title: Commission Directive 2005/63/EC of 3 October 2005 correcting Directive 2005/26/EC concerning the list of food ingredients or substances provisionally excluded from Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council   (Text with EEA relevance)

text:
               4.10.2005

               EN

               Official Journal of the European Union

               L 258/3

      COMMISSION DIRECTIVE 2005/63/EC
   of 3 October 2005
   correcting Directive 2005/26/EC concerning the list of food ingredients or substances provisionally excluded from Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (1) and in particular Article 6 (11), thereof,
   Whereas:

               (1)

               Commission Directive 2005/26/EC (2) established the list of food ingredients or substances provisionally excluded from Annex IIIa of Directive 2000/13/EC, having heard the opinion of the European Food Safety Authority (EFSA).

               (2)

               In its opinion of 2 December 2004 on certain uses of fish gelatine, the EFSA concluded that this product, when used as a carrier for vitamin and carotenoid preparations, is not likely to cause severe allergic reactions.

               (3)

               Carotenoids were wrongly omitted from the list in annex to Directive 2005/26/EC and must therefore be added to it,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In the second column of the Annex to Directive 2005/26/EC, the seventh row shall be replaced by the following:

               ‘—

               Fish gelatine used as a carrier for vitamin or carotenoid preparations and flavours.’

         Article 2
   1.   The Member States shall adopt and publish, by 3 December 2005 at the latest, the rules, regulations and administrative provisions necessary to comply with the present Directive. They shall immediately communicate the text of those provisions to the Commission together with a correlation table those provisions and this Directive.
   They shall apply those provisions from 25 November 2005.
   When the Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by a reference at the time of their official publication. The Member States shall determine how such reference is to be made.
   2.   The Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 3 October 2005.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).

      (2)  OJ L 75, 22.3.2005, p. 33.


Avis juridique important

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31995L0032

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products

Official Journal L 178 , 28/07/1995 P. 0020 - 0035

SIXTH  COMMISSION DIRECTIVE 95/32/ECof 7 July 1995relating to methods of analysis necessary for checking  the composition of cosmetic products(Text with EEA relevance)THE COMMISSION OF  THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of  the Member States relating to cosmetic products (1), as last amended by Commission Directive  94/32/EC (2), and in particular Article 8 (1) thereof, Whereas Directive 76/768/EEC provides for the official testing of cosmetic products with the aim of  ensuring that the conditions laid down by Commission provisions concerning the composition of  cosmetic products are satisfied; Whereas all the necessary methods of analysis should be laid down as quickly as possible; whereas  certain methods have already been adopted in Commission Directives 80/1335/EEC (3), as amended by  Directive 87/143/EEC (4), 82/434/EEC (5), as amended by Directive 90/207/EEC (6), 83/514/EEC (7),  85/490/EEC (8) and 93/73/EEC (9); Whereas the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid,  salicylic acid and propionic acid in cosmetic products and the identification and determination of  hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone  monobenzylether in cosmetic products constitute a sixth step; Whereas the measures provided for in this Directive are in accordance with the opinion of the  Committee on the adaptation of Directive 76/768/EEC to technical progress, HAS ADOPTED THIS DIRECTIVE: Article 1Member States shall take all the necessary steps to ensure that  during official testing of cosmetic products: - identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic  acid and propionic acid, - identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone  monoethylether and hydroquinone monobenzylether, shall be carried out in accordance with the methods described in the Annex. Article 21. Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive no later than 30 September 1996. They shall  forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or  shall be accompanied by such reference at the time of their official publication. The procedure for  such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the provisions of national law which they  adopt in the field covered by this Directive. Article 3This Directive shall enter into force on the 20th day following its publication in the  Official Journal of the European Communities. Article 4This Directive is addressed to the Member States. Done at Brussels, 7 July 1995. For the CommissionEmma BONINOMember of the Commission(1) OJ No L 262, 27. 9.  1976, p. 169. (2) OJ No L 181, 15. 7. 1994, p. 31. (3) OJ No L 383, 31. 12. 1980, p. 27. (4) OJ No L 57, 27. 2. 1987, p. 56. (5) OJ No L 185, 30. 6. 1982, p. 1. (6) OJ No L 108, 28. 4. 1990, p. 92. (7) OJ No L 291, 24. 10. 1983, p. 9. (8) OJ No L 295, 7. 11. 1985, p. 30. (9) OJ No L 231, 14. 9. 1993, p. 34.  ANNEX I. IDENTIFICATION AND DETERMINATION OF BENZOIC ACID, 4-HYDROXYBENZOIC ACID, SORBIC  ACID, SALICYLIC ACID AND PROPIONIC ACID IN COSMETIC PRODUCTS1. Scope and field of applicationThe  method is applicable to the identification and determination of benzoic acid, 4-hydroxybenzoic  acid, sorbic acid, salicylic acid and propionic acid in cosmetic products. Separate procedures  describe the identification of these preservatives; the determination of propionic acid; and the  determination of 4-hydroxybenzoic acid, salicylic acid, sorbic acid and benzoic acid. 2. DefinitionThe amounts of benzoic acid, 4-hydroxybenzoic acid, salicylic acid, sorbic acid and  propionic acid determined by this method are expressed as percentage by mass of the free acids. A. IDENTIFICATION1. PrincipleFollowing acid/base extraction of the preservatives, the extract is  analysed by thin layer chromatography (TLC) employing on-date derivatization. Depending on the  results, the identification is confirmed by high performance liquid chromatography (HPLC) or, in  the case of propionic acid, by gas chromatography (GC). 2. Reagents2.1. GeneralAll reagents must be of analytical purity. Water used must be distilled  water, or water of at least equivalent purity2.2. Acetone2.3. Diethyl ether2.4.  Acetonitrile2.5. Toluene2.6. n-Hexane2.7. Paraffin, liquid2.8. Hydrochloric acid, 4 M2.9.  Potassium hydroxide, aqueous, 4 M2.10. Calcium chloride, CaCl2.2H2O2.11. Lithium carbonate,  Li2CO32.12. 2-Bromo-2′-acetonaphthone2.13. 4-Hydroxybenzoic acid2.14. Salicylic acid2.15.  Benzoic acid2.16. Sorbic acid2.17. Propionic acid2.18. Reference solutionsPrepare 0,1 % (m/v)  solutions (100 mg/100 ml) of each of the five preservatives (2.13 to 2.17) in diethyl ether2.19.  Derivatization reagent0,5 % (m/v) solution of 2-bromo-2′-acetonaphthone (2.12) in  acetonitrile (2.4) (50 mg/10 ml). This solution should be prepared weekly and stored in a  refrigerator2.20. Catalyst solution0,3 % (m/v) solution of lithium carbonate (2.11) in water (300  mg/100 ml). This solution should be freshly prepared2.21. Development solventToluene  (2.5)/Acetone (2.2) (20:0,5, v/v)2.22. Liquid paraffin (2.7)/n-hexane (2.6) (1:2, v/v)3.  ApparatusOrdinary laboratory equipment3.1. Water bath, capable of maintaining a temperature of 60  °C3.2. Developing tank3.3. Ultraviolet light source, 254 and 366 nm3.4. Thin layer plates,  Kieselgel 60, without fluorescence indicator, 20 × 20 cm, layer thickness 0,25 mm with  concentrating zone 2,5 × 20 cm (Merck 11845, or equivalent)3.5. Microsyringe, 10 µl3.6.  Microsyringe, 25 µl3.7. Oven, capable of maintaining temperatures up to 105 °C3.8. 50-ml glass  tubes with screw cap3.9. Filter paper, diameter 90 mm, Schleicher & Schull, Weissband No 5892, or  equivalent3.10. Universal pH indicator paper, pH 1-113.11. 5-ml glass sample vials3.12. Rotating  film evaporator (Rotavapor or equivalent)3.13. Hot plate4. Procedure4.1. Sample prepartionWeigh  approximately 1 g of the sample into a 50-ml glass tube with screw cap (3.8). Add four drops of  hydrochloric acid 4 M (2.8) and 40 ml acetone (2.2). For strongly basic products such as toilet  soap, 20 drops of hydrochloric acid 4 M (2.8) should be added. Check that the pH is approximately  two, using indicator paper (3.10). Close the tube and shake vigorously for one minute. If necessary to facilitate the extrraction of the preservatives into the acetone phase, heat the  mixture gently to about 60 °C to melt the liquid phase. Cool the solution to room temperature and filter through a filter paper (3.9) into a conical  flask. Transfer 20 ml of the filtrate to a 200-ml conical flask, add 20 ml water and mix. Adjust the pH of  the mixture to approximately 10 with potassium hydroxide 4 M (2.9), using indicator paper (3.10) to  measure the pH. Add 1 g calcium chloride (2.10) and shake vigorously. Filter through a filter paper (3.9) into a  250-ml separating funnel containing 75 ml diethyl ether (2.3) and shake vigorously for one minute.  Allow to separate and draw off the aqueous layer into a 250 ml conical flask. Discard the ether  layer. Using indicator paper (3.10), adjust the pH of the aqueous solution to approximately two  with hydrochloric acid 4 M (2.8). Add 10 ml diethyl ether (2.3), stopper the flask and shake  vigorously for one minute. allow to separate and transfer the ether layer to a rotating film  evaporator (3.12). Discard the aqueous layer. Evaporate the ether layer almost to dryness and redissolve the residue in 1 ml of diethyl ether  (2.3). Transfer the solution to a sample vial (3.11). 4.2. Thin layer chromatographyFor each of the references and the samples to be chromatographed,  apply approximately 3µl lithium carbonate solution (2.20) and with a syringe (3.5) at equal  distances on the start line in the concentration zone of a TLC plate (3.4) and dry in a stream of  cold air. Transfer the TLC plate to a hot plate (3.13), heated at 40 °C, in order to keep the spots as small  as possible. With a microsyringe (3.5) apply 10 µl of each of the reference solutions (2.18) and  the sample solution (4.1) to the start line of the plate, on the exact spots where the lithium  carbonate solution has been applied. Finally apply approximately 15 µl derivatization reagent (2.19) (2-bromo-2′-acetonaphthone  solution), again on the exact spots where the reference/sample solutions and the lithium carbonate  solution have been applied. Heat the TLC plate in an oven (3.7) at 80 °C for 45 minutes. After cooling, develop the plate in a  tank (3.2), that has equilibrated for 15 minutes (without the use of filter paper lining), using  development solvent 2.21 (toluene/acetone), until the solvent front has reached a distance of 15 cm  (this may take approximately 80 minutes). Dry the plate in a stream of cold air and examine the spots obtained under UV light (3.3). To  enhance the fluorescence of the weak spots, the TLC plate may be dipped in liquid paraffin/n-hexane  (2.22). 5. IdentificationCalculate the Rf for each spot. Compare the Rf and the behaviour under UV radiation obtained for the sample with that obtained for  the reference solutions. Draw a preliminary conclusion about the presence and identity of the preservatives present. Perform  the HPLC described in Section B, or, when it appears that propionic acid is present, the GC  described in Section C. Compare the retention times obtained with those of the reference  solutions. Combine the results from the TLC and HPLC or GC and base the final identification of the  preservatives present in the sample on the combined results. B. DETERMINATION OF BENZOIC ACID, 4-HYDROXYBENZOIC ACID, SORBIC ACID AND SALICYLIC ACID1.  PrincipleAfter acidification, the sample is extracted with a mixture of ethanol and water.  Following filtration the preservatives are determined by high performance liquid chromatography  (HPLC). 2. Reagents2.1. All reagegnts must be of analytical purity, and suitable for HPLC where  appropriate. Water used must be distilled water, or water of at least equivalent purity2.2.  Ethanol, absolute2.3. 4-Hydroxybenzoic acid2.4. Salicylic acid2.5. Benzoic acid2.6. Sorbic  acid2.7. Sodium acetate, (CH3COONa.3H2O)2.8. Acetic acid, (á)²04= 1,05 g/ml2.9.  Acetonitrile2.10. Sulfuric acid, 2 M2.11. Potassium hydroxide, aqueous, 0,2 M2.12.  2-Methoxybenzoic acid2.13. Ethanol/water mixtureMix nine volumes of ethanol (2.2) and one volume  of water (2:1)2.14. Internal standard solutionPrepare a solution containing approximately 1 g  2-methoxybenzoic acid (2.12) in 500 ml ethanol/water mixture (2.13)2.15. Mobile phase for  HPLC2.15.1. Acetate buffer: to 1 l of water add 6,35 g sodium acetate (2.7) and 20,0 ml acetic  acid (2.8) and mix2.15.2. Prepare the mobile phase by mixing nine volumes acetate buffer (2.15.1)  and one volume acetonitrile (2.9)2.16. Preservative stock solutionAccurately weigh approximately  0,05 g 4-hydroxybenzoic acid (2.3), 0,2 g salicylic acid (2.4), 0,2 g benzoic acid (2.5) and 0,05 g  sorbic acid (2.6) in a 50-ml volumetric flask and make up to volume with ethanol/water mixture  (2.13). Store this solution in a refrigerator. The solution is stable for one week2.17. Standard  preservative solutionsTransfer respectively 8,00, 4,00, 2,00, 1,00 and 0,50 ml of the stock  solution (2.16) into a series of 20-ml volumetric flasks. To each flask, add 10,00 ml internal  standard solution (2.14) and 0,5 ml sulfuric acid 2 M (2.10). Make up to volume with ethanol/water  mixture (2.13). These solutions must be freshly prepared3. ApparatusUsual laboratory equipment  not otherwise specified, and: 3.1. Water bath, set at 60 °C3.2. High performance liquid chromatograph with variable-wavelength  UV detector and 10-µl injection loop3.3. Analytical columnStainless steel, length 12,5 to 25 cm,  internal diameter 4,6 mm, packed with Nucleosil 5C18, or equivalent3.4. Filter paper, diameter: 90  mm, Schleicher and Schull, Weissband No 5892, or equivalent3.5. 50-ml glass tubes with screw  cap3.6. 5-ml glass sample vials3.7. Boiling chips, carborundum, size 2 to 4 mm, or equivalent4.  Procedure4.1. Sample preparation4.1.1. Sample preparation without addition of internal  standardWeigh 1 g of the sample in a 50-ml glass tube with screw cap (3.5). Pipette 1,00 ml  sulfuric acid 2 M (2.10) and 40,0 ml ethanol/water mixture (2.13) into the tube. Add approximately  1 g of boiling chips (3.7), close the tube and shake vigorously for at least one minute until a  homogeneous suspension is obtained. To facilitate the extraction of the preservatives into the  ethanol phase, place the tube for exactly five minutes in a water bath (3.1) kept at 60 °C. Cool the tube immediately in a stream of cold water and store the extract at 5 °C for one hour. Filter the extract through a filter paper (3.4). Transfer approximately 2 ml of the extract into a  sample vial (3.6). Store the extract at 5 °C and perform the HPLC determination within 24 hours of  preparation. 4.1.2. Sample preparation including addition of internal standardWeigh to three decimal places 1 ±  0,1 g (a grams) of the sample in a 50-ml glass tube with screw cap (3.5). Add by pipette 1,00 ml  sulfuric acid 2 M (2.10) and 30,0 ml ethanol/water mixture (2.13). Add approximately 1 g of boiling  chips (3.7) and 10,00 ml internal standard solution (2.14). Close the tube and shake vigorously for  at least one minute until an homogeneous suspension is obtained. To facilitate extraction of the  preservatives into the ethanol phase place the tube for exactly five minutes in a water bath (3.1)  kept at 60 °C. Cool the tube immediately in a stream of cold water and store the extract at 5 °C for one hour. Filter the extract through a filter paper (3.4). Transfer approximately 2 ml of the filtrate into a  sample vial (3.6). Store the filtrate at 5 °C and perform the HPLC-determination within 24 hours of  preparation. 4.2. High performance liquid chromatographyMobile phase: acetonitrile/acetate buffer (2.15). Adjust the flow rate of mobile phase through the column to 2,0 ± 0,5 ml/minute. Set the detector  wavelength to 240 nm. 4.2.1. CalibrationInject 10 µl portions of each of the standard preservative solutions (2.17) into  the liquid chromatography (3.2). For each solution determine the ratios of the peak heights of the  investigated preservatives to the height of the internal standard peak obtained from the  chromatograms. Plot a graph for each preservative relating the peak height ratio to the  concentration of each standard solution. Ascertain that a linear response is obtained for the standard solutions in the calibration  procedure. 4.2.2. DeterminationInject 10 µl of the sample extract (4.1.1) into the liquid chromatograph (3.2)  and record the chromatogram. Inject 10 µl of a standard preservative solution (2.17) and record the  chromatogram. Compare the chromatograms obtained. If in the chromatogram of the sample extract  (4.1.1) no peak appears to be present having approximately the same retention time as  2-methoxybenzoic acid (recommended internal standard), inject 10 µl sample extract with added  internal standard (4.1.2) into the liquid chromatograph and record the chromatogram. If an interfering peak is observed in the chromatogram of the sample extract (4.1.1) having the  same retention time as 2-methoxybenzoic acid, another appropriate internal standard should be  selected. (If one of the preservatives under investigation is absent from the chromatogram, this  preservative can be used as the internal standard.)Ascertain whether the chromatograms obtained  for a standard solution and the sample solution meet the following requirements: - the peak separation of the worst separated pair shall be at least 0,90. (For definition of peak  separation, see figure 1). >REFERENCE TO A FILM>Figure 1: Peak separationOJ No L 231, 14. 9. 1993, p. 34.- If the required  separation is not achieved, either a more efficient column should be used, or the mobile phase  composition should be adjusted until the requirement is met. - The asymmetry factor As of all peaks obtained shall range between 0,9 to 1,5. (For definition of  the peak asymmetry factor, see Figure 2). To record the chromatogram for the determination of the  asymmetry factor a chart speed of at least 2 cm/minute is recommended. >REFERENCE TO A FILM>Figure 2: Peak asymmetry factor- A steady baseline shall be obtained. 5. CalculationUse the ratios of the heights of the peaks of the investigated preservatives to the  height of the 2-methoxybenzoic acid (internal standard) peak and the calibration graph to calculate  the concentration of the acid preservatives in the sample solution. Calculate the benzoic acid,  4-hydroxybenzoic acid, sorbic acid or salicylic acid content of the sample, as a percentage by mass  (xi), using the formula: xi % (m/m) = 100  7 20  7 b 106  7 a = b 500  7 ain which: a = the mass (g) of the test portion (4.1.2), b = the concentration (µg/ml) of the preservative in the sample extract (4.1.2) obtained from the  calibration graph. 6. Repeatability (1)For a 4-hydroxybenzoic acid content of 0,40 % the difference between the  results of two determinations in parallel carried out on the same sample should not exceed an  absolute value of 0,035 %. For a benzoic acid content of 0,50 % the difference between the results of two determinations in  parallel carried out on the same sample should not exceed an absolute value of 0,050 %. For a salicylic acid content of 0,50 % the difference between the results of two determinations in  parallel carried out on the same sample should not exceed an absolute value of 0,045 %. For a sorbic acid content of 0,60 % the difference between the results of two determinations in  parallel carried out on the same sample should not exceed an absolute value of 0,035 %. 7. Remarks7.1. Results of a ruggedness test performed on the method indicated that the amount of  sulfuric acid added to extract the acids from the sample is critical, and the limits for the amount  of sample worked up should be kept within the prescribed boundaries. 7.2. If desired, an appropriate guard column can be used. C. DETERMINATION OF PROPIONIC ACID1. Scope and field of applicationThis method is suitable for  the determination of propionic acid, maximum concentration 2 % (m/m) in cosmetic products. 2. DefinitionThe concentration of propionic acid measured by this method is expressed as a  percentage by mass (% m/m) of the product. 3. PrincipleFollowing extraction of propionic acid from the product determination is performed by  means of gas chromatography with the use of 2-methylpropionic acid as internal standard. 4. ReagentsAll the reagents must be of analytical purity; distilled water or water of equivalent  quality must be used. 4.1. Ethanol 96 % (v/v)4.2. Propionic acid4.3. 2-Methylpropionic acid4.4. Orthophosphoric acid,  10 % (m/v)4.5. Propionic acid solutionAccurately weigh approximately 1,00 g (p grams) of  propionic acid into a 50-ml volumetric flask and make up to volume with ethanol (4.1)4.6. Internal  standard solutionAccurately weigh approximately 1,00 g (e grams) of 2-methylpropionic acid into a  50-ml volumetric flask and make up to volume with ethanol (4.1)5. Apparatus5.1. Usual laboratory  equipment, and: 5.2. Gas chromatograph with flame-ionization detector5.3. Glass tube (20 × 150 mm) with screw  cap5.4. Water bath at 60 °C5.5. 10 ml glass syringe with filter membrane (pore diameter: 0,45  µm)6. Procedure6.1. Sample preparation6.1.1. Sample prepartion without the internal  standardInto a glass tube (5.3), weigh approximately 1 g of the sample. Add 0,5 ml of phosphoric  acid (4.4) and 9,5 ml of ethanol (4.1). Close the tube and shake vigorously. If necessary, place the tube in a water bath heated at 60 °C  (5.4) for five minutes in order to completely dissolve the lipid phase. Cool rapidly under running  water. Filter part of the solution through a membrane filter (5.5). Chromatograph the filtrate the  same day. 6.1.2. Sample preparation with the internal standardWeigh to three decimal places 1 ± 0,1 g (a  grams) of the sample into a glass tube (5.3). Add 0,5 ml of phosphoric acid (4.4), 0,50 ml of the  internal standard solution (4.6) and 9 ml of ethanol (4.1). Close the tube and shake vigorously. If necessary, place the tube in a water bath heated to 60 °C  (5.4) for five minutes in order to dissolve the lipid phase. Cool rapidly under running water.  Filter part of the solution through a membrane filter (5.5). Chromatograph the filtrate the same  day. 6.2. Conditions for gas chromatographyThe following operation conditions are recommended: ColumnType Stainless steelLength 2 mDiameter 1/8 ″ Packing 10 % SPTM 1000 (or equivalent) + 1 % H3PO4 on Chromosorb WAW 100 to 120  meshTemperatureInjector 200 °CColumn 120 °CDetector 200 °CCarrier gas nitrogenFlow rate 25  ml/min6.3. Chromatography6.3.1. CalibrationInto a series of 20-ml volumetric flasks, transfer by  pipette 0,25, 0,50, 1,00, 2,00 and 4,00 ml respectively of the propionic acid solution (4.5). To  each volumetric flask transfer by pipette 1,00 ml of the internal standard solution (4.6); make up  to volume with ethanol (4.1) and mix. The solutions prepared in this way contain e mg/ml of  2-methylpropionic acid as internal standard (that is to say, 1 mg/ml if e = 1 000) and p/4, p/2, p,  2p, 4p mg/ml propionic acid (that is to say, 0,25, 0,50, 1,00, 2,00, 4,00 mg/ml if p = 1 000). Inject 1 µl of each of these solutions and obtain the calibration curve by plotting the ratio of  the propionic acid/2-methylpropionic acid mass on the x-axis and the ratio of the corresponding  peak areas on the y-axis. Make three injections of each solution and calculate the average peak area ratio. 6.3.2. DeterminationInject 1 µl of the sample filtrate 6.1.1. Compare the chromatogram with that  of one of the standard solutions (6.3.1). If a peak has approximately the same retention time as  2-methylpropionic acid, change the internal standard. If no interference is observed, inject 1 µl  of the sample filtrate 6.1.2 and measure the areas of the propionic acid peak and the internal  standard peak. Make three injections of each solution and calculate the average peak area ratio. 7. Calculations7.1. From the calibration curve obtained in 6.3.1, obtain the ratio of mass (K)  corresponding to the peak area ratio calculated in 6.3.2. 7.2. From the ratio of mass thus obtained calculate the propionic acid content of the sampe (X) as  a percentage by mass using the formula: x % (m/m) = K 0,5  7 100  7 e 50  7 a = K e ain which: K = the ratio calculated in 7.1, e = mass in grams of the internal standard weighed in 4.6, a = mass in grams of the sample weighed in 6.1.2. Round off results to one decimal place. 8. Repeatability (1)For a propionic acid content of 2 % (m/m) the difference between the results  of two determinations in parallel carried out on the same sample should not exceed 0,12 %. II. IDENTIFICATION AND DETERMINATION OF HYDROQUINONE, HYDROQUINONE MONOMETHYLETHER, HYDROQUINONE  MONOETHYLETHER AND HYDROQUINONE MONOBENZYLETHER IN COSMETIC PRODUCTSA. IDENTIFICATION1. Scope  and field of applicationThe method describes the detection and identification of hydroquinone,  hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether  (monobenzone) in cosmetic products for lightening the skin. 2. PrincipleHydroquinone and its ethers are identified by thin layer chromatography (TLC). 3. ReagentsAll reagents must be of analytical grade. 3.1. Ethanol, 96 % (v/v)3.2. Chloroform3.3. Diethyl ether3.4. Developing solvent: Chloroform/Diethyl ether, 66:33 (v/v)3.5. Ammonia, 25 % (m/m) (d²04 = 0,91 g/ml)3.6. Ascorbic  acid3.7. Hydroquinone3.8. Hydroquinone monomethylether3.9. Hydroquinone monoethylether3.10.  Hydroquinone monobenzylether (monobenzone)3.11. Reference solutionsThe following reference  solutions should be freshly prepared, and are stable for one day. 3.11.1. Weigh 0,05 g hydroquinone (3.7) into a 10-ml graduated test tube. Add 0,250 g of ascorbic  acid (3.6) and 5 ml of ethanol (3.1). Add ammonia (3.5) until the pH is 10 and make up to a volume  of 10 ml with ethanol (3.1). 3.11.2. Weigh 0,05 g hydroquinone monomethylether (3.8) into a 10-ml graduated test tube. Add 0,250  g of ascorbic acid (3.6) and 5 ml of ethanol (3.1). Add ammonia (3.5) until the pH is 10 and make  up to a volume of 10ml with ethanol (3.1). 3.11.3. Weigh 0,05 g hydroquinone monoethylether (3.9) into a 10-ml graduated test tube. Add 0,250  g of ascorbic acid (3.6) and 5 ml of ethanol (3.1). Add ammonia (3.5) until the pH is 10 and make  up to a volume of 10ml with ethanol (3.1). 3.11.4. Weigh 0,05 g hydroquinone monobenzylether (3.10) into a 10-ml graduated test tube. Add  0,250 g of ascorbic acid (3.6) and 5 ml of ethanol (3.1). Add ammonia (3.5) until the pH is 10 and  make up to a volume of 10ml with ethanol (3.1). 3.12. Silver nitrate3.13. 12-Molybdophosphoric acid3.14. Potassium ferricyanide hexahydrate3.15.  Ferric chloride, hexahydrate3.16. Spray reagents3.16.1. To a 5 % (m/v) aqueous solution of silver  nitrate (3.12), add ammonia (3.5) until the precipitate that forms dissolves. Warning: the solution becomes explosively unstable on standing and should be discarded after use. 3.16.2. 10 % (m/v) solution of 12-molybdophosphoric acid (3.13) in ethanol (3.1). 3.16.3. Prepare a 1 % (m/v) aqueous solution of potassium ferricyanide (3.14) and a 2 % (m/v)  aqueous solution of ferric chloride (3.15). Mix equal parts of both solutions just before use. 4. ApparatusNormal laboratory equipment, and: 4.1. Usual TLC equipment4.2. TLC plates, ready for use: silica gel GHR/UV254; 20 × 20 cm (Machery,  Nagel, or equivalent). Layer thickness 0,25 mm4.3. Ultrasonic bath4.4. Centrifuge4.5. UV lamp,  254 nm5. Procedure5.1. Preparation of the sampleWeigh 3,0 g of sample into a 10-ml graduated  tube. Add 0,250 g of ascorbic acid (3.6) and 5 ml of ethanol (3.1). Adjust the pH of the solution  to 10, using amonia (3.5). Make up to a volume of 10 ml with ethanol (3.1). Close the tube with a  stopper and homogenize in an ultrasonic bath for 10 minutes. Filter through a filter paper or  centrifuge at 3 000 rpm. 5.2. TLC5.2.1. Saturate a chromatographic tank with developing solvent (3.4). 5.2.2. Deposit on a plate 2 µl of the reference solutions (3.11) and 2 µl of the sample solution  (5.1). Develop in the dark at ambient temperature until the solvent front has migrated 15 cm from  the start. 5.2.3. Remove the plate and allow to dry at room temperature. 5.3. Detection5.3.1. Observe the plate under UV light at 254 nm, and mark the position of the  spots. 5.3.2. Spray the plate with: - silver nitrate reagent (3.16.1), or- 12-molybdophosphoric acid reagent (3.16.2); heat to  approximately 120 °C, or- potassium ferricyanide solution and ferric chloride solution (3.16.3). 6. IdentificationCalculate the Rf value for each spot. Compare the spots obtained for the sample solution with those for the reference solutions with  respect to: their Rf values; the colour of the spots under UV radiation; and the colours of the  spots after visualization with the spray reagent. Perform the HPLC described in the following section (B), and compare the retention times obtained  for the sample peak(s) with those for the reference solutions. Combine the results from TLC and HPLC to identify the presence of hydroquinone and/or its ethers. 7. RemarksUnder the conditions described, the following Rf values were observed: hydroquinone: 0,32hydroquinone monomethylether: 0,53hydroquinone monoethylether:  0,55hydroquinone monobenzylether: 0,58B. DETERMINATION1. Scope and field of applicationThis  method specifies a procedure for the determination of hydroquinone, hydroquinone monomethylether,  hydroquinone monoethylether and hydroquinone monobenzylether in cosmetic products for lightening  the skin. 2. PrincipleThe sample is extracted with a water/methanol mixture under gentle heating to melt any  lipid material. Determination of the analytes in the resulting solution is performed by reversed  phase liquid chromatography with UV detection. 3. Reagents3.1. All reagents must be of analytical quality. Water used must be distilled water, or  water of at least equivalent purity3.2. Methanol3.3. Hydroquinone3.4. Hydroquinone  monomethylether3.5. Hydroquinone monethylether3.6. Hydroquinone monobenzylether  (monobenzone)3.7. Tetrahydrofuran, HPLC grade3.8. Water/methanol mixture 1:1 (v/v). Mix one  volume of water and one volume of methanol (3.2)3.9. Mobile phase: tetrahydrofuran/water mixture  45:55 (v/v). Mix 45 volumes of tetrahydrofuran (3.7) and 55 volumes of water3.10. Reference  solutionWeigh 0,06 g of hydroquinone (3.3), 0,08 g hydroquinone monomethylether (3.4), 0,10 g  hydroquinone monoethylether (3.5) and 0,12 g hydroquinone monobenzylether (3.6) into a 50-ml  volumetric flask. Dissolve and make up to volume with methanol (3.2). Prepare the reference  solution by diluting 10,00 ml of this solution to 50,00 ml with water/methanol mixture (3.8). These  solutions must be freshly prepared. 4. ApparatusNormal laboratory equipment and: 4.1. Water bath, capable of maintaining a temperature of 60 °C4.2. High-performance liquid  chromatograph with a variable-wavelength UV detector and 10-µl injection loop4.3. Analytical  column: Stainless steel chromatographic column, length 250 mm, internal diameter 4,6 mm, packed with Zorbax  phenyl (chemically bonded phenethylsilane on Zorbax SIL, end-capped with trimethylchlorosilane),  particle size 6 µm, or equivalent. Do not use a guard column, except phenyl guard, or  equivalent4.4. Filter paper, diameter 90 mm, Schleicher and Schull, Weissband No 5892, or  equivalent5. Procedure5.1. Sample preparationWeigh to three decimal places 1 ± 0,1 g (a gram) of  sample into a 50-ml volumetric flask. Disperse the sample in 25 ml water/methanol mixture (3.8).  Close the flask and shake vigorously until a homogeneous suspension is obtained. Shake for at least  one minute. Place the flask in a water bath (4.1) kept at 60 °C to enhance the extraction. Cool the  flask, and make up to volume with water/methanol (3.8). Filter the extract using a filter paper  (4.4). Perform the HPLC determination within 24 hours of preparing the extract. 5.2. High performance liquid chromatography. 5.2.1. Adjust the flow rate of the mobile phase (3.9) to 1,0 ml/min and set the detector wavelength  to 295 nm. 5.2.2. Inject 10 µl of the sample solution obtained as described in section 5.1, and record the  chromatogram. Measure the peak areas. Perform a calibration as described under 5.2.3. Compare the  chromatograms obtained for sample and standard solutions. Use the peak aeras and the response  factors (RF) calculated under 5.2.3 to calculate the concentration of the analytes in the sample  solution. 5.2.3. CalibrationInject 10 µl of the reference solution (3.10) and record the chromatogram.  Inject several times until a constant peak area is obtained. Determine the response factor RFi: RFi = pi ciin which: pi = peak area for hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether or  hydroquinone monobenzylether, andci = concentration (g/50 ml) in the reference solution (3.10) of  hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether or hydroquinone  monobenzylether. Ascertain whether the chromatograms obtained for a standard solution and the sample solution meet  the following requirements: - the peak separation of the worst separated pair shall be at least 0,90. (For definition of peak  separation, see Figure 1.)>REFERENCE TO A FILM>Figure 1: Peak separationIf the required  separation is not achieved, either a more efficient column should be used, or the mobile phase  composition should be adjusted until the requirement is met. - The asymmetry factor AS, of all peaks obtained shall range between 0,9 to 1,5. (For definition of  the peak asymmetry factor, see Figure 2.) To record the chromatogram for the determination of the  asymmetry factor a chart speed of at lest 2 cm/min is recommended. >REFERENCE TO A FILM>Figure 2: Peak asymmetry factor- A steady baseline shall be obtained. 6. CalculationUse the areas of the analyte peaks to calculate the concentration(s) of the  analyte(s) in the sample. Calculate the analyte concentration in the sample, as a percentage by  mass, (xi) using the formula: xi % (m/m) = bi  7 100 RFi  7 ain which: a= mass of the sample in grams, andbi = peak area of analyte i in the sample. 7. Repeatability (1)7.1. For a hydroquinone content of 2,0 % the difference between the results of  two determinations carried out in parallel on the same sample should not exceed an absolute value  of 0,13 %. 7.2. For a hydroquinone monomethylether content of 1,0 % the difference between the results of two  determinations carried out in parallel on the same sample should not exceed an absolute value of  0,1 %. 7.3. For a hydroquinone monoethylether content of 1,0 % the difference between the results of two  determinations carried out in parallel on the same sample should not exceed an absolute value of  0,11 %. 7.4. For a hydroquinone monobenzylether content of 1,0 % the difference between the results of two  determinations carried out in parallel on the same sample should not exceed an absolute value of  0,11 %. 8. Reproducibility (1)8.1. For a hydroquinone content of 2,0 % the difference between the results  of two determinations carried out on the same sample under different conditions (different  laboratories, different operators, different apparatus and/or different time) should not exceed an  absolute value of 0,37 %. 8.2. For a hydroquinone monomethylether content of 1,0 % the difference between the results of two  determinations carried out on the same sample under different conditions (different laboratories,  different operators, different apparatus and/or different time) should not exceed an absolute value  of 0,21 %. 8.3. For a hydroquinone monoethylether content of 1,0 % the difference between the results of two  determinations carried out on the same sample under different conditions (different laboratories,  different operators, different apparatus and/or different time) should not exceed an absolute value  of 0,19 %. 8.4. For a hydroquinone monobenzylether content of 1,0 % the difference between the results of two  determinations carried out on the same sample under different conditions (different laboratories,  different operators, different apparatus and/or different time) should not exceed an absolute value  of 0,11 %. 9. Remarks9.1. When a hydroquinone content considerably higher than 2 % is found and an accurate  estimate of the content is required, the sample extract (5.1) should be diluted to a similar  concentration as would be obtained from a sample containing 2 % hydroquinone, and the determination  repeated. (In some instruments the absorbance may be out of the linear range of the detector for high  hydroquinone concentrations.)9.2. InterferencesThe method described above allows the  determination of hydroquinone and its ethers in a single isocratic run. The use of the phenyl  column assures sufficient retention for hydroquinone, which cannot be guaranteed when a C18 column  is used with the mobile phase described. However, this method is prone to interferences by a number of parabens. In such cases the  determination should be repeated employing a different mobile phase/stationary phase system.  Suitable methods may be found in references 1 and 2, namely: Column: Zorbax ODS, 4,6 mm × 25 mm, or equivalent: temperaure: 36 °Cflow: 1,5 ml/minmobile phase: for hydroquinone: methanol/water 5/95 (V/V)for hydroquinone monomethylether: methanol/water 30/70  (V/V)for hydroquinone monobenzylether: methanol/water 80/20 (V/V) (1). Column: Spherisorb S5-ODS, or equivalent: mobile phase: water/methanol 90/10 (V/V)flow: 1,5 ml/min. These conditions are suitable for hydroquinone (2). (1) ISO 5725. (1) ISO 5725. (1) ISO 5725. (1) M. Herpol-Borremans et M.-O. Masse, Identification et dosage de l'hydroquinone et de ses éthers  méthylique et benzylique dans les produits cosmétiques pour blanchir la peau. Int. j. Cosmet. Sci.  8-203-214 (1986). (2) J. Firth and I. Rix, Determination of hydroquinone in skin toning creams, Analyst (1986), 111,  p. 129.


title: Directive 2011/77/EU of the European Parliament and of the Council of 27 September 2011 amending Directive 2006/116/EC on the term of protection of copyright and certain related rights

text:
               11.10.2011

               EN

               Official Journal of the European Union

               L 265/1

         DIRECTIVE 2011/77/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 27 September 2011
   amending Directive 2006/116/EC on the term of protection of copyright and certain related rights
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 53(1), 62 and 114 thereof,
   Having regard to the proposal from the European Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the ordinary legislative procedure (2),
   Whereas:

               (1)

               Under Directive 2006/116/EC of the European Parliament and of the Council (3), the term of protection for performers and producers of phonograms is 50 years.

               (2)

               In the case of performers this period starts with the performance or, when the fixation of the performance is lawfully published or lawfully communicated to the public within 50 years after the performance is made, with the first such publication or the first such communication to the public, whichever is the earliest.

               (3)

               For phonogram producers the period starts with the fixation of the phonogram or its lawful publication within 50 years after fixation, or, if it is not so published, its lawful communication to the public within 50 years after fixation.

               (4)

               The socially recognised importance of the creative contribution of performers should be reflected in a level of protection that acknowledges their creative and artistic contribution.

               (5)

               Performers generally start their careers young and the current term of protection of 50 years applicable to fixations of performances often does not protect their performances for their entire lifetime. Therefore, some performers face an income gap at the end of their lifetime. In addition, performers are often unable to rely on their rights to prevent or restrict an objectionable use of their performances that may occur during their lifetime.

               (6)

               The revenue derived from the exclusive rights of reproduction and making available, as provided for in Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (4), as well as fair compensation for reproductions for private use within the meaning of that Directive, and from the exclusive rights of distribution and rental within the meaning of Directive 2006/115/EC of the European Parliament and of the Council of 12 December 2006 on rental right and lending right and on certain rights related to copyright in the field of intellectual property (5), should be available to performers for at least their lifetime.

               (7)

               The term of protection for fixations of performances and for phonograms should therefore be extended to 70 years after the relevant event.

               (8)

               The rights in the fixation of the performance should revert to the performer if a phonogram producer refrains from offering for sale in sufficient quantity, within the meaning of the International Convention on the Protection of Performers, Producers of Phonograms and Broadcasting Organisations, copies of a phonogram which, but for the term extension, would be in the public domain, or refrains from making such a phonogram available to the public. That option should be available on expiry of a reasonable period of time for the phonogram producer to carry out both of these acts of exploitation. The rights of the phonogram producer in the phonogram should therefore expire, in order to avoid a situation in which these rights would coexist with those of the performer in the fixation of the performance while the latter rights are no longer transferred or assigned to the phonogram producer.

               (9)

               Upon entering into a contractual relationship with a phonogram producer, performers normally have to transfer or assign to the phonogram producer their exclusive rights of reproduction, distribution, rental and making available of fixations of their performances. In exchange, some performers are paid an advance on royalties and enjoy payments only once the phonogram producer has recouped the initial advance and made any contractually defined deductions. Other performers transfer or assign their exclusive rights in return for a one-off payment (non-recurring remuneration). This is particularly the case for performers who play in the background and do not appear in the credits (non-featured performers) but sometimes also for performers who appear in the credits (featured performers).

               (10)

               In order to ensure that performers who have transferred or assigned their exclusive rights to phonogram producers actually benefit from the term extension, a series of accompanying measures should be introduced.

               (11)

               A first accompanying measure should be the imposition on phonogram producers of an obligation to set aside, at least once a year, a sum corresponding to 20 % of the revenue from the exclusive rights of distribution, reproduction and making available of phonograms. ‘Revenue’ means the revenue derived by the phonogram producer before deducting costs.

               (12)

               Payment of those sums should be reserved solely for the benefit of performers whose performances are fixed in a phonogram and who have transferred or assigned their rights to the phonogram producer in return for a one-off payment. The sums set aside in this manner should be distributed to non-featured performers at least once a year on an individual basis. Such distribution should be entrusted to collecting societies and national rules on non-distributable revenue may be applied. In order to avoid the imposition of a disproportionate burden in the collection and administration of that revenue, Member States should be able to regulate the extent to which micro-enterprises are subject to the obligation to contribute where such payments would appear unreasonable in relation to the costs of collecting and administering such revenue.

               (13)

               However, Article 5 of Directive 2006/115/EC already grants performers an unwaivable right to equitable remuneration for the rental of, inter alia, phonograms. Likewise, in contractual practice performers do not usually transfer or assign to phonogram producers their rights to claim a single equitable remuneration for broadcasting and communication to the public under Article 8(2) of Directive 2006/115/EC and to fair compensation for reproductions for private use under point (b) of Article 5(2) of Directive 2001/29/EC. Therefore, in the calculation of the overall amount to be dedicated by a phonogram producer to payments of the supplementary remuneration, no account should be taken of revenue which the phonogram producer has derived from the rental of phonograms, of the single equitable remuneration received for broadcasting and communication to the public or of the fair compensation received for private copying.

               (14)

               A second accompanying measure designed to rebalance contracts whereby performers transfer their exclusive rights on a royalty basis to a phonogram producer, should be a ‘clean slate’ for those performers who have assigned their above-mentioned exclusive rights to phonogram producers in return for royalties or remuneration. In order for performers to benefit fully from the extended term of protection, Member States should ensure that, under agreements between phonogram producers and performers, a royalty or remuneration rate unencumbered by advance payments or contractually defined deductions is paid to performers during the extended period.

               (15)

               For the sake of legal certainty it should be provided that, in the absence of clear indications to the contrary in the contract, a contractual transfer or assignment of rights in the fixation of the performance concluded before the date by which Member States are to adopt measures implementing this Directive shall continue to produce its effects for the extended term.

               (16)

               Member States should be able to provide that certain terms in those contracts which provide for recurring payments can be renegotiated for the benefit of performers. Member States should have procedures in place to cover the eventuality that the renegotiation fails.

               (17)

               This Directive should not affect national rules and agreements which are compatible with its provisions, such as collective agreements concluded in Member States between organisations representing performers and organisations representing producers.

               (18)

               In some Member States, musical compositions with words are given a single term of protection, calculated from the death of the last surviving author, while in other Member States separate terms of protection apply for music and lyrics. Musical compositions with words are overwhelmingly co-written. For example, an opera is often the work of a librettist and a composer. Moreover, in musical genres such as jazz, rock and pop music, the creative process is often collaborative in nature.

               (19)

               Consequently, the harmonisation of the term of protection in respect of musical compositions with words the lyrics and music of which were created in order to be used together is incomplete, giving rise to obstacles to the free movement of goods and services, such as cross-border collective management services. In order to ensure the removal of such obstacles, all such works in protection at the date by which the Member States are required to transpose this Directive should have the same harmonised term of protection in all Member States.

               (20)

               Directive 2006/116/EC should therefore be amended accordingly.

               (21)

               Since the objectives of the accompanying measures cannot be sufficiently achieved by the Member States, inasmuch as national measures in that field would either lead to distortion of competition or affect the scope of exclusive rights of the phonogram producer which are defined by Union legislation, and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

               (22)

               In accordance with point 34 of the interinstitutional agreement on better law-making (6), Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables which will, as far as possible, illustrate the correlation between this Directive and their transposition measures, and to make them public,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments to Directive 2006/116/EC
   Directive 2006/116/EC is hereby amended as follows:

               (1)

               The following paragraph shall be added to Article 1:
               ‘7.   The term of protection of a musical composition with words shall expire 70 years after the death of the last of the following persons to survive, whether or not those persons are designated as co-authors: the author of the lyrics and the composer of the musical composition, provided that both contributions were specifically created for the respective musical composition with words.’.

               (2)

               Article 3 shall be amended as follows:

                           (a)

                           in paragraph 1, the second sentence shall be replaced by the following:
                           ‘However,

                                       —

                                       if a fixation of the performance otherwise than in a phonogram is lawfully published or lawfully communicated to the public within this period, the rights shall expire 50 years from the date of the first such publication or the first such communication to the public, whichever is the earlier,

                                       —

                                       if a fixation of the performance in a phonogram is lawfully published or lawfully communicated to the public within this period, the rights shall expire 70 years from the date of the first such publication or the first such communication to the public, whichever is the earlier.’;

                           (b)

                           in the second and third sentences of paragraph 2, the number ‘50’ shall be replaced by ‘70’;

                           (c)

                           the following paragraphs shall be inserted:
                           ‘2a.   If, 50 years after the phonogram was lawfully published or, failing such publication, 50 years after it was lawfully communicated to the public, the phonogram producer does not offer copies of the phonogram for sale in sufficient quantity or does not make it available to the public, by wire or wireless means, in such a way that members of the public may access it from a place and at a time individually chosen by them, the performer may terminate the contract by which the performer has transferred or assigned his rights in the fixation of his performance to a phonogram producer (hereinafter a “contract on transfer or assignment”). The right to terminate the contract on transfer or assignment may be exercised if the producer, within a year from the notification by the performer of his intention to terminate the contract on transfer or assignment pursuant to the previous sentence, fails to carry out both of the acts of exploitation referred to in that sentence. This right to terminate may not be waived by the performer. Where a phonogram contains the fixation of the performances of a plurality of performers, they may terminate their contracts on transfer or assignment in accordance with applicable national law. If the contract on transfer or assignment is terminated pursuant to this paragraph, the rights of the phonogram producer in the phonogram shall expire.
                           2b.   Where a contract on transfer or assignment gives the performer a right to claim a non-recurring remuneration, the performer shall have the right to obtain an annual supplementary remuneration from the phonogram producer for each full year immediately following the 50th year after the phonogram was lawfully published or, failing such publication, the 50th year after it was lawfully communicated to the public. The right to obtain such annual supplementary remuneration may not be waived by the performer.
                           2c.   The overall amount to be set aside by a phonogram producer for payment of the annual supplementary remuneration referred to in paragraph 2b shall correspond to 20 % of the revenue which the phonogram producer has derived, during the year preceding that for which the said remuneration is paid, from the reproduction, distribution and making available of the phonogram in question, following the 50th year after it was lawfully published or, failing such publication, the 50th year after it was lawfully communicated to the public.
                           Member States shall ensure that phonogram producers are required on request to provide to performers who are entitled to the annual supplementary remuneration referred to in paragraph 2b any information which may be necessary in order to secure payment of that remuneration.
                           2d.   Member States shall ensure that the right to obtain an annual supplementary remuneration as referred to in paragraph 2b is administered by collecting societies.
                           2e.   Where a performer is entitled to recurring payments, neither advance payments nor any contractually defined deductions shall be deducted from the payments made to the performer following the 50th year after the phonogram was lawfully published or, failing such publication, the 50th year after it was lawfully communicated to the public.’.

               (3)

               The following paragraphs shall be added to Article 10:
               ‘5.   Article 3(1) to (2e) in the version thereof in force on 31 October 2011 shall apply to fixations of performances and phonograms in regard to which the performer and the phonogram producer are still protected, by virtue of those provisions in the version thereof in force on 30 October 2011, as at 1 November 2013 and to fixations of performances and phonograms which come into being after that date.
               6.   Article 1(7) shall apply to musical compositions with words of which at least the musical composition or the lyrics are protected in at least one Member State on 1 November 2013, and to musical compositions with words which come into being after that date.
               The first subparagraph of this paragraph shall be without prejudice to any acts of exploitation performed before 1 November 2013. Member States shall adopt the necessary provisions to protect, in particular, acquired rights of third parties.’.

               (4)

               The following Article shall be inserted:
               ‘Article 10a
               Transitional measures
               1.   In the absence of clear contractual indications to the contrary, a contract on transfer or assignment concluded before 1 November 2013 shall be deemed to continue to produce its effects beyond the moment at which, by virtue of Article 3(1) in the version thereof in force on 30 October 2011, the performer would no longer be protected.
               2.   Member States may provide that contracts on transfer or assignment which entitle a performer to recurring payments and which are concluded before 1 November 2013 can be modified following the 50th year after the phonogram was lawfully published or, failing such publication, the 50th year after it was lawfully communicated to the public.’.

         Article 2
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 November 2013. They shall forthwith inform the Commission thereof.
   When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   Reporting
   1.   By 1 November 2016, the Commission shall submit to the European Parliament, the Council and the European Economic and Social Committee a report on the application of this Directive in the light of the development of the digital market, accompanied, where appropriate, by a proposal for the further amendment of Directive 2006/116/EC.
   2.   By 1 January 2012, the Commission shall submit a report to the European Parliament, the Council and the European Economic and Social Committee, assessing the possible need for an extension of the term of protection of rights to performers and producers in the audiovisual sector. If appropriate, the Commission shall submit a proposal for the further amendment of Directive 2006/116/EC.
   Article 4
   Entry into force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 27 September 2011.

            For the European Parliament

            The President

         J. BUZEK

            For the Council

            The President

         M. DOWGIELEWICZ

      (1)  OJ C 182, 4.8.2009, p. 36.

      (2)  Position of the European Parliament of 23 April 2009 (OJ C 184 E, 8.7.2010, p. 331) and Decision of the Council of 12 September 2011.

      (3)  OJ L 372, 27.12.2006, p. 12.

      (4)  OJ L 167, 22.6.2001, p. 10.

      (5)  OJ L 376, 27.12.2006, p. 28.

      (6)  OJ C 321, 31.12.2003, p. 1.


Avis juridique important

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32002L0014

Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a general framework for informing and consulting employees in the European Community - Joint declaration of the European Parliament, the Council and the Commission on employee representation

Official Journal L 080 , 23/03/2002 P. 0029 - 0034

Directive 2002/14/EC of the European Parliament and of the Councilof 11 March 2002establishing a general framework for informing and consulting employees in the European CommunityTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Having regard to the opinion of the Committee of the Regions(3),Acting in accordance with the procedure referred to in Article 251(4), and in the light of the joint text approved by the Conciliation Committee on 23 January 2002,Whereas:(1) Pursuant to Article 136 of the Treaty, a particular objective of the Community and the Member States is to promote social dialogue between management and labour.(2) Point 17 of the Community Charter of Fundamental Social Rights of Workers provides, inter alia, that information, consultation and participation for workers must be developed along appropriate lines, taking account of the practices in force in different Member States.(3) The Commission consulted management and labour at Community level on the possible direction of Community action on the information and consultation of employees in undertakings within the Community.(4) Following this consultation, the Commission considered that Community action was advisable and again consulted management and labour on the contents of the planned proposal; management and labour have presented their opinions to the Commission.(5) Having completed this second stage of consultation, management and labour have not informed the Commission of their wish to initiate the process potentially leading to the conclusion of an agreement.(6) The existence of legal frameworks at national and Community level intended to ensure that employees are involved in the affairs of the undertaking employing them and in decisions which affect them has not always prevented serious decisions affecting employees from being taken and made public without adequate procedures having been implemented beforehand to inform and consult them.(7) There is a need to strengthen dialogue and promote mutual trust within undertakings in order to improve risk anticipation, make work organisation more flexible and facilitate employee access to training within the undertaking while maintaining security, make employees aware of adaptation needs, increase employees' availability to undertake measures and activities to increase their employability, promote employee involvement in the operation and future of the undertaking and increase its competitiveness.(8) There is a need, in particular, to promote and enhance information and consultation on the situation and likely development of employment within the undertaking and, where the employer's evaluation suggests that employment within the undertaking may be under threat, the possible anticipatory measures envisaged, in particular in terms of employee training and skill development, with a view to offsetting the negative developments or their consequences and increasing the employability and adaptability of the employees likely to be affected.(9) Timely information and consultation is a prerequisite for the success of the restructuring and adaptation of undertakings to the new conditions created by globalisation of the economy, particularly through the development of new forms of organisation of work.(10) The Community has drawn up and implemented an employment strategy based on the concepts of "anticipation", "prevention" and "employability", which are to be incorporated as key elements into all public policies likely to benefit employment, including the policies of individual undertakings, by strengthening the social dialogue with a view to promoting change compatible with preserving the priority objective of employment.(11) Further development of the internal market must be properly balanced, maintaining the essential values on which our societies are based and ensuring that all citizens benefit from economic development.(12) Entry into the third stage of economic and monetary union has extended and accelerated the competitive pressures at European level. This means that more supportive measures are needed at national level.(13) The existing legal frameworks for employee information and consultation at Community and national level tend to adopt an excessively a posteriori approach to the process of change, neglect the economic aspects of decisions taken and do not contribute either to genuine anticipation of employment developments within the undertaking or to risk prevention.(14) All of these political, economic, social and legal developments call for changes to the existing legal framework providing for the legal and practical instruments enabling the right to be informed and consulted to be exercised.(15) This Directive is without prejudice to national systems regarding the exercise of this right in practice where those entitled to exercise it are required to indicate their wishes collectively.(16) This Directive is without prejudice to those systems which provide for the direct involvement of employees, as long as they are always free to exercise the right to be informed and consulted through their representatives.(17) Since the objectives of the proposed action, as outlined above, cannot be adequately achieved by the Member States, in that the object is to establish a framework for employee information and consultation appropriate for the new European context described above, and can therefore, in view of the scale and impact of the proposed action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve these objectives.(18) The purpose of this general framework is to establish minimum requirements applicable throughout the Community while not preventing Member States from laying down provisions more favourable to employees.(19) The purpose of this general framework is also to avoid any administrative, financial or legal constraints which would hinder the creation and development of small and medium-sized undertakings. To this end, the scope of this Directive should be restricted, according to the choice made by Member States, to undertakings with at least 50 employees or establishments employing at least 20 employees.(20) This takes into account and is without prejudice to other national measures and practices aimed at fostering social dialogue within companies not covered by this Directive and within public administrations.(21) However, on a transitional basis, Member States in which there is no established statutory system of information and consultation of employees or employee representation should have the possibility of further restricting the scope of the Directive as regards the numbers of employees.(22) A Community framework for informing and consulting employees should keep to a minimum the burden on undertakings or establishments while ensuring the effective exercise of the rights granted.(23) The objective of this Directive is to be achieved through the establishment of a general framework comprising the principles, definitions and arrangements for information and consultation, which it will be for the Member States to comply with and adapt to their own national situation, ensuring, where appropriate, that management and labour have a leading role by allowing them to define freely, by agreement, the arrangements for informing and consulting employees which they consider to be best suited to their needs and wishes.(24) Care should be taken to avoid affecting some specific rules in the field of employee information and consultation existing in some national laws, addressed to undertakings or establishments which pursue political, professional, organisational, religious, charitable, educational, scientific or artistic aims, as well as aims involving information and the expression of opinions.(25) Undertakings and establishments should be protected against disclosure of certain particularly sensitive information.(26) The employer should be allowed not to inform and consult where this would seriously damage the undertaking or the establishment or where he has to comply immediately with an order issued to him by a regulatory or supervisory body.(27) Information and consultation imply both rights and obligations for management and labour at undertaking or establishment level.(28) Administrative or judicial procedures, as well as sanctions that are effective, dissuasive and proportionate in relation to the seriousness of the offence, should be applicable in cases of infringement of the obligations based on this Directive.(29) This Directive should not affect the provisions, where these are more specific, of Council Directive 98/59/EC of 20 July 1998 on the approximation of the laws of the Member States relating to collective redundancies(5) and of Council Directive 2001/23/EC of 12 March 2001 on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses(6).(30) Other rights of information and consultation, including those arising from Council Directive 94/45/EEC of 22 September 1994 on the establishment of a European Works Council or a procedure in Community-scale undertakings and Community-scale groups of undertakings for the purposes of informing and consulting employees(7), should not be affected by this Directive.(31) Implementation of this Directive should not be sufficient grounds for a reduction in the general level of protection of workers in the areas to which it applies,HAVE ADOPTED THIS DIRECTIVE:Article 1Object and principles1. The purpose of this Directive is to establish a general framework setting out minimum requirements for the right to information and consultation of employees in undertakings or establishments within the Community.2. The practical arrangements for information and consultation shall be defined and implemented in accordance with national law and industrial relations practices in individual Member States in such a way as to ensure their effectiveness.3. When defining or implementing practical arrangements for information and consultation, the employer and the employees' representatives shall work in a spirit of cooperation and with due regard for their reciprocal rights and obligations, taking into account the interests both of the undertaking or establishment and of the employees.Article 2DefinitionsFor the purposes of this Directive:(a) "undertaking" means a public or private undertaking carrying out an economic activity, whether or not operating for gain, which is located within the territory of the Member States;(b) "establishment" means a unit of business defined in accordance with national law and practice, and located within the territory of a Member State, where an economic activity is carried out on an ongoing basis with human and material resources;(c) "employer" means the natural or legal person party to employment contracts or employment relationships with employees, in accordance with national law and practice;(d) "employee" means any person who, in the Member State concerned, is protected as an employee under national employment law and in accordance with national practice;(e) "employees' representatives" means the employees' representatives provided for by national laws and/or practices;(f) "information" means transmission by the employer to the employees' representatives of data in order to enable them to acquaint themselves with the subject matter and to examine it;(g) "consultation" means the exchange of views and establishment of dialogue between the employees' representatives and the employer.Article 3Scope1. This Directive shall apply, according to the choice made by Member States, to:(a) undertakings employing at least 50 employees in any one Member State, or(b) establishments employing at least 20 employees in any one Member State.Member States shall determine the method for calculating the thresholds of employees employed.2. In conformity with the principles and objectives of this Directive, Member States may lay down particular provisions applicable to undertakings or establishments which pursue directly and essentially political, professional organisational, religious, charitable, educational, scientific or artistic aims, as well as aims involving information and the expression of opinions, on condition that, at the date of entry into force of this Directive, provisions of that nature already exist in national legislation.3. Member States may derogate from this Directive through particular provisions applicable to the crews of vessels plying the high seas.Article 4Practical arrangements for information and consultation1. In accordance with the principles set out in Article 1 and without prejudice to any provisions and/or practices in force more favourable to employees, the Member States shall determine the practical arrangements for exercising the right to information and consultation at the appropriate level in accordance with this Article.2. Information and consultation shall cover:(a) information on the recent and probable development of the undertaking's or the establishment's activities and economic situation;(b) information and consultation on the situation, structure and probable development of employment within the undertaking or establishment and on any anticipatory measures envisaged, in particular where there is a threat to employment;(c) information and consultation on decisions likely to lead to substantial changes in work organisation or in contractual relations, including those covered by the Community provisions referred to in Article 9(1).3. Information shall be given at such time, in such fashion and with such content as are appropriate to enable, in particular, employees' representatives to conduct an adequate study and, where necessary, prepare for consultation.4. Consultation shall take place:(a) while ensuring that the timing, method and content thereof are appropriate;(b) at the relevant level of management and representation, depending on the subject under discussion;(c) on the basis of information supplied by the employer in accordance with Article 2(f) and of the opinion which the employees' representatives are entitled to formulate;(d) in such a way as to enable employees' representatives to meet the employer and obtain a response, and the reasons for that response, to any opinion they might formulate;(e) with a view to reaching an agreement on decisions within the scope of the employer's powers referred to in paragraph 2(c).Article 5Information and consultation deriving from an agreementMember States may entrust management and labour at the appropriate level, including at undertaking or establishment level, with defining freely and at any time through negotiated agreement the practical arrangements for informing and consulting employees. These agreements, and agreements existing on the date laid down in Article 11, as well as any subsequent renewals of such agreements, may establish, while respecting the principles set out in Article 1 and subject to conditions and limitations laid down by the Member States, provisions which are different from those referred to in Article 4.Article 6Confidential information1. Member States shall provide that, within the conditions and limits laid down by national legislation, the employees' representatives, and any experts who assist them, are not authorised to reveal to employees or to third parties, any information which, in the legitimate interest of the undertaking or establishment, has expressly been provided to them in confidence. This obligation shall continue to apply, wherever the said representatives or experts are, even after expiry of their terms of office. However, a Member State may authorise the employees' representatives and anyone assisting them to pass on confidential information to employees and to third parties bound by an obligation of confidentiality.2. Member States shall provide, in specific cases and within the conditions and limits laid down by national legislation, that the employer is not obliged to communicate information or undertake consultation when the nature of that information or consultation is such that, according to objective criteria, it would seriously harm the functioning of the undertaking or establishment or would be prejudicial to it.3. Without prejudice to existing national procedures, Member States shall provide for administrative or judicial review procedures for the case where the employer requires confidentiality or does not provide the information in accordance with paragraphs 1 and 2. They may also provide for procedures intended to safeguard the confidentiality of the information in question.Article 7Protection of employees' representativesMember States shall ensure that employees' representatives, when carrying out their functions, enjoy adequate protection and guarantees to enable them to perform properly the duties which have been assigned to them.Article 8Protection of rights1. Member States shall provide for appropriate measures in the event of non-compliance with this Directive by the employer or the employees' representatives. In particular, they shall ensure that adequate administrative or judicial procedures are available to enable the obligations deriving from this Directive to be enforced.2. Member States shall provide for adequate sanctions to be applicable in the event of infringement of this Directive by the employer or the employees' representatives. These sanctions must be effective, proportionate and dissuasive.Article 9Link between this Directive and other Community and national provisions1. This Directive shall be without prejudice to the specific information and consultation procedures set out in Article 2 of Directive 98/59/EC and Article 7 of Directive 2001/23/EC.2. This Directive shall be without prejudice to provisions adopted in accordance with Directives 94/45/EC and 97/74/EC.3. This Directive shall be without prejudice to other rights to information, consultation and participation under national law.4. Implementation of this Directive shall not be sufficient grounds for any regression in relation to the situation which already prevails in each Member State and in relation to the general level of protection of workers in the areas to which it applies.Article 10Transitional provisionsNotwithstanding Article 3, a Member State in which there is, at the date of entry into force of this Directive, no general, permanent and statutory system of information and consultation of employees, nor a general, permanent and statutory system of employee representation at the workplace allowing employees to be represented for that purpose, may limit the application of the national provisions implementing this Directive to:(a) undertakings employing at least 150 employees or establishments employing at least 100 employees until 23 March 2007, and(b) undertakings employing at least 100 employees or establishments employing at least 50 employees during the year following the date in point (a).Article 11Transposition1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive not later than 23 March 2005 or shall ensure that management and labour introduce by that date the required provisions by way of agreement, the Member States being obliged to take all necessary steps enabling them to guarantee the results imposed by this Directive at all times. They shall forthwith inform the Commission thereof.2. Where Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.Article 12Review by the CommissionNot later than 23 March 2007, the Commission shall, in consultation with the Member States and the social partners at Community level, review the application of this Directive with a view to proposing any necessary amendments.Article 13Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 14AddressesThis Directive is addressed to the Member States.Done at Brussels, 11 March 2002.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentJ. Piqué i Camps(1) OJ C 2, 5.1.1999, p. 3.(2) OJ C 258, 10.9.1999, p. 24.(3) OJ C 144, 16.5.2001, p. 58.(4) Opinion of the European Parliament of 14 April 1999 (OJ C 219, 30.7.1999, p. 223), confirmed on 16 September 1999 (OJ C 54, 25.2.2000, p. 55), Council Common Position of 27 July 2001 (OJ C 307, 31.10.2001, p. 16) and Decision of the European Parliament of 23 October 2001 (not yet published in the Official Journal). Decision of the European Parliament of 5 February 2002 and Decision of the Council of 18 February 2002.(5) OJ L 225, 12.8.1998, p. 16.(6) OJ L 82, 22.3.2001, p. 16.(7) OJ L 254, 30.9.1994, p. 64. Directive as amended by Directive 97/74/EC (OJ L 10, 16.1.1998, p. 22).Joint declaration of the European Parliament, the Council and the Commissionon employee representation"With regard to employee representation, the European Parliament, the Council and the Commission recall the judgements of the European Court of Justice of 8 June 1994 in Cases C-382/92 (Safeguarding of employees rights in the event of transfers of undertakings) and C-383/92 (Collective redundancies)."