title: Commission Implementing Regulation (EU) No 995/2012 of 26 October 2012 laying down detailed rules for the implementation of Decision No 1608/2003/EC of the European Parliament and of the Council concerning the production and development of Community statistics on science and technology  Text with EEA relevance

text:
               27.10.2012

               EN

               Official Journal of the European Union

               L 299/18

         COMMISSION IMPLEMENTING REGULATION (EU) No 995/2012
   of 26 October 2012
   laying down detailed rules for the implementation of Decision No 1608/2003/EC of the European Parliament and of the Council concerning the production and development of Community statistics on science and technology
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Decision No 1608/2003/EC of the European Parliament and of the Council of 22 July 2003 concerning the production and development of Community statistics on science and technology (1) and in particular Article 3 thereof,
   Whereas:

               (1)

               In order to take into account the developments in the area of statistics on science and technology, as well as requests for new and more detailed and frequent statistics, new implementing measures of Decision No 1608/2003/EC should be laid down.

               (2)

               Existing statistical support for decisions in current policy areas should be continued and additional requirements arising from new policy initiatives should be satisfied, with a view to making best use of available resources and minimising the response burden.

               (3)

               Regulation (EC) No 223/2009 of the European Parliament and of the Council (2) on European statistics provides a reference framework, in particular with regard to rules on access to administrative data sources and statistical confidentiality.

               (4)

               It is necessary to ensure that European statistics on science and technology are consistent with other international standards. To that end, work carried out by the Organisation for Economic Cooperation and Development (OECD) and other international organisations should be taken into account. In particular, the Frascati Manual on research and development statistics, the Canberra Manual on statistics on human resources devoted to science and technology, the OECD Patent Statistics Manual, published by the OECD, as well as the Oslo Manual on innovation statistics, published jointly by the OECD and the European Commission (Eurostat), should provide a reference framework.

               (5)

               For the sake of clarity, Commission Regulation (EC) No 753/2004 of 22 April 2004 implementing Decision No 1608/2003/EC of the European Parliament and of the Council as regards statistics on science and technology (3) and Commission Regulation (EC) No 1450/2004 of 13 August 2004 implementing Decision No 1608/2003/EC of the European Parliament and of the Council concerning the production and development of Community statistics on innovation (4) should be repealed.

               (6)

               The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee,

         HAS ADOPTED THIS REGULATION:
   Article 1
   This Regulation lays down detailed rules concerning the production of European statistics on science and technology.
   Article 2
   1.   This Regulation shall cover the following domains:

               (a)

               statistics on research and development (R & D);

               (b)

               statistics on government budget appropriations or outlays on research and development (GBAORD);

               (c)

               innovation statistics;

               (d)

               statistics on human resources in science and technology, including gender and mobility statistics, statistics on patents, statistics on high-technology industries and knowledge-based services and other statistics on science and technology.

         The lists of statistical variables, the activities and sectors covered, breakdowns of the results, frequency, deadlines for data provision and the reference period shall be as specified in Annexes I and II.
   For the domains referred to in point (d) of first subparagraph, the necessary data shall be obtained from existing statistical or other data sources, as specified in section 3 of Annex I.
   2.   The lists of statistical variables, the activities and sectors covered, breakdowns of the results, frequency, deadlines for data provision, and other characteristics set out in Annexes I and II shall, where appropriate, be reviewed at regular intervals.
   Article 3
   Member States shall acquire the necessary data using a combination of different sources, such as sample surveys, administrative data sources or other data sources. As far as the quality or statistical estimation procedures are concerned, the other data sources shall be at least equivalent to sample surveys or administrative data sources.
   Article 4
   The statistics referred to in Annexes I and II shall be based on harmonised concepts and definitions, notably those contained in the most recent versions of the Frascati Manual (R & D statistics), the Canberra Manual (statistics on human resources in science and technology), OECD Patent Statistics Manual (patent statistics), Oslo Manual (innovation statistics) or other harmonised standards.
   Article 5
   Member States shall provide the variables listed in Annexes I and II, including confidential data, to the Commission (Eurostat), using the technical standard determined by the Commission (Eurostat) in cooperation with the Member States.
   Member States may provide the Commission (Eurostat) with individual data records on innovation statistics on a voluntary basis using the technical standard determined by the Commission (Eurostat).
   Article 6
   1.   Member States shall take all necessary measures to ensure the quality of the data provided.
   2.   Member States shall provide the Commission (Eurostat) with standard quality reports concerning the data on:

               (a)

               research and development (R & D);

               (b)

               government budget appropriations or outlays on research and development (GBAORD);

               (c)

               innovation.

         As far as research and development statistics are concerned, separate quality reports shall be drawn up for the business enterprise sector, government sector and higher education sector. Quality reports for the private non-profit sector shall be drawn up only if its R & D expenditure as a share of the total national R & D expenditure is more than 5 %.
   3.   Quality reports shall be drawn up by the Member States in accordance with the rules laid down in Annex III and shall cover the quality criteria defined in Article 12(1) of Regulation (EC) No 223/2009.
   4.   The first quality reports on R & D and GBAORD shall be drawn up for the data concerning the reference year 2011 and shall be submitted by 31 October 2013. For innovation statistics, the first quality reports shall be drawn up for the data concerning the reference year 2012 and shall be submitted by 31 October 2014. Subsequent quality reports shall be provided to the Commission (Eurostat) every second year within 22 months after the end of the reference year for which the data were collected.
   Article 7
   Regulations (EC) No 753/2004 and (EC) No 1450/2004 are repealed.
   However, Regulation (EC) No 753/2004 shall continue to apply as regards R & D and GBAORD statistics for the reference year 2011.
   References to the repealed Regulations shall be construed as references to this Regulation.
   Article 8
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 26 October 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 16.9.2003, p. 1.

      (2)  OJ L 87, 31.3.2009, p. 164.

      (3)  OJ L 118, 23.4.2004, p. 23.

      (4)  OJ L 267, 14.8.2004, p. 32.

      ANNEX I

         STATISTICS ON SCIENCE AND TECHNOLOGY

         Section 1

         Statistics on Research and Development

      1.   The statistics are to be compiled for R & D activity performed in the whole economy. The results shall relate to the population of all R & D performing units classified in Sections A to U of the common statistical classification of economic activities as established by Regulation (EC) No 1893/2006 of the European Parliament and of the Council (1) (NACE Rev.2).
      2.   The statistical units to be used in order to compile the statistics listed in paragraph 3 are: (a) enterprises for the statistics to be compiled at national level and (b) local units for the statistics to be compiled at regional level (NUTS 2). The definitions of the statistical units to be used (‘enterprise’ and ‘local unit’) are as set out in Council Regulation (EEC) No 696/93 of 15 March 1993 on the statistical units for the observation and analysis of the production system in the Community (2).
      3.   The list of statistics (including their breakdowns) to be compiled is set out below.

                  Code

                  Title

                  All sectors

                  By sector of performance

                  Business enterprise sector

                  Higher education sector

                  Government sector

                  Private non-profit sector

                  Comments

                  1.11

                     Number of R & D personnel in head count (HC)

                  Without breakdown

                  1.11.0.0

                  1.11.0.1

                  1.11.0.2

                  1.11.0.3

                  1.11.0.4

                  By occupation and sex

                  1.11.1.0

                  1.11.1.1

                  1.11.1.2

                  1.11.1.3

                  1.11.1.4

                  By qualification and sex

                  1.11.2.0

                  1.11.2.1

                  1.11.2.2

                  1.11.2.3

                  1.11.2.4

                  Optional

                  By principal economic activity (NACE)

                  1.11.3.1

                  By major field of science and sex

                  1.11.4.2

                  1.11.4.3

                  By region (NUTS 2)

                  1.11.5.0

                  1.11.5.1

                  1.11.5.2

                  1.11.5.3

                  1.11.5.4

                  By region (NUTS 2) and sex

                  1.11.6.0

                  1.11.6.1

                  1.11.6.2

                  1.11.6.3

                  1.11.6.4

                  Optional

                  By principal economic activity (NACE) and sex

                  1.11.7.1

                  1.12

                     Number of researchers in head Count (HC)

                  Without breakdown

                  1.12.0.0

                  1.12.0.1

                  1.12.0.2

                  1.12.0.3

                  1.12.0.4

                  By sex

                  1.12.1.0

                  1.12.1.1

                  1.12.1.2

                  1.12.1.3

                  1.12.1.4

                  By qualification and sex

                  1.12.2.0

                  1.12.2.1

                  1.12.2.2

                  1.12.2.3

                  1.12.2.4

                  Optional

                  By principal economic activity (NACE) and sex

                  1.12.3.1

                  By major field of science and sex

                  1.12.4.2

                  1.12.4.3

                  By region (NUTS 2)

                  1.12.5.0

                  1.12.5.1

                  1.12.5.2

                  1.12.5.3

                  1.12.5.4

                  By region (NUTS 2) and sex

                  1.12.6.0

                  1.12.6.1

                  1.12.6.2

                  1.12.6.3

                  1.12.6.4

                  Optional

                  By age group and sex

                  1.12.7.0

                  1.12.7.1

                  1.12.7.2

                  1.12.7.3

                  1.12.7.4

                  Optional

                  By citizenship and sex

                  1.12.8.0

                  1.12.8.1

                  1.12.8.2

                  1.12.8.3

                  1.12.8.4

                  Optional

                  1.13

                     Number of R & D personnel in full-time equivalent (FTE)

                  Without breakdown

                  1.13.0.0

                  1.13.0.1

                  1.13.0.2

                  1.13.0.3

                  1.13.0.4

                  Yearly

                  By occupation

                  1.13.1.0

                  1.13.1.1

                  1.13.1.2

                  1.13.1.3

                  1.13.1.4

                  By qualification

                  1.13.2.0

                  1.13.2.1

                  1.13.2.2

                  1.13.2.3

                  1.13.2.4

                  Optional

                  By principal economic activity (NACE)

                  1.13.3.1

                  By major field of science and sex

                  1.13.4.2

                  1.13.4.3

                  Optional

                  By region (NUTS 2)

                  1.13.5.0

                  1.13.5.1

                  1.13.5.2

                  1.13.5.3

                  1.13.5.4

                  By size class

                  1.13.6.1

                  Optional for the size classes 0 and one to nine employees

                  1.14

                     Number of researchers in full-time equivalent (FTE)

                  Without breakdown

                  1.14.0.0

                  1.14.0.1

                  1.14.0.2

                  1.14.0.3

                  1.14.0.4

                  Yearly

                  By sex

                  1.14.1.0

                  1.14.1.1

                  1.14.1.2

                  1.14.1.3

                  1.14.1.4

                  Optional

                  By qualification

                  1.14.2.0

                  1.14.2.1

                  1.14.2.2

                  1.14.2.3

                  1.14.2.4

                  Optional

                  By principal economic activity (NACE)

                  1.14.3.1

                  By major field of science and sex

                  1.14.4.2

                  1.14.4.3

                  Optional

                  By region (NUTS 2)

                  1.14.5.0

                  1.14.5.1

                  1.14.5.2

                  1.14.5.3

                  1.14.5.4

                  By region (NUTS 2) and sex

                  1.14.6.0

                  1.14.6.1

                  1.14.6.2

                  1.14.6.3

                  1.14.6.4

                  Optional

                  By size class

                  1.14.7.1

                  Optional for the size classes 0 and one to nine employees

                  1.20

                     Intramural R & D expenditure

                  Without breakdown

                  1.20.0.0

                  1.20.0.1

                  1.20.0.2

                  1.20.0.3

                  1.20.0.4

                  Yearly

                  By source of funds

                  1.20.1.0

                  1.20.1.1

                  1.20.1.2

                  1.20.1.3

                  1.20.1.4

                  By type of R & D

                  1.20.3.0

                  1.20.3.1

                  1.20.3.2

                  1.20.3.3

                  1.20.3.4

                  Optional for HES and for all sectors

                  By type of costs

                  1.20.4.0

                  1.20.4.1

                  1.20.4.2

                  1.20.4.3

                  1.20.4.4

                  By principal economic activity (NACE)

                  1.20.5.1.1

                  By product field (NACE)

                  1.20.5.1.2

                  Optional

                  By size class

                  1.20.6.1

                  Optional for the size classes 0 and one to nine employees

                  By source of funds and size class

                  1.20.7.1

                  Optional for the size classes 0 and one to nine employees

                  By major field of science

                  1.20.8.2

                  1.20.8.3

                  By socioeconomic objective (SEO)

                  1.20.9.3

                  Optional

                  By region (NUTS 2)

                  1.20.10.0

                  1.20.10.1

                  1.20.10.2

                  1.20.10.3

                  1.20.10.4

            4.   All variables shall be provided every two years in each odd year, except those where the tables in paragraph 3 stipulate that they shall be provided annually.
      5.   The first reference year for which the statistics listed in paragraph 3 are to be compiled is the calendar year 2012.
      6.   The results are to be provided within 18 months of the end of the calendar year of the reference period. In addition, preliminary results for the variables with an annual frequency are to be provided within 10 months of the end of the calendar year of the reference period.
      7.   Production of results

                  7.1.

                  The results of the statistics by occupation are to be broken down into ‘researchers’ and ‘other R & D personnel’.

                  7.2.

                  The results of the statistics by qualification are to be broken down into ‘PhD holders (ISCED 2011 level 8)’, ‘other university degrees and other tertiary diplomas (ISCED 2011 levels 5, 6 and 7)’ and ‘other qualifications’.

                  7.3.

                  The results of the statistics by major field of science are to be broken down into ‘natural sciences’, ‘engineering and technology’, ‘medical sciences’, ‘agricultural sciences’, ‘social sciences’ and ‘humanities’.

                  7.4.

                  The results of the statistics by size class are to be broken down into the following size classes: ‘0 employees’, ‘one to nine employees’, ‘10 to 49 employees’, ‘50 to 249 employees’, ‘250 to 499 employees’, ‘500 and more employees’.

                  7.5.

                  The results of the statistics by source of funds are to be broken down into the ‘business enterprise sector’, ‘government sector’, ‘private non-profit sector’, ‘higher education sector’ and ‘abroad’. The category ‘abroad’ is to be further broken down into: ‘foreign business enterprises’, ‘European Commission’, ‘international organisations’ and ‘other sources’. For the business enterprise sector category ‘foreign business enterprises’ is to be further broken down into ‘foreign enterprises within the same group’ and ‘other foreign enterprises’.

                  7.6.

                  The results of the statistics by type of R & D are to be broken down into ‘basic research’, ‘applied research’ and ‘experimental development’.

                  7.7.

                  The results of the statistics by type of costs are to be broken down into ‘current costs (labour costs and other costs)’ and ‘capital expenditure’.

                  7.8.

                  The results of the statistics by socioeconomic objective (SEO) are to be broken down in accordance with the nomenclature for the analysis and comparison of scientific programmes and budgets (NABS) at chapter level.

                  7.9.

                  The results of the statistics by age group are to be broken down into the following age classes (in years): ‘up to 25’, ‘25 to 34’, ‘35 to 44’, ‘45 to 54’, ‘55 to 64’, ‘65 and more’.

                  7.10.

                  The results of the statistics by citizenship are to be broken down into the following categories: ‘national citizenship’, ‘citizenship of other EU Member States’, ‘citizenship of other European countries’, ‘citizenship of North America’, ‘citizenship of Central and South America’; ‘citizenship of Asia’, ‘citizenship of Africa’, ‘other citizenship’.

                  7.11.

                  The results of the statistics by principal economic activity and by product field (NACE Rev. 2) are to be broken down into the following NACE Rev. 2 divisions, groups and aggregates:
                  ‘01, 02, 03’, ‘05, 06, 07, 08, 09’, ‘10 to 33’, ‘10, 11, 12’, ‘10, 11’, ‘12’, ‘13, 14, 15’, ‘13’, ‘14’, ‘15’, ‘16, 17, 18’, ‘16’, ‘17’, ‘18’, ‘19’, ‘20’, ‘21’, ‘22’, ‘23’, ‘24’, ‘25, 26, 27, 28, 29, 30’, ‘25’, ‘25.4’, ‘26’, ‘26.1’, ‘26.2’, ‘26.3’, ‘26.4’, ‘26.5’, ‘26.6’, ‘26.7’, ‘27’, ‘28’, ‘29’, ‘30’, ‘30.1’, ‘30.2’, ‘30.3’, ‘30.4’, ‘31’, ‘32’, ‘32.5’, ‘33’, ‘35, 36, 37, 38, 39’‘35, 36’, ‘37, 38, 39’, ‘41, 42, 43’, ‘45, 46, 47, 49, 50, 51, 52, 53, 55, 56, 58, 59, 60, 61, 62, 63, 64, 65, 66, 68, 69, 70, 71, 72, 73, 74, 75, 77, 78, 79, 80, 81, 82’, ‘45, 46, 47’, ‘49, 50, 51, 52, 53’, ‘55, 56’, ‘58, 59, 60, 61, 62, 63’, ‘61’, ‘62’, ‘63’, ‘64, 65, 66’, ‘68’, ‘69, 70, 71, 72, 73, 74, 75’, ‘71’, ‘72’, ‘72.1’, ‘72.2’, ‘77, 78, 79, 80, 81, 82’, ‘84, 85’, ‘86, 87, 88’, ‘86’, ‘87, 88’, ‘90, 91, 92, 93’, ‘94, 95, 96, 97, 98, 99’, ‘01 to 99’.

            8.   The concepts and definitions related to the statistics defined in this section are laid down in the Frascati Manual.
      9.   On a voluntary basis, pilot studies will be undertaken by the Commission and/or Member States on additional variables and breakdowns of R & D statistics with a view to strengthening the scientific evidence base of R & D policy-making. The pilot studies are to be carried out in order to assess the relevance and feasibility of obtaining data, taking into account the benefits of the availability of the data in relation to the cost of collection and the burden on business. Topics of the pilot studies will be decided in close cooperation with the Member States.

         Section 2

         Statistics on government budget appropriations or outlays on research and development (GBAORD)

      1.   The following statistics are to be compiled:

                  Code

                  Title

                  21.0

                  Government R & D appropriations in the provisional budget (as approved by the Parliament at the beginning of the budget year)

                  21.1

                  Government R & D appropriations in the final budget (revised budget approved during the budget year)

                  22.0

                  National public funding to transnationally coordinated R & D

            2.   All variables shall be provided annually.
      3.   The first reference year for which the statistics are to be compiled is the calendar year 2012.
      4.   The results are to be provided within six months of the end of the calendar year of the reference period for variable 21.0 (including all breakdowns) and within 12 months for variables 21.1 and 22.0 (including all breakdowns).
      5.   Production of results

                  5.1.

                  The results of the statistics compiled for the variables 21.0 and 21.1 are to be broken down in accordance with the nomenclature for the analysis and comparison of scientific programmes and budgets (NABS 2007) at chapter level.

                  5.2.

                  The results of the statistics compiled for the variable 21.1 are to be broken down:

                              (a)

                              in accordance with the nomenclature for the analysis and comparison of scientific programmes and budgets (NABS 2007) at subchapter level — optional;

                              (b)

                              into ‘project funding’ and ‘institutional funding’ — optional.

                  5.3.

                  The results of the statistics compiled for the variable 22.0 are to be broken down into ‘national contributions to transnational public R & D performers’, ‘national contributions to Europe-wide transnational public R & D programmes’ and ‘national contributions to bilateral or multilateral public R & D programmes established between Member State governments (and with candidate countries and EFTA countries)’.

            6.   The concepts and definitions related to the statistics defined in this section are laid down in the Frascati Manual or other harmonised standards.

         Section 3

         Other statistics on science and technology

      The work relating to the other areas of statistics on science and technology shall refer in particular to the following domains:

                  (a)

                  statistics on human resources in science and technology (including gender and mobility statistics) (HRST): development and implementation of a comprehensive framework for statistics on HRST principally by exploiting existing national and international data sources more effectively (also within the European statistical system). Particular attention is to be paid to gender aspects;

                  (b)

                  statistics on patents: development and implementation of a comprehensive framework for statistics on patents by regularly producing international and national patent statistics and indicators based on the information available at national and international patent offices;

                  (c)

                  statistics on high-technology industries and knowledge-based services: development and implementation of a comprehensive framework for statistics on high-technology industries and knowledge-based services, principally by exploiting existing national and international data sources more effectively (also within the European statistical system). This work also comprises the identification and classification of activities and products, the measurement of economic performance of these activities and their contribution to performance of the economy as a whole;

                  (d)

                  other statistics on science and technology: the additional development and implementation work is related, inter alia, to statistics on biotechnology, nanotechnology or other areas where science and technology is vital for meeting European Union priorities (like health, security, environment and climate change).

            For the domains listed in this section, the necessary data will mostly be acquired through existing statistical or other data sources (e.g. in the area of social or economic statistics).

         (1)  OJ L 393, 30.12.2006, p. 1.

         (2)  OJ L 76, 30.3.1993, p. 1.

      ANNEX II

         INNOVATION STATISTICS

         Section 1

      The enterprise is the statistical unit to be used for the compilation of the statistics listed in Section 2. The definitions of the statistical units to be used (‘enterprise’) are as set out in Regulation (EEC) No 696/93.

         Section 2

      Member States shall compile the following innovation statistics:

                  Variable

                  Title

                  Comments

                  1

                  Number of innovation active enterprises

                  As absolute value and as a percentage of all enterprises

                  2

                  Number of innovating enterprises that introduced new or significantly improved products, new to the market/new to enterprise

                  As absolute value, as a percentage of all enterprises and as a percentage of all innovation active enterprises

                  3

                  Turnover from innovation, related to new or significantly improved products, new to the market

                  As absolute value, as a percentage of total turnover and as a percentage of total turnover from innovation active enterprises

                  4

                  Turnover from innovation, related to new or significantly improved products, new to the firm, but not new to the market

                  As absolute value, as a percentage of total turnover and as a percentage of total turnover from innovation active enterprises

                  5

                  Number of innovation active enterprises involved in innovation cooperation

                  As absolute value and as a percentage of innovation active enterprises

                  6

                  Innovation expenditure

                  As absolute value, as a percentage of total turnover and as a percentage of total turnover from innovation active enterprises

                  7

                  Number of innovation active enterprises that indicated highly important objectives of innovation

                  As absolute value and as a percentage of all innovation active enterprises — optional

                  8

                  Number of innovation active enterprises that indicated highly important sources of information for innovation

                  As absolute value and as a percentage of all innovation active enterprises — optional

                  9

                  Number of enterprises facing important hampering factors

                  As absolute value, as a percentage of all enterprises, as a percentage of all innovation active enterprises and as a percentage of non-innovation active enterprises — optional

                  10

                  Number of innovating enterprises that developed the innovations itself or together with the other enterprises/institutions

                  As absolute value and as a percentage of all innovation active enterprises

            Beyond the statistics listed above, Members States may compile additional statistics (including their breakdowns) in accordance with the main themes listed in the Oslo Manual. Inclusion of these additional statistics will be decided in close cooperation with Member States and incorporated in the harmonised survey questionnaire.

         Section 3

      Market activity enterprises in the NACE Rev. 2 sections B, C, D, E, H, J, K and in the NACE Rev. 2 divisions 46 and divisions 71, 72 and 73 are to be covered. Member States have the option of further extending the coverage.

         Section 4

      All variables shall be provided every two years in each even year.

         Section 5

      The first reference year for which the statistics are to be compiled is the calendar year 2012.

         Section 6

                  1.

                  All results are to be broken down by economic activity by NACE Rev. 2 sections, divisions or other aggregates and by the employment size classes as follows:

                              NACE category/ size category

                              10-49 employees

                              50-249 employees

                              above 249 employees

                              total

                              ‘B-C-D-E-46-H-J-K-71-72-73’

                              x

                              x

                              x

                              x

                              ‘B-C-D-E’

                              x

                              x

                              x

                              x

                              ‘B’

                              x

                              x

                              x

                              x

                              ‘C’

                              x

                              x

                              x

                              x

                              ‘10 to 12’

                              x

                              ‘13 to 15’

                              x

                              ‘16 to 18’

                              x

                              ‘19 to 22’

                              x

                              ‘20’

                              x

                              ‘21’

                              x

                              ‘23’

                              x

                              ‘24’

                              x

                              ‘25 to 30’

                              x

                              ‘25’

                              x

                              ‘26’

                              x

                              ‘31 to 33’

                              x

                              ‘D’

                              x

                              x

                              x

                              x

                              ‘E’

                              x

                              x

                              x

                              x

                              ‘36’

                              x

                              ‘37 to 39’

                              x

                              ‘46-H-J-K-71-72-73’

                              x

                              x

                              x

                              x

                              ‘46’

                              x

                              x

                              x

                              x

                              ‘H’

                              x

                              x

                              x

                              x

                              ‘49 to 51’

                              x

                              ‘52 to 53’

                              x

                              ‘J’

                              x

                              x

                              x

                              x

                              ‘58’

                              x

                              ‘61’

                              x

                              ‘62’

                              x

                              ‘63’

                              x

                              ‘K’

                              x

                              x

                              x

                              x

                              ‘64’

                              x

                              ‘65’

                              x

                              ‘66’

                              x

                              ‘71-72-73’

                              x

                              x

                              x

                              x

                              ‘71’

                              x

                              ‘72’

                              x

                              ‘73’

                              x

                  2.

                  The results of variable 1 shall cover and be broken down into four types of innovations: process, product, organisational and marketing innovations. The results of variables 5 to 10 shall cover enterprises with process and/or product innovation activities. Coverage and breakdown by four types of innovations for the variables other than 1 will be decided in close cooperation with Member States and incorporated in the harmonised survey questionnaire.

                  3.

                  The results of variable 5 are to be broken down by type of innovation cooperation. The results of variable 6 are to be broken down by type of innovation expenditures. The results of variable 7 are to be broken down by type of objectives of innovation. The results of variable 8 are to be broken down by type of sources of information. The results of variable 9 are to be broken down by type of hampering factors. The results of variable 10 are to be broken down by type of developers. These breakdowns will be decided in close cooperation with Member States and incorporated in the harmonised survey questionnaire.

         Section 7

                  1.

                  All results are to be provided within 18 months of the end of the calendar year of the reference period.

                  2.

                  Member States may, on a voluntary basis, provide the Commission (Eurostat) with individual data records covering all statistical units surveyed as part of the national innovation surveys.

         Section 8

                  1.

                  The survey questionnaire, which is used for the innovation surveys carried out every two years and starting with the reference year 2012, shall cover the main themes listed in the Oslo Manual with regard to the measurement of innovation in enterprises.

                  2.

                  In close cooperation with the Member States, methodological recommendations for the innovation surveys shall be drawn up by the Commission (Eurostat) leading to a high level of harmonisation of the survey results. These recommendations shall cover at least the target population, the survey methodology (including regional aspects), the harmonised survey questionnaire, the collection, processing and provision of the data, and data quality requirements.

                  3.

                  Member States shall provide the Commission (Eurostat) with the necessary information concerning the national methodology used in national innovation statistics.

      ANNEX III

         REQUIREMENTS FOR QUALITY REPORTS

         Section 1

         Introduction

      The quality reports shall contain both quantitative and qualitative indicators of the quality of the data, in the standard structure determined by the Commission in cooperation with the Member States. The Commission (Eurostat) shall provide the results for those quantitative indicators which can be calculated on the basis of data provided by Member States. Member States shall interpret and comment on them, in the light of their collection methodology and provide the remaining quantitative indicators as well as qualitative information.

         Section 2

         Timeline

      Every second year, the Commission (Eurostat) shall, within 20 months after the end of the reference year (by the end of August), supply the Member States with draft standard quality reports, pre-filled with quality indicators and other information available to the Commission (Eurostat).
      Every second year, Member States shall supply the Commission (Eurostat) within 22 months after the end of the reference year (by the end of October) with the completed standard quality reports.


title: Commission Implementing Regulation (EU) 2017/65 of 14 December 2016 concerning the authorisation of 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene as feed additives for all animal species (Text with EEA relevance. )

text:
                  17.1.2017

                  EN

                  Official Journal of the European Union

                  L 13/246

            COMMISSION IMPLEMENTING REGULATION (EU) 2017/65
      of 14 December 2016
      concerning the authorisation of 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene as feed additives for all animal species
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

                  Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                  (2)

                  1-Isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene, were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                  (3)

                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinions (3) of 10 March 2015 and of 1 December 2015 that, under the proposed conditions of use in feed 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene in feed is similar to that on food. The Authority has already concluded that for food 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene are efficacious, as it increases the food smell or palatability. The Authority could not conclude on the safety of for pin-2(3)-ene, pin-2(10)-ene, delta-3-carene, beta-caryophyllene and camphene used in water for drinking. The Authority concluded that for d-limonene, 1-isopropyl-4-methylbenzene and 1-isopropenyl-4-methylbenzene the absence of margin of safety would not allow simultaneous administration in feed and water. However, those substances can be used within a compound feed subsequently administered via water.

                  (5)

                  Restrictions and conditions should be provided for to allow better control. For practical reasons and taking into account the re-evaluation performed by the Authority, maximum recommended contents should be set up. Where the recommended content of the additive in complete feedingstuff is exceeded, the identification number of the feed additive, its name and added amount should be indicated on the label of premixtures, compound feeds and feed materials.

                  (6)

                  The Authority concluded that in the absence of data on user safety 1-Isopropyl- 4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene should be considered as irritant to skin, eyes and respiratory tract and as a skin sensitiser. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (7)

                  The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

                  (8)

                  Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for 1-isopropyl- 4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

                  (9)

                  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

            HAS ADOPTED THIS REGULATION:
      Article 1
      Authorisation
      The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
      Article 2
      Transitional measures
      1.   The substances as specified in the Annex and premixtures containing those substances, which are produced and labelled before 6 August 2017 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
      2.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2018 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
      3.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2019 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
      Article 3
      Entry into force
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 14 December 2016.

               For the Commission

               The President

            Jean-Claude JUNCKER

         (1)  OJ L 268, 18.10.2003, p. 29.

         (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

         (3)  EFSA Journal 2015;13(3):4053 and EFSA Journal 2016;14(1):4339

         ANNEX

                     Identification number of the additive

                     Name of the holder of authorisation

                     Additive

                     Composition, chemical formula, description, analytical method

                     Species or category of animal

                     Maximum age

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

                     mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                     (1)

                     (2)

                     (3)

                     (4)

                     (5)

                     (6)

                     (7)

                     (8)

                     (9)

                        Category: Sensory additives. Functional group: Flavouring compounds

                     2b01002

                     —

                     1-Isopropyl-4-methylbenzene

                        Additive composition

                        1-Isopropyl-4-methylbenzene

                        Characterisation of the active substance

                     1-Isopropyl-4-methylbenzene
                     Produced by chemical synthesis
                     Purity: min 97 %
                     C10H14

                     CAS No 99¬87-6
                     FLAVIS No: 01.002

                        Method of analysis
                         (1)

                     For the determination of 1-isopropyl-4-methylbenzene in the feed additive and in feed flavouring premixtures:
                     Gas-chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be:
                                 For cats: 14 mg/kg, and for other species and categories: 25 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

                                             —

                                             14 mg/kg for cats;

                                             —

                                             25 mg/kg for other species and categories.’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

                                             —

                                             14 mg/kg for cats;

                                             —

                                             25 mg/kg for other species and categories.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     6 February 2027

                     2b01003

                     —

                     Pin-2(10)-ene

                        Additive composition

                     Pin-2(10)-ene

                        Characterisation of the active substance

                     Pin-2(10)-ene
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C10H16

                     CAS No 127-91-3
                     FLAVIS No: 01.003

                        Method of analysis
                         (1)

                     For the determination of pin-2(10)-ene in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     6 February 2027

                     2b01004

                     —

                     Pin-2(3)-ene

                        Additive composition

                     Pin-2(3)-ene

                        Characterisation of the active substance

                     Pin-2(3)-ene
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C10H16

                     CAS No 80-56-8
                     FLAVIS No: 01.004

                        Method of analysis
                         (1)

                     For the determination of pin-2(3)-ene in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     6 February 2027

                     2b01007

                     —

                     beta-caryophyllene

                        Additive composition

                     beta-caryophyllene

                        Characterisation of the active substance

                     beta-caryophyllene
                     Produced by chemical synthesis
                     Purity: min. 80 %
                     Chemical formula: C15H24

                     CAS No 87-44-5
                     FLAVIS No: 01.007

                        Method of analysis
                         (1)

                     For the determination of beta-caryophyllene in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     6 February 2027

                     2b01009

                     —

                     Camphene

                        Additive composition

                     Camphene

                        Characterisation of the active substance

                     Camphene
                     Produced by chemical synthesis
                     Purity: min. 80 %
                     Chemical formula: C10H16

                     CAS No 79-92-5
                     FLAVIS No: 01.009

                        Method of analysis
                         (1)

                     For the determination of camphene in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     6 February 2027

                     2b01010

                     —

                     1-Isopropenyl-4-methylbenzene

                        Additive composition

                     1-Isopropenyl-4-methylbenzene

                        Characterisation of the active substance

                     1-Isopropenyl-4-methylbenzene
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C10H12

                     CAS No 1195-32-0
                     FLAVIS No:01.010

                        Method of analysis
                         (1)

                     For the determination of 1-Isopropenyl-4-methylbenzene in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be:
                                 for pigs and poultry: 1 mg/kg, and for other species and categories: 1,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

                                             —

                                             1 mg/kg for pigs and poultry;

                                             —

                                             1,5 mg/kg for other species and categories.’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

                                             —

                                             1 mg/kg for pigs and poultry;

                                             —

                                             1,5 mg/kg for other species and categories.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     6 February 2027

                     2b01029

                     —

                     delta-3-Carene

                        Additive composition

                     delta-3-Carene

                        Characterisation of the active substance

                     delta-3-Carene
                     Produced by chemical synthesis
                     Purity: min. 92 %
                     Chemical formula: C10H16

                     CAS No 13466-78-9
                     FLAVIS No:01.029

                        Method of analysis
                         (1)

                     For the determination of delta-3-Carene in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     6 February 2027

                     2b01045

                     —

                     d-Limonene

                        Additive composition

                     d-Limonene

                        Characterisation of the active substance

                     d-Limonene
                     Produced by chemical synthesis
                     Purity: min. 96 %
                     Chemical formula: C10H16

                     CAS No 5989-27-5
                     FLAVIS No: 01.045

                        Method of analysis
                         (1)

                     For the determination of d-limonene in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species except male rats

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be 25 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     6 February 2027

            (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2016/177 of 10 February 2016 approving the active substance benzovindiflupyr, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

text:
               11.2.2016

               EN

               Official Journal of the European Union

               L 35/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/177
   of 10 February 2016
   approving the active substance benzovindiflupyr, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 24 in conjunction with Article 13(2) thereof,
   Whereas:

               (1)

               In accordance with Article 7(1) of Regulation (EC) No 1107/2009, France received on 20 December 2012 an application from Syngenta Crop Protection AG for the approval of the active substance benzovindiflupyr.

               (2)

               In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) of the admissibility of the application on 15 February 2013.

               (3)

               On 25 March 2014 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

               (4)

               The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in February 2015.

               (5)

               On 10 March 2015 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance benzovindiflupyr can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public.

               (6)

               On 13 July 2015 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for benzovindiflupyr and a draft Regulation providing that benzovindiflupyr is approved.

               (7)

               The applicant was given the possibility to submit comments on the review report.

               (8)

               It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the Commission review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied.

               (9)

               The Commission however considers that benzovindiflupyr is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Benzovindiflupyr is a persistent and toxic substance in accordance with points 3.7.2.1 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in soil and fresh water sediment is higher than 120 days and the long-term no-observed effect concentration for freshwater organisms is less than 0,01 mg/L. Benzovindiflupyr therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

               (10)

               It is therefore appropriate to approve benzovindiflupyr as a candidate for substitution.

               (11)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

               (12)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

               (13)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of the active substance as a candidate for substitution
   The active substance benzovindiflupyr is approved as set out in Annex I as a candidate for substitution.
   Article 2
   Amendment to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 3
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 10 February 2016.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  EFSA Journal 2015;13(3):4043. Available online: www.efsa.europa.eu

      (3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Benzovindiflupyr
                  CAS No: 1072957-71-1
                  CIPAC No: not available

                     N-[(1RS,4SR)-9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide

                  960 g/kg (50/50) racemate

                  2.3.2016

                  2.3.2023

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benzovindiflupyr, and in particular Appendices I and II thereof, shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms.
                  Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards:

                              (1)

                              the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;

                              (2)

                              the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;

                              (3)

                              the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water.

                        The applicant shall submit to the Commission, the Member States and the Authority the information requested under points (1) and (2) by 2 September 2016 and the information requested under point (3) within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

         (1)  Further details on identity and specification of active substance are provided in the review report.

      ANNEX II
      In Part E of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘4

                     Benzovindiflupyr
                     CAS No: 1072957-71-1
                     CIPAC No: not available

                        N-[(1RS,4SR)-9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide

                     960 g/kg (50/50) racemate

                     2.3.2016

                     2.3.2023

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benzovindiflupyr, and in particular Appendices I and II thereof, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms.
                     Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards:

                                 (1)

                                 the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;

                                 (2)

                                 the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;

                                 (3)

                                 the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water.

                           The applicant shall submit to the Commission, the Member States and the Authority the information requested under points (1) and (2) by 2 September 2016 and the information requested under point (3) within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Implementing Regulation (EU) 2016/931 of 1 June 2016 entering a name in the register of protected designations of origin and protected geographical indications (Sel de Salies-de-Béarn (PGI))

text:
               14.6.2016

               EN

               Official Journal of the European Union

               L 155/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/931
   of 1 June 2016
   entering a name in the register of protected designations of origin and protected geographical indications (Sel de Salies-de-Béarn (PGI))
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
   Whereas:

               (1)

               Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, France's application to register the name ‘Sel de Salies-de-Béarn’ was published in the Official Journal of the European Union
                   (2).

               (2)

               As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Sel de Salies-de-Béarn’ should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Sel de Salies-de-Béarn’ (PGI) is hereby entered in the register.
   The name specified in the first paragraph denotes a product in Class 2.6. Salt, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 1 June 2016.

            For the Commission,

            On behalf of the President,

         Phil HOGAN

            Member of the Commission

      (1)  OJ L 343, 14.12.2012, p. 1.

      (2)  OJ C 53, 12.2.2016, p. 14.

      (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) No 1410/2013 of 23 December 2013 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               24.12.2013

               EN

               Official Journal of the European Union

               L 352/45

         COMMISSION IMPLEMENTING REGULATION (EU) No 1410/2013
   of 23 December 2013
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

               Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

               (2)

               The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 23 December 2013.

            For the Commission, On behalf of the President,
         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX
      Standard import values for determining the entry price of certain fruit and vegetables

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  IL

                  153,9

                  MA

                  71,1

                  TN

                  110,9

                  TR

                  117,6

                  ZZ

                  113,4

                  0707 00 05

                  AL

                  99,8

                  JO

                  158,2

                  MA

                  158,2

                  TR

                  148,8

                  ZZ

                  141,3

                  0709 93 10

                  MA

                  80,0

                  TR

                  168,2

                  ZZ

                  124,1

                  0805 10 20

                  MA

                  61,8

                  TR

                  45,3

                  ZA

                  51,6

                  ZZ

                  52,9

                  0805 20 10

                  MA

                  70,5

                  ZZ

                  70,5

                  0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

                  CN

                  35,9

                  IL

                  102,5

                  JM

                  133,9

                  MA

                  69,9

                  TR

                  73,4

                  ZZ

                  83,1

                  0805 50 10

                  AR

                  102,8

                  TR

                  63,2

                  ZZ

                  83,0

                  0808 10 80

                  CN

                  81,7

                  MK

                  33,9

                  US

                  92,0

                  ZZ

                  69,2

                  0808 30 90

                  TR

                  124,7

                  US

                  150,9

                  ZZ

                  137,8

         (1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.


title: Commission Implementing Regulation (EU) 2015/393 of 9 March 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               10.3.2015

               EN

               Official Journal of the European Union

               L 65/20

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/393
   of 9 March 2015
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

               Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

               (2)

               The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 9 March 2015.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

      (1)  OJ L 347, 20.12.2013, p. 671.

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX

         Standard import values for determining the entry price of certain fruit and vegetables

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  EG

                  65,6

                  MA

                  82,2

                  TR

                  83,0

                  ZZ

                  76,9

                  0707 00 05

                  JO

                  229,9

                  MA

                  206,0

                  TR

                  189,5

                  ZZ

                  208,5

                  0709 93 10

                  MA

                  111,2

                  TR

                  190,3

                  ZZ

                  150,8

                  0805 10 20

                  EG

                  49,0

                  IL

                  73,9

                  MA

                  61,6

                  TN

                  54,4

                  TR

                  70,8

                  ZZ

                  61,9

                  0805 50 10

                  TR

                  53,2

                  ZZ

                  53,2

                  0808 10 80

                  BR

                  68,8

                  CA

                  85,3

                  CL

                  94,4

                  MK

                  24,7

                  US

                  211,2

                  ZZ

                  96,9

                  0808 30 90

                  AR

                  116,8

                  CL

                  128,1

                  CN

                  90,9

                  ZA

                  101,0

                  ZZ

                  109,2

         (1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.