities, but they are not suitable when sampling is carried out for PAH analysis, as the PAH content of the sample can be altered by these materials.

(8)

Clarification is needed for some aspects of the specific requirements for analytical methods, in particular the requirements regarding the use of the performance criteria and the ‘fitness-for-purpose’ approach. Furthermore, the presentation of the tables with the performance criteria should be modified to appear more uniform across all analytes.

(9)

Regulation (EC) No 333/2007 should therefore be amended accordingly. Since Regulation (EU) No 835/2011 and this Regulation are inter-linked, both Regulations should become applicable on the same date.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council have opposed them,

(1)

the title is replaced by the following:

‘ Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and polycyclic aromatic hydrocarbons in foodstuffs ’;

(2)

in Article 1, paragraph 1 is replaced by the following:

(3)

the Annex is amended in accordance with the Annex to this Regulation.

(1)

Commission Regulation (EC) No 620/2009 of 13 July 2009 providing for the administration of an import tariff quota for high-quality beef (3) sets out detailed rules for the submission and issue of import licences.

(2)

Article 7(2) of Regulation (EC) No 1301/2006 provides that in cases where quantities covered by licence applications exceed the quantities available for the quota period, allocation coefficients should be fixed for the quantities covered by each licence application. The applications for import licences submitted pursuant to Article 3 of Regulation (EC) No 620/2009 between 1 and 7 August 2011 exceed the quantities available. Therefore, the extent to which import licences may be issued and the allocation coefficient should be determined,

(1)

On 28 September 2009 the company Cantox Health Science International on behalf of the company Enzymotec Ltd made a request to the competent authorities of Finland to place Phosphatidylserine from soya phospholipids on the market as novel food ingredient.

(2)

On 14 April 2010 the competent food assessment body of Finland issued its initial assessment report. In that report it came to the conclusion that the company Enzymotec has provided sufficient information to authorise the placing on the market of Phosphatidylserine from soya phospholipids as a novel food ingredient.

(3)

The Commission forwarded the initial assessment report to all Member States on 21 April 2010.

(4)

Within the 60 days-period laid down in Article 6(4) of Regulation (EC) No 258/97, one reasoned objection to the marketing of the product, which concerns the maximum daily intake, was raised in accordance with that provision. In accordance with the provisions of Article 6(4) a Commission implementing Decision is required that takes into account the reasoned objection raised.

(5)

Phosphatidylserine from soya phospholipids complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(6)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,