ISSN 1977-0677 |
||
Official Journal of the European Union |
L 67 |
|
English edition |
Legislation |
Volume 63 |
|
|
|
(1) Text with EEA relevance. |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/1 |
COMMISSION REGULATION (EU) 2020/354
of 4 March 2020
establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC
(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 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (1), and in particular Article 10(5) thereof,
Whereas:
(1) |
The placing on the market and use of feed is regulated by Regulation (EC) No 767/2009. In accordance with Article 9 of that Regulation, feed intended for particular nutritional purposes may only be marketed if its intended use is included in a list of intended uses established in accordance with Article 10 of the said Regulation. |
(2) |
Commission Directive 2008/38/EC (2) established a list of intended uses of animal feedingstuffs for particular nutritional purposes. |
(3) |
Part A of Annex I to Directive 2008/38/EC established the general provisions for feed intended for particular nutritional purposes. Considering scientific and technological developments and the labelling requirements established by Regulation (EC) No 767/2009, those general provisions are to be reviewed. |
(4) |
Articles 11 to 17 of Regulation (EC) No 767/2009 established new principles and rules for the placing on the market of feed, including labelling. As a consequence, several entries in the list of intended uses of feed intended for particular nutritional purposes contained in Part B of Annex I to Directive 2008/38/EC became outdated, partially because of poor and overly general descriptions in the column ‘Essential nutritional characteristics’. For such entries, it has been very difficult for the control authorities to verify compliance with the provisions of Regulation (EC) No 767/2009, including whether the specific composition of the feed concerned fulfils the respective particular intended nutritional purpose. |
(5) |
In accordance with Article 10 of Regulation (EC) No 767/2009, the Commission received a number of applications to amend and change the conditions associated with several intended uses of feed for particular nutritional purposes, which had become outdated. Outdated entries for which no application has been submitted or for which the application was withdrawn should be removed. |
(6) |
As regards other intended uses of feed intended for particular nutritional purposes listed in Part B of Annex I to Directive 2008/38/EC, amendments are necessary to the provisions concerning the essential nutritional characteristics and the labelling declarations in order to adapt them to the scientific and technological developments and to improve the enforceability and clarity of the provisions. |
(7) |
Furthermore, the Commission received, in accordance with Article 10 of Regulation (EC) No 767/2009, applications to add the particular nutritional purposes ‘support of energy metabolism and of the muscle function in the case of rhabdomyolosis’ and ‘support in stressful situations, which will lead to the reduction of associated behaviour’ to the list of intended uses of feed intended for particular nutritional purposes. |
(8) |
The Commission made all applications, including the dossiers, available to the Member States. |
(9) |
Following the assessment of the dossiers included in those applications, the Standing Committee on Plants, Animals, Food and Feed (‘the Committee’) acknowledged that the specific composition of the feed concerned fulfils the respective particular intended nutritional purpose and that it has no adverse effects on animal health, human health, the environment or animal welfare. |
(10) |
Based on the above considerations, the list of intended uses of feed for particular nutritional purposes should be updated. |
(11) |
Since safety reasons do not require the immediate application of the new general provisions and of the updated list of intended uses of feed for particular nutritional purposes, it is appropriate to provide for transitional measures in order to avoid unnecessary disruption of commercial practices and to not create unnecessary administrative burden on the operators. |
(12) |
In the interests of clarity and rationality, Directive 2008/38/EC should be repealed and replaced by a Regulation, which does not contain elements that would require transpositions by the Member States into national law. The last amendments to that Directive had already been successively brought through Regulations due to the absence of need of transposition into national law of the provisions concerned. In addition, the general requirements for the placing on the market and use of feed intended for particular nutritional purposes are provided for in Regulation (EC) No 767/2009. |
(13) |
In order to enable Member States to make the necessary adjustments, an adequate period should be allowed before this Regulation becomes applicable. |
(14) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee, |
HAS ADOPTED THIS REGULATION:
Article 1
Feed intended for particular nutritional purposes within the meaning of Regulation (EC) No 767/2009 may be marketed only if:
— |
the general provisions for feed intended for particular nutritional purposes laid down in Part A of the Annex to this Regulation are complied with, and |
— |
its intended use is included in Part B of the Annex to this Regulation and the provisions of the respective entry are complied with. |
Article 2
By way of derogation from Article 1, feed intended for particular nutritional purposes which complies with the provisions of Directive 2008/38/EC may continue to be placed on the market, provided that an application for an intended use included therein has been submitted to the Commission in accordance with Article 10 of Regulation (EC) No 767/2009 before 25 March 2021 and until the Commission decides on the respective application.
Article 3
Feed intended for particular nutritional purposes which has been labelled before 25 March 2022 in accordance with the rules applicable before 25 March 2020 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 4
Directive 2008/38/EC is repealed.
Article 5
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 25 December 2020.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 March 2020.
For the Commission
The President
Ursula VON DER LEYEN
(2) Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (OJ L 62, 6.3.2008, p. 9).
ANNEX
PART A
General provisions for feed for particular nutritional purposes
1. |
Where there is more than one group of essential nutritional characteristics indicated in column 2 of Part B, denoted by ‘and/or’, for the same particular nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the particular nutritional purpose defined in column 1 of Part B. For each option the corresponding labelling declarations are given in column 4 of Part B. |
2. |
Where an essential nutritional characteristic mentioned in column 2 of Part B is quantitatively indicated, the provisions of Article 17(2) of Regulation (EC) No 767/2009 and the permitted tolerances as established in Annex IV to that Regulation shall apply. If that Annex does not establish a tolerance for the respective labelling particular, a technical deviation of +/- 15 % shall be permitted. |
3. |
Where a feed additive is mentioned in column 2 or column 4 of Part B, the authorisation provisions for feed additive(s) in accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council (1) are applicable and their use shall comply with the specified essential nutritional characteristic. |
4. |
Where the declaration of a substance, also authorised as a feed additive, is required in column 4 of Part B and is accompanied by the expression ‘total’, the total content of the substance shall be labelled under the heading ‘analytical constituents’. |
5. |
The declarations to be given in accordance with column 4 of Part B shall be quantitative without prejudice to Directive 2004/48/EC of the European Parliament and of the Council (2). |
6. |
The recommended period of use indicated in column 5 of Part B indicates a range within which the nutritional purpose should normally be achieved. Manufacturers can refer to more precise periods of use, within the fixed limits. |
7. |
Where a feed intended for particular nutritional purposes is intended to meet more than one particular nutritional purpose, it shall comply with each respective entry in Part B. |
8. |
In the case of complementary feed intended for particular nutritional purposes, guidance on the balance of the daily ration must be provided in the instructions for proper use. |
9. |
When a feed intended for particular nutritional purposes is with an appropriate mode of use intended for individual oral administration via a bolus, this shall be established in the column ‘other provisions’ of the respective feed. Such feed shall exclusively contain, including a potential coating, feed materials and feed additives, unless detailed otherwise in the respective entry. It is recommended that feed intended for individual oral administration is administered by a veterinarian or any other competent person. |
10. |
When a feed intended for particular nutritional purposes is placed on the market in the form of a bolus, being a feed material or complementary feed intended for individual oral administration with retarding release, i.e. more than 24 hours, of the compounds, the labelling of such feed shall, if applicable, mention for each feed additive for which a maximum content in complete feed is fixed the maximum period of continuous release of the bolus and the daily release rate. The feed business operator which is placing a bolus on the market shall have the proof that the daily available feed additive level in the digestive tract will not exceed, if applicable, the maximum content of the additive established per kg complete feed during the whole feeding period (retarding release effect). Such proof should be based on a peer reviewed methodology or in-house analysis. |
11. |
In case of intended uses for which in column 2 a concentration of certain feed additives higher than 100 times the relevant fixed maximum content in complete feed is allowed for complementary feed, the concentration of those feed additives shall not be higher than 500 times the relevant fixed maximum content in complete feed, except in the case of boluses as referred to in point 10. The incorporation of such complementary feed into the animal`s diet shall ensure that the uptake of the animal complies with the fixed maximum content in complete feed. |
PART B
List of intended uses
Entry number |
Particular nutritional purpose |
Essential nutritional characteristics (GP1) |
Species or category of animal |
Labelling declarations (GP2) |
Recommended length of time |
Other provisions |
||||||||||||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||||||||||||||||||||||||||||
10 |
Support of renal function in case of chronic renal insufficiency (3) |
High quality proteins and phosphorus ≤ 5 g/kg complete feed with a moisture content of 12 % (4) and crude protein ≤ 220 g/kg complete feed with a moisture content of 12 % (4) |
Dogs |
|
Initially up to 6 months (5) |
|
||||||||||||||||||||||||||||||||
Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate |
Adult dogs |
|
Initially up to 6 months (5) |
|
||||||||||||||||||||||||||||||||||
High quality proteins and phosphorus ≤ 6,5 g/kg complete feed with a moisture content of 12 % (4) and crude protein ≤ 320 g/kg complete feed with a moisture content of 12 % (4) |
Cats |
|
Initially up to 6 months (5) |
|
||||||||||||||||||||||||||||||||||
Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate |
Adult cats |
|
Initially up to 6 months (5) |
|
||||||||||||||||||||||||||||||||||
High density of energy with more than 8,8 MJ/kg feed with a moisture content of 12 %. Highly digestible and highly palatable sources of starch. Restricted protein level: ≤ 106 g crude protein/kg feed with a moisture content of 12 %. Level of sodium: 2 g/100 kg BW per day. High level of eicosapentaenoic acid and docosahexaenoic sum ≥ 0,2 g per kg BW0,75 per day |
Equines |
|
Initially up to six months. Long term or until resolution of the issue |
|
||||||||||||||||||||||||||||||||||
11 |
Reduction of oxalate stones formation |
Low level of calcium, low level of vitamin D, and urine alkalising properties |
Dogs and cats |
|
Up to 6 months |
Indicate on the labelling: ‘It is recommended that a veterinarian’s opinion be sought before use.’ |
||||||||||||||||||||||||||||||||
12 |
Regulation of glucose supply (Diabetes mellitus) |
Total sugars (mono- and disaccharides) ≤ 62 g/kg complete feed with a moisture of 12 % (4) |
Dogs and cats |
|
Initially up to 6 months |
|
||||||||||||||||||||||||||||||||
13 |
Reduction of ingredient and nutrient intolerances (6) |
Selected and limited number of protein source(s) And/or hydrolysed protein source(s) And/or selected carbohydrate source(s) |
Dogs and cats |
|
3 to 8 weeks: if signs of intolerance disappear this feed can be used initially up to one year. |
|
||||||||||||||||||||||||||||||||
14 |
Reduction of cystine stones formation |
Urine alkalinising properties and crude protein ≤ 160 g/kg complete feed with a moisture content of 12 % (4) Or Proteins selected for a limited cystine and cysteine content (e.g. casein, pea protein, soy protein) and crude protein ≤ 220 g/kg complete feed with a moisture content of 12 % (4) |
Dogs |
|
Initially up to 6 month |
‘Water should be available at all times’
|
||||||||||||||||||||||||||||||||
15 |
Nutritional restoration, convalescence (7) |
Highly digestible ingredients with energy density ≥ 3 520 kcal and crude protein ≥ 250 g per kg of complete feed with a moisture level 12 % (4) |
Dogs |
|
Until restoration is achieved |
|
||||||||||||||||||||||||||||||||
Highly digestible ingredients with energy density ≥ 3520 kcal and crude protein ≥ 270 g per kg of complete feed with a moisture level 12 % (4) |
Cats |
|||||||||||||||||||||||||||||||||||||
16 |
Reduction of urate stones formation |
Crude protein ≤ 130 g/kg complete feed with a moisture level of 12 % (4) Or Crude protein ≤ 220 g/kg complete feed with a moisture level of 12 % (4) and selected protein sources |
Dogs |
|
Up to 6 months, but lifetime use in case of irreversible disturbance of uric acid metabolism |
|
||||||||||||||||||||||||||||||||
Crude protein ≤ 317 g/kg complete feed with a moisture content of 12 % (4) |
Cats |
|
||||||||||||||||||||||||||||||||||||
17 |
Dissolution of struvite stones (8) |
Urine undersaturating (9) properties for struvite And/or Urine acidifying properties (10) And Magnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 % (4) |
Dogs and cats |
|
5 to 12 weeks |
|
||||||||||||||||||||||||||||||||
18 |
Reduction of struvite stone recurrence (8) |
Complete feed with urine undersaturating (9) or metastabilising properties (11) for struvite And/or Diet with urine acidifying properties (10) And Magnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 % (4) |
Dogs and cats |
|
Initially up to 6 month |
|
||||||||||||||||||||||||||||||||
19 |
Compensation for maldigestion (12) |
Highly digestible diet: Apparent digestibility of
Or
|
Dogs and cats |
|
Initially up to 12 weeks and lifetime in the case of chronic pancreatic insufficiency |
|
||||||||||||||||||||||||||||||||
20 |
Reduction of intestinal absorptive disorders |
Highly digestible diet: Apparent digestibility of
Or
And Sodium ≥ 1,8 g per kg of complete feed with a moisture level 12 % (4) And Potassium ≥ 5 g per kg of complete feed with a moisture level 12 % (4) |
Dogs and cats |
|
Up to 12 weeks |
Indicate on the labelling:
|
||||||||||||||||||||||||||||||||
21 |
Reduction of acute intestinal absorptive disorders |
Increased level of electrolytes:
And Highly digestible carbohydrates:
|
Dogs and cats |
|
1 – 7 days |
|
||||||||||||||||||||||||||||||||
22 |
Support of lipid metabolism in the case of hyperlipidaemia |
Fat (13) ≤ 110 g/kg complete feed with a moisture content of 12 % (14) |
Dogs and cats |
|
Initially up to 2 months |
|
||||||||||||||||||||||||||||||||
23 |
Support of liver function in the case of chronic liver insufficiency |
Moderate level of protein: Crude protein ≤ 279 g/kg complete feed with a moisture content of 12 % (4) for dogs Crude protein ≤ 370 g/kg complete feed with a moisture content of 12 % (4) for cats And Selected protein sources And Recommended dietary protein digestibility ≥ 85 % |
Dogs and cats |
|
Initially up to 4 months |
|
||||||||||||||||||||||||||||||||
Low level of protein but of high quality and highly digestible carbohydrates |
Equines |
|
Initially up to six months |
|
||||||||||||||||||||||||||||||||||
24 |
Support of heart function in the case of chronic cardiac insufficiency |
Restricted level of sodium: Sodium ≤ 2,6 g per kg complete feed with a moisture content of 12 % (4) |
Dogs and cats |
|
Initially up to 6 months |
|
||||||||||||||||||||||||||||||||
25 |
Reduction of excessive body weight |
Metabolizable Energy < 3060 kcal/kg complete feed with moisture content of 12 % (15) Or Metabolizable Energy < 560 kcal/kg complete feed with moisture content of 85 % (15) |
Dogs |
|
Until target body weight is achieved and after if required to maintain target bodyweight |
|
||||||||||||||||||||||||||||||||
Metabolizable Energy < 3190 kcal per kg complete feed with moisture content of 12 % (15) Or Metabolizable Energy < 580 kcal per kg complete feed with moisture content of 85 % (15) |
Cats |
|||||||||||||||||||||||||||||||||||||
26 |
Support of skin function in the case of dermatosis and excessive loss of hair |
Linoleic acid ≥ 12,3 g per kg and sum of eicosapentaenoic acid and docosahexaenoic acid ≥ 2,9 g per kg of complete feed with a moisture content of 12 % (4) |
Dogs and cats |
|
Initially up to 2 months |
Indicate on the labelling:
|
||||||||||||||||||||||||||||||||
Linoleic acid ≥ 18,5 g per kg and sum of eicosapentaenoic acid and docosahexaenoic acid ≥ 0,39 g per kg of complete feed with a moisture content of 12 % (4) |
Dogs |
|||||||||||||||||||||||||||||||||||||
Linoleic acid ≥ 18,5 g per kg and sum of eicosapentaenoic acid and docosahexaenoic acid ≥ 0,09 g per kg of complete feed with a moisture content of 12 % (4) |
Cats |
|||||||||||||||||||||||||||||||||||||
27 |
Support of the metabolism of joints in the case of osteoarthritis |
Total omega-3 fatty acids ≥ 29 g per kg and eicosapentaenoic acid ≥ 3,3 g per kg complete feed with a moisture content of 12 % (4) And Adequate levels of vitamin E |
Dogs |
|
Initially up to 3 months |
Indicate on the labelling:
|
||||||||||||||||||||||||||||||||
Total omega-3 fatty acids ≥ 10,6 g per kg complete feed with a moisture content of 12 % (4) and docosahexaenoic acid ≥ 2,5 g per kg complete feed with a moisture content of 12 % (4) And Increased levels of methionine and manganese Adequate levels of vitamin E. |
Cats |
|
|
|||||||||||||||||||||||||||||||||||
28 |
Reduction of copper in the liver |
Restricted level of copper: copper ≤ 8,8 mg per kg complete feed with a moisture content of 12 % (4) |
Dogs |
Copper (total) |
Initially up to 6 months |
|
||||||||||||||||||||||||||||||||
29 |
Reduction of iodine levels in feed in case of hyperthyroidism |
Restricted level of iodine: iodine ≤ 0,26 mg per kg complete feed with a moisture content of 12 % (4) |
Cats |
Iodine (total) |
Initially up to 3 months |
|
||||||||||||||||||||||||||||||||
30 |
Support in stressful situations, which will lead to the reduction of associated behaviour |
1-3 g trypsin-hydrolysed bovine casein per kg complete feed with a moisture content of 12 % (4) |
Dogs |
Trypsin-hydrolysed bovine casein |
Initially up to 2 months |
|
||||||||||||||||||||||||||||||||
50 |
Support the preparation for oestrus and reproduction |
Or
The complementary feed may contain selenium, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Mammals |
Names and total amounts of each added trace element and vitamin |
|
|
||||||||||||||||||||||||||||||||
|
Or
The complementary feed may contain selenium, zinc, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Birds |
Names and total amounts of each added trace element and vitamin |
|
||||||||||||||||||||||||||||||||||
51 |
Support the regeneration of hooves, trotters and skin |
High level of zinc. The complementary feed may contain zinc in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Horses, ruminants and pigs |
|
Up to 8 weeks |
|
||||||||||||||||||||||||||||||||
52 |
Support for nutritional imbalances in dietary transition |
Minimum supply via the dietetic feed of:
And/or
And/or
And/or
And/or
And/or
The complementary feed may contain selenium, zinc, copper, vitamin A and vitamin D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Ruminants Pigs Rabbits Poultry |
Name and total amount of the nutritional additives, if appropriate |
2 to 15 days |
|
||||||||||||||||||||||||||||||||
53 |
Support weaning |
Minimum supply via the dietetic feed of:
And/or
And/or
And/or
And/or
And/or
And/or
And/or
The complementary feed may contain selenium, zinc, copper, iodine, manganese, vitamin A and vitamin D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Mammals |
Name and total amount of the nutritional additives, if appropriate |
Up to 4 weeks around weaning |
|
||||||||||||||||||||||||||||||||
54 |
Support the regeneration of the skin and appendages |
And
and/or vitamin B6 and/or vitamin E and/or vitamin A and/or methionine and/or cystine and/or minimum supply of 0,4 mg biotin/kg complete feed with a moisture content of 12 % for ruminants. The complementary feed may contain zinc, copper, iodine, selenium and vitamin A in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Mammals and poultry |
Name and total amount of the nutritional additives, if appropriate |
|
|
||||||||||||||||||||||||||||||||
55 |
Stabilisation of water and electrolyte balance to support the physiological digestion |
|
Calves, pigs, lambs, kids and foals |
|
1 to 7 days |
|
||||||||||||||||||||||||||||||||
56 |
Reduction of the risk of tetany (hypomagnesaemia) |
High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassium |
Ruminants |
|
3 to 10 weeks during periods of fast grass growth |
|
||||||||||||||||||||||||||||||||
57 |
Reduction of the risk of acidosis |
Low level of easily fermentable carbohydrates and high buffering capacity |
Ruminants |
|
up to 2 months (17) |
|
||||||||||||||||||||||||||||||||
58 |
Reduction of the risk of urinary calculi |
Low level of phosphorus, magnesium, and urine acidifying properties |
Ruminants |
|
Up to 6 weeks |
|
||||||||||||||||||||||||||||||||
59 |
Long-term supply of grazing animals with trace elements and/or vitamins |
High level of
And/or
The complementary feed may contain feed additives in a concentration higher than 100 times the relevant fixed maximum content in complete feed |
Ruminants with a functional rumen |
|
Up to 12 months |
|
||||||||||||||||||||||||||||||||
60 |
Reduction of the risk of milk fever and subclinical hypocalcaemia |
Low cations/anions ratio For the total ration:
Or |
Dairy cows |
|
From 3 weeks before calving until calving |
Indicate in the instructions for proper use: ‘Stop feeding after calving’ |
||||||||||||||||||||||||||||||||
Zeolite (sodium aluminium silicate): 250 – 500 g/day |
|
Sodium aluminium silicate |
From 3 weeks before calving until calving |
Indicate in the instructions for proper use:
|
||||||||||||||||||||||||||||||||||
Or Supply of rumen protected feed materials rich in phytic acid (> 6 %) and having a calcium content < 0,2 %, to achieve a minimum of 28 g and a maximum of 32 g available calcium per cow per day. Or |
|
|
From 4 weeks before calving until calving |
Indicate in the instructions for proper use: ‘Stop feeding after calving’ |
||||||||||||||||||||||||||||||||||
High level of calcium in the form of highly available sources of calcium: calcium chloride and/or calcium sulfate and/or dicalcium phosphate and/or calcium carbonate and/or calcium propionate and/or calcium formate. and/or ‘any other calcium source having a similar effect’ Calcium provided by one or a combination of these sources with a minimum of 50 g per cow per day Or |
|
|
From first signs of parturition to two days Subsequent to parturition |
|
||||||||||||||||||||||||||||||||||
Calcium pidolate in a minimum of 5,5 g per cow per day Or |
|
|
From first signs of parturition to two days subsequent to parturition |
|
||||||||||||||||||||||||||||||||||
Waxy-leaf nightshade meal allowing a daily release of 38 – 46 μg 1,25 dihydroxycholecalciferol-glycoside per day |
|
|
From two days before calving or first signs of parturition to 10 days subsequent to parturition |
|
||||||||||||||||||||||||||||||||||
61 |
Reduction of the risk of ketosis (20) |
Or
Or
|
Dairy cows, ewes and goats |
|
Between three weeks before and six weeks after calving for dairy cows Between six weeks before and three weeks after parturition for ewes and goats |
|
||||||||||||||||||||||||||||||||
62 |
Reduction of stress reactions |
And/or
|
Pigs |
|
1 to 7 days |
Guidance shall be provided on the situation in which the use of this feed is appropriate. |
||||||||||||||||||||||||||||||||
63 |
Reduction of the risk of constipation |
Ingredients stimulating intestinal passage |
Sows |
Ingredients stimulating intestinal passage |
10 to 14 days before and 10 to 14 days after farrowing |
|
||||||||||||||||||||||||||||||||
64 |
Compensation for insufficient iron availability after birth |
High level of iron compounds authorised under the functional group ‘compounds of trace elements’ of the category ‘nutritional additives’ as referred to in Annex I to Regulation (EC) No 1831/2003. The complementary feed may contain iron in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Suckling piglets and calves |
Iron (total) |
After birth up to 3 weeks |
The instructions for proper use shall ensure that the legal maximum contents of iron for complete feed are respected. |
||||||||||||||||||||||||||||||||
65 |
Compensation for malabsorption |
Low level of saturated fatty acids and high level of fat soluble vitamins |
Poultry excluding geese and pigeons |
|
During the first 2 weeks after hatching |
|
||||||||||||||||||||||||||||||||
66 |
Reduction of the risk of fatty liver syndrome |
Low energy and high proportion of metabolisable energy from lipids with high level of polyunsaturated fatty acids |
Laying hens |
|
Up to 12 weeks |
|
||||||||||||||||||||||||||||||||
67 |
Support the preparation for and recovery from sport effort |
High level of selenium and a minimum content of 50 mg vitamin E per kg complete feed with moisture content of 12 %. The complementary feed may contain compounds of selenium in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Equidae |
|
Up to 8 weeks before sport effort – Up to 4 weeks after sport effort |
The instructions for proper use for the feed shall ensure that the legal maximum contents of selenium for complete feed are respected. |
||||||||||||||||||||||||||||||||
68 |
Compensation of electrolyte loss in the cases of heavy sweating |
Must contain sodium chloride and should contain potassium chloride. Low levels of Magnesium, Calcium and Phosphorus The inclusion of other electrolyte salts is optional. |
Equines |
|
One to three days after heavy sweating. |
|
||||||||||||||||||||||||||||||||
69 |
Support of energy metabolism and of the muscle function in the case of rhabdomyolosis |
Starch and sugar not more than 20 % of available energy. Crude fat more than 20 % of available energy Minimum of 350 IU Vitamin E/kg complete feed with a moisture content of 12 % |
Equines |
|
Initially for a minimum of 3 months |
|
||||||||||||||||||||||||||||||||
70 |
Compensation for chronic digestive disorders of large intestine |
|
Equines |
|
Long term or until resolution of the issue |
|
||||||||||||||||||||||||||||||||
71 |
Compensation for chronic insufficiency of small intestine function |
|
Equines |
|
Long term or until resolution of the issue |
|
||||||||||||||||||||||||||||||||
72 |
Stabilisation of the physiological digestion |
Feed additives of the functional group ‘Gut flora stabiliser’ as referred to in Annex I to Regulation (EC) No 1831/2003 or, pending the re-authorisation procedure as referred to in Article 10 of Regulation (EC) No 1831/2003, feed additives of the group ‘micro-organisms’ |
Animal species for which the gut flora stabiliser or micro-organism is authorised |
Name and added amount of the gut flora stabiliser or micro- organism |
Up to 4 weeks |
|
(1) Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).
(2) Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45).
(GP1) For the control of the quantitative indications, the tolerances as established in Annex IV of Regulation (EC) No 767/2009 apply.
(GP2) These labelling declarations apply in addition to the general labelling requirements laid down in Regulation (EC) No 767/2009
(3) If appropriate the manufacturer may also recommend use for temporary renal insufficiency.
(4) based on a diet with a dry matter energy density of 4000 kcal Metabolisable Energy/kg calculated using the equation described in the FEDIAF Nutritional Guidelines (http://www.fediaf.org/self-regulation/nutrition.html). The values shall be adapted if the energy density deviates from the 4000 kcal Metabolisable Energy/kg.
(5) If the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.
(6) In the case of feed for a particular intolerance, reference to the specific intolerance can replace ‘ingredient and nutrient’
(7) For cats a reference to ‘Feline hepatic lipidosis’ may be added
(8) For cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome – FUS’ may be added.
(9) Undersaturating properties: urine associated with crystal and stone dissolution properties and/or properties of prevention of crystal precipitation and growth.
(10) Urine pH ≤ 6,5.
(11) Metastabilising properties: urine associated with properties of prevention of crystal precipitation.
(12) ‘exocrine pancreatic insufficiency’ may be added.
(13) The minimum recommendations according to the FEDIAF Nutritional Guidelines (http://www.fediaf.org/self-regulation/nutrition.html) for all essential fatty acids shall be met in the daily ration.
(14) based on a diet with a dry matter energy density of 3500 kcal Metabolisable Energy/kg calculated using the equation described in the FEDIAF Nutritional Guidelines
(http://www.fediaf.org/self-regulation/nutrition.html). The values shall be adapted if the energy density deviates from the 3500 kcal Metabolisable Energy/kg.
(15) Metabolisable Energy/kg calculated using the equation described in the FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.
(16) FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.
(17) In the case of feed for dairy cows: ‘maximum two months from the start of lactation’.
(18) Indicate the category of ruminants concerned.
(19) DCAD (mEq/kg dry matter) = (Na + K) – (Cl + S).
(20) The term ‘ketosis’ may be replaced by ‘acetonaemia’ and the person responsible for the labelling may also recommend the use for ketosis recuperation.
(21) Calculated by the Strong Ion Difference method (SID-Value): SID is the difference between the sums of concentrations of the strong cations and strong anions; [SID] = [mmol Na+/l] + [mmol K+/l] + [mmol Ca++/l] + [mmol Mg++/l] – [mmol Cl-/l] – [mmol Other Strong Anions/l].
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/28 |
COMMISSION REGULATION (EU) 2020/355
of 26 February 2020
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of polyglycerol polyricinoleate (E 476) in liquid vegetable oil emulsions
(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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) thereof,
Whereas:
(1) |
Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use. |
(2) |
That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application. |
(3) |
Pursuant to Annex II to Regulation (EC) No 1333/2008 polyglycerol polyricinoleate (E 476) is an already authorised food additive in food category 02.2.2 ‘Other fat and oil emulsions including spreads as defined by Regulation (EC) No 1234/2007 and liquid emulsions’ (at a maximum level of 4 000 mg/kg), but only for spreadable fats as defined in Article 115 of Council Regulation (EC) No 1234/2007 (3) and Annex XV thereto, having a fat content of 41 % or less and similar spreadable products with a fat content of less than 10 % fat. Regulation (EC) No 1234/2007 has been later repealed by Regulation (EU) No 1308/2013 of the European Parliament and of the Council (4). |
(4) |
On 27 May 2017, an application was submitted for the authorisation of the use of polyglycerol polyricinoleate (E 476) as an emulsifier in liquid vegetable oil emulsions for sale to the final consumer, having a fat content of 70 % or less. The application was subsequently made available to the Member States by the Commission pursuant to Article 4 of Regulation (EC) No 1331/2008. |
(5) |
Polyglycerol polyricinoleate (E 476) is a water-in-oil emulsifier capable of forming very stable oil emulsions with high water content. In studies carried out by the applicant, comparing the effectiveness of different emulsifiers for the production of liquid vegetable oil emulsions with reduced fat content, polyglycerol polyricinoleate (E 476) gave the best results both in terms of physical as well as organoleptic properties of the obtained product. The emulsion can be used in the same way as vegetable oils for the preparation of cold and hot dishes. However, the emulsion has a lower fat content (70 % or less), and therefore a lower caloric content than the vegetable oil used for its production. The level of use of polyglycerol polyricinoleate (E 476) needed to achieve the intended technological function was 4 000 mg/kg. |
(6) |
On 24 March 2017, the European Food Safety Authority (‘the Authority’) delivered a scientific opinion on the re-evaluation of polyglycerol polyricinoleate (E 476) (5) and established an acceptable daily intake (ADI) of 25 mg polyglycerol polyricinoleate/kg body weight/day. Considering that the exposure estimates did not exceed the ADI, the Authority concluded that polyglycerol polyricinoleate (E 476) as a food additive would not be of safety concern, if used at the permitted or reported use and use levels |
(7) |
In the application the applicant estimated the exposure by using the Food Additives Intake Model (6) developed by the Authority. The estimates provided indicate that the additional use of polyglycerol polyricinoleate (E 476) at the maximum level of 4 000 mg/kg in liquid vegetable oil emulsions having a fat content of 70 % or less, is not of safety concern, since it would not result in a total exposure to this substance exceeding the established ADI. |
(8) |
Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. |
(9) |
Since the extended use of polyglycerol polyricinoleate (E 476) in food category 02.2.2 is not of safety concern, it requires an update of the Union list, which is not liable to have an effect on human health and hence it is not necessary to seek the opinion of the Authority. |
(10) |
Therefore, it is appropriate to authorise the use of polyglycerol polyricinolate (E 476) as an emulsifier in liquid vegetable oil emulsions for sale to the final consumer, having a fat content of 70 % or less, in food category 02.2.2 ‘Other fat and oil emulsions including spreads as defined by Regulation (EC) No 1234/2007 and liquid emulsions’. |
(11) |
Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly. |
(12) |
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
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
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, 26 February 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 354, 31.12.2008, p. 16.
(2) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
(3) 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) (OJ L 299, 16.11.2007, p. 1).
(4) 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 (OJ L 347, 20.12.2013, p. 671).
(5) EFSA Journal 2017;15(3):4743.
(6) https://www.efsa.europa.eu/en/applications/foodingredients/tools
ANNEX
In Part E of Annex II to Regulation (EC) No 1333/2008, in food category 02.2.2 ‘Other fat and oil emulsions including spreads as defined by Regulation (EC) No 1234/2007 and liquid emulsions’, the entry for polyglycerol polyricinoleate (E 476) is replaced by the following:
|
‘E 476 |
Polyglycerol polyricinoleate |
4000 |
|
only spreadable fats as defined in Articles 75(1)(h) and 78(1)(f) and in Part VII and Appendix II of Annex VII to Regulation (EC) No 1308/2013 (*1), having a fat content of 41 % or less and similar spreadable products with a fat content of less than 10 % fat; liquid vegetable oil emulsions for sale to the final consumer, having a fat content of 70 % or less |
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/31 |
COMMISSION REGULATION (EU) 2020/356
of 4 March 2020
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of polysorbates (E 432-436) in carbonated beverages
(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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) thereof,
Whereas:
(1) |
Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use. |
(2) |
That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application. |
(3) |
Pursuant to Annex II to Regulation (EC) No 1333/2008, polyoxyethylene sorbitan tristearate (polysorbate 65) (E 436) is currently authorised for use as a food additive in the group ‘polysorbates’ (E 432-436) in a wide variety of foods at maximum levels ranging between 500 and 10 000 mg/kg and quantum satis in food supplements. |
(4) |
On 4 July 2018, an application was submitted for the authorisation of the use of polysorbate 65 (E 436) as an anti-foaming agent in several types of beverages. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
(5) |
It results from the application that, the proposed use of polysorbate 65 (E 436) is required at the maximum level of 10 mg/kg for containment and inhibition of foam during the manufacture of carbonated beverages by forming a layer around bubbles and stabilising larger bubbles preventing them to coalesce and break. The application shows that, the inhibition of foam is needed to efficiently operate the production equipment, to reduce product waste, to maintain a safe workplace, and to keep facilities clean and in a hygienic state. |
(6) |
Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. |
(7) |
The safety of polysorbates (E 432-436) used as food additives was re-evaluated by the Authority in 2015 (3). The Authority concluded that the exposure estimates did not exceed the acceptable daily intake (ADI) of 25 mg/kg body weight/day in the refined non-brand-loyal scenario for all age groups at both the mean exposure level and the high level; although for toddlers at the highest level they were very close to the ADI. The Authority noted that more data were needed to decrease uncertainties in the refined exposure assessment scenario used since no reported uses had been obtained for three food categories and that other dietary sources of exposure to polysorbates could not be considered in the opinion. |
(8) |
In the application the applicant estimated the exposure by using the Food Additives Intake Model (4) developed by the Authority. The estimates provided indicate that the additional exposure due to the requested extension of use is negligible (below 1 % of the ADI). |
(9) |
The extended use of polysorbate 65 (E 436) at the maximum level of 10 mg/kg in the food categories 14.1.4 ‘Flavoured drinks’, 14.2.3 ‘Cider and perry’, 14.2.4 ‘Fruit wine and made wine’ and 14.2.8 ‘Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol’ in Part E of Annex II to Regulation (EC) No 1333/2008 requires an update of the Union list which is not liable to have an effect on human health, since its impact on the overall exposure to polysorbates (E 432-436) is negligible. Consequently, it is not necessary to seek the opinion of the Authority. |
(10) |
For the sake of consistency, it is appropriate to address the requested use of (polysorbate 65) (E 436) by authorising the group polysorbates (E 432-436) in the respective food categories. |
(11) |
Therefore, it is appropriate to authorise the use of polysorbates (E 432-436) at the maximum level of 10 mg/kg in the food categories 14.1.4 ‘Flavoured drinks’, 14.2.3 ‘Cider and perry’, 14.2.4 ‘Fruit wine and made wine’ and 14.2.8 ‘Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol’. |
(12) |
Annex II to Regulation (EC) No 1333/2008 should therefore 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
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
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, 4 March 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 354, 31.12.2008, p. 16.
(2) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
(3) EFSA Journal 2015;13(7):4152.
(4) http://www.efsa.europa.eu/en/applications/foodingredients/tools
ANNEX
Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows:
(1) |
in food category 14.1.4 ‘Flavoured drinks’, the following new entry for polysorbates (E 432-436) is inserted after the entry for soybean hemicellulose (E 426):
|
(2) |
in food category 14.2.3 ‘Cider and perry’, the following new entry for polysorbates (E 432-436) is inserted after the entry for propane-1, 2-diol alginate (E 405):
|
(3) |
in food category 14.2.4 ‘Fruit wine and made wine’, the following new entry for polysorbates (E 432-436) is inserted after the entry for metatartaric acid (E 353):
|
(4) |
in food category 14.2.8 ‘Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol’, the following new entry for polysorbates (E 432-436) is inserted after the entry for propane-1, 2-diol alginate (E 405):
|
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/34 |
COMMISSION IMPLEMENTING REGULATION (EU) 2020/357
of 4 March 2020
amending Regulation (EU) 2018/395 as regards balloon pilot licences
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (1), and in particular Articles 23, 27 and 31 thereof,
Whereas:
(1) |
The Commission is to adopt the necessary implementing rules for establishing the requirements for balloon pilot licences (‘BPLs’) in accordance with Regulation (EU) 2018/1139, where such aircraft meet the conditions specified in points (b)(i) and (ii) of Article 2(1) of that Regulation. |
(2) |
In light of the specific nature of flight crew licensing for balloons, dedicated licensing requirements that are laid down in stand-alone regulations are necessary. Those requirements should be based on the general rules for flight crew licensing that are laid down in Commission Regulation (EU) No 1178/2011 (2). However, they should be restructured and simplified in order to ensure that they are proportionate and founded on a risk-based approach, whilst ensuring that balloon pilots are and continue to be competent to carry out their activities and to discharge their responsibilities. |
(3) |
Pursuant to Article 12(2a)(3) of Regulation (EU) No 1178/2011, Member States may continue to apply national licensing rules that provide access to basic pilot privileges until 8 April 2020. Some Member States have reported to the Commission and the European Union Aviation Safety Agency (‘EASA’) that, in that context, continuation of those national licensing rules, whereby student pilots exercise limited privileges without supervision and obtain basic privileges on a step-by-step basis supports the promotion of aerial sports and recreational activities due to easy and more affordable access to flying. Promoting and enabling such easier access to general aviation is in line with the objectives of EASA’s General Aviation Road Map that aims to create a more proportional, flexible and proactive regulatory system (3). For those reasons, Member States should be given the discretion to continue with those national licensing rules in accordance with the principles introduced in Regulation (EU) (4) for the purpose of issuing balloon pilot licences (‘BPL’). However, Member States should inform the Commission and the EASA whenever they make use of such authorisations. The Member States should also monitor the use of such authorisations in order to maintain an acceptable level of aviation safety. |
(4) |
In order to ensure a smooth transition, any certificates, authorisations and approvals issued to balloon pilots in accordance with Regulation (EU) No 1178/2011 prior to the date of application of this Regulation should continue to be valid. National balloon pilot licences issued prior to the date of application of this Regulation should be converted into licences issued in accordance with this Regulation, through conversion reports established by the competent authorities of Member States in consultation with the EASA. |
(5) |
Balloon pilot trainings that commenced in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 prior to the date of application of this Regulation, should be fully credited because they provide equal or even broader scope of training requirements than those introduced by this Regulation. Training that commenced prior to the date of application of this Regulation in accordance with Annex 1 to the Chicago Convention should be credited on the basis of credit reports established by the Member States. |
(6) |
Existing training organisations should be given the appropriate time to adapt their training programmes, where necessary, in the context of the simplified training requirements. |
(7) |
Provisions of Commission Regulation (EU) 2018/395 (5) should be updated also as regards operations with balloons, to take account of lessons learned since the adoption of that regulation and to clarify certain aspects, such as the submission of declarations for commercial activities. |
(8) |
The measures provided for in this Regulation are based on Opinion No 01/2019 (6) of the EASA in accordance with points (b) and (c) of Article 75(2) and with Article 76(1) of Regulation (EU) 2018/1139. |
(9) |
The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 127 of Regulation (EC) No 2018/1139, |
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) 2018/395 is amended as follows:
(1) |
the title is replaced by the following: ‘Commission Regulation (EU) 2018/395 of 13 March 2018 laying down detailed rules for the operation of balloons as well as for the flight crew licensing for balloons pursuant to Regulation (EU) 2018/1139 of the European Parliament and of the Council’; |
(2) |
in Article 1, paragraph 1 is replaced by the following: ‘1. This Regulation lays down detailed rules for air operations with balloons as well as for issuing and maintaining pilot licences and associated ratings, privileges and certificates for balloons, where such aircraft meet the conditions laid down in points (b)(i) and (ii) of Article (2)(1) of Regulation (EU) 2018/1139 of the European Parliament and of the Council (*1). (*1) Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).’;" |
(3) |
Article 2 is amended as follows:
|
(4) |
paragraph 2 of Article 3 is amended as follows:
|
(5) |
after Article 3, the following Articles 3a to 3d are inserted: ‘Article 3a Pilot licences and medical certification 1. Without prejudice to Commission Delegated Regulation (EU) (*3), pilots of aircraft referred to in Article 1(1) of this Regulation shall comply with the technical requirements and administrative procedures laid down in Annex III (Part-BFCL) to this Regulation and in Annex IV (Part-MED) to Regulation (EU) No 1178/2011. 2. As an exception to the privileges of the holders of licences as defined in Annex III (Part-BFCL) to this Regulation, holders of such licences may carry out flights referred to in Article 3(2)(a) to (d) without complying with point BFCL.215 of Annex III (Part-BFCL) to this Regulation. 3. A Member State may authorise student pilots who follow a balloon pilot licence (“BPL”) training course to exercise limited privileges without supervision before they meet all the requirements that are necessary for the issue of a BPL in accordance with Annex III (Part-BFCL), subject to all of the following conditions:
Article 3b Existing pilot licences and national medical certificates 1. Part-FCL licences for balloons and associated privileges, ratings and certificates issued by a Member State before the date of application of this Regulation shall be deemed to have been issued in accordance with this Regulation. Member States shall replace those licences with licences that comply with the format laid down in Annex VI (Part-ARA) to Regulation (EU) No 1178/2011 when they reissue licences for administrative reasons or upon a request of licence holders. 2. When a Member State reissues licences and associated privileges, ratings and certificates in accordance with paragraph 1 of this Article, the Member State shall, as applicable:
3. Holders of national licences for balloons issued by a Member State before the date of application of Annex III (Part-BFCL) to this Regulation shall be allowed to continue to exercise the privileges of their licences until 8 April 2021. By that date, Member States shall convert those licences into Part-BFCL licences and associated ratings, privileges and certificates in accordance with the elements laid down in a conversion report that complies with the requirements of Article 4(4) and (5) of Regulation (EU) No 1178/2011. 4. National pilot medical certificates associated with a licence as specified in paragraph 2 of this Article and issued by a Member State before the date of application of Annex III (Part-BFCL) to this Regulation shall remain valid until the date of their next revalidation or until 8 April 2021, whichever is the earliest. The revalidation of those medical certificates shall comply with the requirements of Annex IV (Part-MED) to Regulation (EU) No 1178/2011. Article 3c Credit for training that commenced prior to the date of application of this Regulation 1. In respect of issuing Part-BFCL licences and associated privileges, ratings or certificates in accordance with Annex III (Part-BFCL) to this Regulation, training that commenced prior to the date of application of this Regulation in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 shall be deemed to comply with the requirements of this Regulation, provided that the BPL is issued by 8 April 2021 at the latest. In that case, the following shall apply:
2. Training that commenced prior to the date of application of this Regulation or of Annex I (Part-FCL) to Regulation (EU) No 1178/2011, in accordance with Annex 1 to the Chicago Convention, shall be credited for the purposes of issuing Part-BFCL licences on the basis of a credit report established by the Member State in consultation with the European Union Aviation Safety Agency. 3. The credit report referred to in paragraph 2 shall describe the scope of the training, indicate for which requirements of Part-BFCL credit is given and, if applicable, which requirements applicants need to comply with in order to be issued with a Part-BFCL licence. It shall include copies of all the documents necessary to attest the scope of the training, as well as copies of the national regulations and procedures in accordance with which the training was initiated. Article 3d Training organisations 1. Training organisations for pilot licences referred to in Article 1(1) shall comply with the requirements of Article 10a of Regulation (EU) No 1178/2011. 2. Training organisations referred to in paragraph 1 of this Article which hold an approval issued in accordance with Annex VII (Part-ORA) to Regulation (EU) No 1178/2011 or have submitted a declaration in accordance with Annex VIII (Part-DTO) to Regulation (EU) No 1178/2011 before the date of application of this Regulation shall adapt their training programmes, where necessary, by 8 April 2021 at the latest. (*3) Commission Delegated Regulation (EU) of 4 March 2020 (not yet published in the Official Journal).’;" |
(6) |
Annex I (Part-DEF) is amended in accordance with Annex I to this Regulation; |
(7) |
Annex II (Part-BOP) is amended in accordance with Annex II to this Regulation; |
(8) |
Annex III (Part-BFCL) is added as set out in Annex III to this Regulation. |
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.
It shall apply from 8 April 2020.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 March 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 212, 22.8.2018, p. 1.
(2) Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 311, 25.11.2011, p. 1).
(3) https://www.easa.europa.eu/easa-and-you/general-aviation/general-aviation-road-map
(4) Commission Regulation (EU) 2019/430 of 18 March 2019 amending Regulation (EU) No 1178/2011 as regards the exercise of limited privileges without supervision before the issuance of a light aircraft pilot licence (OJ L 75 19.3.2019 p. 66).
(5) Commission Regulation (EU) 2018/395 of 13 March 2018 laying down detailed rules for the operation of balloons pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 71, 14.3.2018, p. 10).
(6) Easier access for GA pilots to IFR flying & Revision of the balloon and sailplane licensing requirements, (Opinion No 01/2019 (A) & (B), 19.02.2019), available at: https://www.easa.europa.eu/document-library/opinions
ANNEX I
Annex I ‘Definitions’ (Part-DEF) to Regulation (EU) 2018/395 is amended as follows:
(1) |
the introductory sentence is replaced by the following: ‘For the purpose of this Regulation, the following definitions and, unless terms are defined otherwise in this Annex, the definitions of Article 2 of Regulation (EU) No 1178/2011 as well as of point FCL.010 of Annex I (Part-FCL) to that Regulation, shall apply:’; |
(2) |
points 1 and 2 are replaced by the following:
|
(3) |
the following point 11a is inserted:
|
(4) |
the following points 17a and 17b are inserted:
|
(5) |
point 22 is replaced by the following:
|
(6) |
the following points 23 to 26 are added:
|
ANNEX II
Annex II ‘Balloon Air Operations’ (Part-BOP) to Regulation (EU) 2018/395 is amended as follows:
(1) |
in point BOP.BAS.010, paragraph (a) is replaced by the following:
|
(2) |
point BOP.BAS.020 is replaced by the following: ‘ BOP.BAS.020 Immediate reaction to a safety problem The operator shall implement:
|
(3) |
point BOP.BAS.025 is replaced by the following: ‘ BOP.BAS.025 Designation as pilot-in-command The operator shall designate a pilot-in-command who is qualified to act as pilot-in-command in accordance with Annex III (Part-BFCL) to this Regulation.’; |
(4) |
in point BOP.BAS.300, paragraph (c) is replaced by the following:
|
(5) |
in point BOP.ADD.005, paragraph (a) is replaced by the following:
|
(6) |
in point BOP.ADD.015, paragraph (a) is replaced by the following:
|
(7) |
point BOP.ADD.035 is replaced by the following: ‘ BOP.ADD.035 Contracted activities When contracting any part of its activity that falls within the scope of this Regulation, the operator shall be responsible for ensuring that the contracted organisation carries out the activity in accordance with the essential requirements set out in Annex V to Regulation (EU) 2018/1139 and with the requirements of this Regulation. The operator shall also ensure that the competent authority is given access to the contracted organisation in order to determine that the operator complies with those requirements.’; |
(8) |
in point BOP.ADD.040, paragraph (a) is replaced by the following:
|
(9) |
point BOP.ADD.045 is replaced by the following: ‘ BOP.ADD.045 Facility requirements The operator shall have facilities that are sufficient to allow the performance and management of all tasks and activities required to ensure compliance with the essential requirements set out in Annex V to Regulation (EU) 2018/1139 and with the requirements of this Regulation.’; |
(10) |
in point BOP.ADD.100, paragraph (a) is replaced by the following:
|
(11) |
in point BOP.ADD.105, paragraph (a) is replaced by the following:
|
(12) |
in point BOP.ADD.115, paragraph (c) is replaced by the following:
|
(13) |
in point BOP.ADD.300, paragraph (c) is replaced by the following:
|
(14) |
in point BOP.ADD.300, paragraph (e) is replaced by the following:
|
(15) |
in point BOP.ADD.305, paragraph (b) is replaced by the following:
|
(16) |
point BOP.ADD.310 is replaced by the following: ‘ BOP.ADD.310 Provision of training and checking All training and checking of flight crew members required pursuant to point BOP.ADD.315 shall be provided as follows:
|
(17) |
the Appendix is replaced by the following: ‘Appendix
|
(1) Complete the table. If there is not enough space to list the information, it shall be listed in a separate annex. The annex shall be dated and signed.
(2) “Type(s) of operation” refers to the type(s) of commercial operation conducted with the balloon.
(3) Information about the organisation responsible for the continuing airworthiness management shall include the name of the organisation, the address and the approval reference.
ANNEX III
‘ANNEX III
REQUIREMENTS FOR BALLOON FLIGHT CREW LICENSING
[PART-BFCL]
SUBPART GEN
GENERAL REQUIREMENTS
BFCL.001 Scope
This Annex establishes the requirements for the issue of a balloon pilot licence (“BPL”) and associated privileges, ratings and certificates, and the conditions for their validity and use.
BFCL.005 Competent authority
For the purpose of this Annex, the competent authority shall be an authority designated by the Member State to which a person applies for the issue of a BPL or associated privileges, ratings or certificates.
BFCL.010 Classes and groups of balloons
For the purpose of this Annex, balloons shall be categorised in the following classes and groups:
(a) |
“hot-air balloon” class:
|
(b) |
“gas balloon” class; |
(c) |
“mixed balloon” class; |
(d) |
“hot-air airship” class. |
BFCL.015 Application for and issue, revalidation and renewal of a BPL as well as associated privileges, ratings and certificates
(a) |
An application for the following shall be submitted to the competent authority in a form and manner established by that competent authority:
|
(b) |
An application specified in paragraph (a) shall be accompanied by evidence that the applicant complies with the relevant requirements established in this Annex and in Annex IV (Part-MED) to Regulation (EU) No 1178/2011. |
(c) |
Any limitation or extension of the privileges granted by a licence, rating or certificate shall be endorsed on the licence or certificate by the competent authority. |
(d) |
A person shall not hold at any time more than one BPL issued in accordance with this Annex. |
(e) |
A licence holder shall submit applications as specified in paragraph (a) to the competent authority designated by the Member State in which any of his or her licences was issued in accordance with this Annex (Part-BFCL), or Annex I (Part-FCL) to Regulation (EU) No 1178/2011 or Annex III (Part-SFCL) to Implementing Regulation (EU) 2018/1976, as applicable. |
(f) |
A BPL holder may apply for a change of competent authority to the competent authority designated by another Member State but in such case the new competent authority shall be the same for all the licences held. |
(g) |
Applicants shall apply for the issue of a BPL and associated ratings, privileges or certificates not later than 6 months after having successfully completed the skill test or assessment of competence. |
BFCL.030 Practical skill test
Except for the skill test for the commercial operation rating as specified in point BFCL.215, an applicant for a skill test shall be recommended for the test by the ATO or the DTO that is responsible for the training undertaken by the applicants, once the training is completed. The training records shall be made available to the examiner by the ATO or DTO.
BFCL.035 Crediting of flight time
Applicants for a BPL or an associated privilege, rating or certificate shall be fully credited with all solo, dual instruction or PIC flight time on balloons towards the requirement of a total flight time for the licence, privilege, rating or certificate.
BFCL.045 Obligation to carry and present documents
(a) |
When exercising the privileges of BPL licence, BPL holders shall carry all of the following:
|
(b) |
Student pilots shall carry on all solo flights:
|
(c) |
BPL holders or student pilots shall without undue delay present the documents as specified in paragraph (a) or (b) for inspection upon request by an authorised representative of the competent authority. |
BFCL.050 Recording of flight time
BPL holders and student pilots shall keep a reliable record of the details of all flights flown in a form and manner established by the competent authority.
BFCL.065 Curtailment of privileges of BPL holders aged 70 years or older in commercial passenger ballooning
BPL holders who have attained the age of 70 years shall not act as pilots of a balloon engaged in commercial passenger balloon operations.
BFCL.070 Limitation, suspension or revocation of licences, privileges, ratings and certificates
(a) |
A BPL as well as associated privileges, ratings and certificates issued in accordance with this Annex may be limited, suspended or revoked by the competent authority in accordance with the conditions and procedures laid down in Annex VI (Part-ARA) to Regulation (EU) No 1178/2011 if a BPL holder does not comply with the essential requirements set out in Annex IV to Regulation (EU) 2018/1139 or with the requirements of this Annex as well as of Annex II (Part-BOP) to this Regulation or of Annex IV (Part-MED) to Regulation (EU) No 1178/2011. |
(b) |
BPL holders shall immediately return the licence or certificate to the competent authority if their licence, privilege, rating or certificate has been limited, suspended or revoked.. |
SUBPART BPL
BALLOON PILOT LICENCE (“BPL”)
BFCL.115 BPL – Privileges and conditions
(a) |
The privileges of a BPL holder are to act as PIC in balloons:
|
(b) |
By way of derogation from paragraph (a)(1), a BPL holder who has instructor or examiner privileges may receive remuneration for:
|
(c) |
BPL holders shall exercise BPL privileges only if they comply with the applicable recency requirements and only if their medical certificate, appropriate to the privileges exercised, is valid. |
BFCL.120 BPL – Minimum age
Applicants for a BPL shall be at least 16 years of age.
BFCL.125 BPL – Student pilot
(a) |
Student pilots shall not fly solo unless authorised to do so and supervised by a flight instructor for balloons (FI(B)). |
(b) |
Student pilots shall be at least 14 years of age to be allowed on solo flights. |
BFCL.130 BPL – Training course and experience requirements
Applicants for a BPL shall complete a training course at an ATO or a DTO. The course shall be tailored to the privileges sought and shall include:
(a) |
theoretical knowledge as specified in point BFCL.135(a); |
(b) |
at least 16 hours of flight instruction in either hot-air balloons that represent group A of that class, or gas balloons, including at least:
|
BFCL.135 BPL – Theoretical knowledge examination
(a) |
Theoretical knowledge Applicants for a BPL shall demonstrate a level of theoretical knowledge that is appropriate to the privileges sought through examinations on the following:
|
(b) |
Responsibilities of the applicant
|
(c) |
Pass standards
|
(d) |
Validity period The theoretical knowledge examination shall be valid for a period of 24 months counted from the day when the applicant successfully completed the theoretical knowledge examination, in accordance with paragraph (c)(2). |
BFCL.140 BPL – Crediting of theoretical knowledge
Applicants for the issue of a BPL shall be credited towards the theoretical knowledge requirements for the common subjects as specified in point BFCL.135(a)(1) if they:
(a) |
hold a licence in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 or Annex III (Part-SFCL) to Implementing Regulation (EU) 2018/1976; or |
(b) |
have passed the theoretical knowledge examinations for a licence as specified in paragraph (a), as long as this is done within the validity period specified in point BFCL.135(d). |
BFCL.145 BPL – Practical skill test
(a) |
Applicants for a BPL shall demonstrate through the completion of a skill test the ability to perform, as PIC on a balloon, the relevant procedures and manoeuvres with competency appropriate to the privileges sought. |
(b) |
Applicants shall complete the skill test in the same class of balloons in which the training course has been completed in accordance with point BFCL.130 and, in case of hot-air balloons, in a balloon that represents group A of that class. |
(c) |
To take a skill test for the issue of a BPL, the applicant shall first pass the required theoretical knowledge examination. |
(d) |
Pass standards
|
(e) |
If the applicant fails to achieve a pass in all sections of the test within two attempts, he or she shall receive further practical training. |
BFCL.150 BPL – Extension of privileges to another balloon class or group
(a) |
The privileges of the BPL shall be limited to the class of balloon in which the skill test as specified in point BFCL.145 was taken, and, in the case of hot-air balloons, to group A of that class. |
(b) |
In the case of hot-air balloons, the privileges of the BPL shall be extended to another group within the hot-air balloon class upon application if a pilot has completed at least:
|
(c) |
Except for the mixed balloon class, the privileges of the BPL shall be extended to another balloon class, or, if privileges for the hot-air balloon class are sought, to group A of the hot-air balloon class, upon application if a pilot has completed in the relevant balloon class and group:
|
(d) |
The completion of the training as specified in paragraphs (b)(1) and (c)(1) shall be entered in the logbook of the pilot and signed by:
|
(e) |
A BPL holder shall exercise his or her privileges in the mixed balloon class only if he or she has privileges for both the hot-air balloon class and the gas balloon class. |
BFCL.160 BPL – Recency requirements
(a) |
A BPL holder shall only exercise the privileges of his or her licence if he or she has completed in the relevant balloon class:
|
(b) |
In addition to the requirements in paragraph (a), in the case of a pilot who is qualified to fly more than one class of balloons, in order to exercise his or her privileges in the other balloon class or the other balloon classes, he or she shall have completed at least three hours of flight time, as PIC or flying dual or solo under the supervision of an FI(B), on each additional balloon class within the last 24 months. |
(c) |
A BPL holder who does not comply with the requirements in paragraph (a)(1) and, if applicable, (b), before resuming the exercise of his or her privileges, shall pass a proficiency check with an FE(B) in a balloon that represents the relevant class. |
(d) |
After complying with paragraph (a), (b) or (c), as applicable, a BPL holder with privileges to fly hot-air balloons shall exercise his or her privileges only on hot-air balloons that represent:
|
(e) |
The completion of the dual flights, the flights under supervision and the training flight as specified in paragraph (a)(1) and (b), as well as the proficiency check as specified in paragraph (c) shall be entered in the logbook of the pilot and signed by, in the case of paragraphs (a)(1) and (b), the responsible FI(B) and, in the case of paragraph (c), the responsible FE(B). |
(f) |
A BPL holder, that holds also the privileges for commercial operations as specified in point BFCL.215 of Subpart ADD of this Annex, shall be deemed to comply with the requirements of:
In the case of the hot-air balloon class, limitations specified in paragraph (d), concerning the privileges to operate different classes of balloons, shall apply, depending on the balloon class used for complying with paragraphs (f)(1) or (f)(2). |
SUBPART ADD
ADDITIONAL RATINGS
BFCL.200 Tethered hot-air balloon flight rating
(a) |
A BPL holder shall undertake tethered flights with hot-air balloons only if he or she holds a tethered hot-air balloon flight rating in accordance with this point. |
(b) |
To apply for a tethered hot-air balloon flight rating, the applicant shall:
|
(c) |
The completion of the tethered hot-air balloon training shall be entered in the logbook and signed by the FI(B) who is responsible for the training. |
(d) |
A pilot who holds a tethered hot-air balloon flight rating shall exercise his or her privileges only if he or she has completed at least one tethered hot-air balloon flight during the 48 months preceding the planned flight, or, if he or she has not performed such a flight, the pilot shall exercise his or her privileges if they have performed a tethered hot-air balloon flight flying dual or solo under the supervision of an FI(B). The completion of such dual or solo flight under supervision shall be entered in the pilots logbook and signed by the FI(B). |
BFCL.210 Night rating
(a) |
A BPL holder shall exercise the privileges of his or her licence in VFR conditions at night only if he or she holds a night rating in accordance with this point. |
(b) |
An applicant for a night rating shall have completed at least two instruction flights at night of at least one hour each. |
(c) |
The completion of the night rating training shall be entered in the logbook and signed by the FI(B) who is responsible for the training. |
BFCL.215 Commercial operation rating
(a) |
A BPL holder shall exercise the privileges of his or her licence during commercial operations with balloons only if he or she holds a commercial operation rating in accordance with this point. |
(b) |
An applicant for a commercial operation rating shall:
|
(c) |
The privileges of the commercial operation rating shall be limited to the class of balloon in which the skill test in accordance with paragraph (b)(3) has been completed. The privileges shall be extended upon application to another class of balloon if, in that other class, the applicant complies with paragraph (b)(3) and (b)(4). |
(d) |
A pilot who holds a commercial operation rating shall exercise the privileges of that rating in commercial passenger ballooning only if he or she has completed:
|
(e) |
To maintain the privileges of the commercial operation rating for all balloon classes, a pilot who holds a commercial operation rating with privileges extended to more than one class of balloons shall comply with the requirements in paragraph (d)(2) in at least one class of balloons. |
(f) |
A pilot who complies with paragraph (d) and holds a commercial operation rating for the hot-air balloon class shall exercise the privileges of that rating in the hot-air balloon class only on balloons that represent:
|
(g) |
The completion of the flight under supervision as specified in paragraph (d)(1)(ii), the proficiency check as specified in paragraph (d)(2)(i) and the refresher training course as specified in paragraph (d)(2)(ii) shall be entered in the logbook of the pilot and shall be signed by the head of training of the ATO or the DTO, or the FI(B) or the FE(B) that is responsible for the training course, the supervision or the proficiency check, as applicable. |
(h) |
A pilot who has completed an operator proficiency check in accordance with point BOP.ADD.315 of Annex II (Part-BOP) to this Regulation shall be deemed to comply with paragraph (d)(2)(i). |
SUBPART FI
FLIGHT INSTRUCTORS
Section 1
General requirements
BFCL.300 Flight instructor certificates
(a) General
An instructor shall only carry out flight instruction in a balloon if he or she:
(1) |
holds:
|
(2) |
is entitled to act as PIC in the balloon during flight instruction. |
(b) Instruction provided outside the territory of the Member States
(1) |
By way of derogation from subparagraph (a)(1), in the case of flight instruction provided during a training course approved in accordance with this Annex (Part-BFCL) outside the territory for which Member States are responsible under the Chicago Convention, the competent authority shall issue a flight instructor certificate to an applicant who holds a balloon pilot licence that is compliant with Annex 1 to the Chicago Convention, provided that the applicant:
|
(2) |
The certificate shall be limited to the provision of approved flight instruction:
|
Section 2
Flight instructor certificate for balloons – FI(B)
BFCL.315 FI(B) certificate – Privileges and conditions
(a) |
Subject to compliance of applicants with point BFCL.320 and with the following conditions, an FI(B) certificate shall be issued with privileges to conduct flight instruction for:
|
(b) |
The privileges listed in paragraph (a) shall include the privileges to conduct flight instruction for:
|
BFCL.320 FI(B) – Prerequisites and requirements
Applicants for an FI(B) certificate shall:
(a) |
be at least 18 years of age; |
(b) |
comply with the requirements of subparagraphs (a)(1)(i) and (a)(2) of point BFCL.300; |
(c) |
have completed 75 hours of balloon flight time as PIC; |
(d) |
have completed an instructor training course in accordance with point BFCL.330 at an ATO or a DTO; and |
(e) |
have passed an assessment of competence in accordance with point BFCL.345. |
BFCL.325 FI(B) competencies and assessment
Applicants for an FI(B) certificate shall be trained to achieve the following competencies:
(a) |
prepare resources; |
(b) |
create a climate conducive to learning; |
(c) |
present knowledge; |
(d) |
integrate threat and error management (TEM) and crew resource management (CRM); |
(e) |
manage time to achieve training objectives; |
(f) |
facilitate learning; |
(g) |
assess trainee performance; |
(h) |
monitor and review progress; |
(i) |
evaluate training sessions; and |
(j) |
report outcome. |
BFCL.330 FI(B) – Training course
(a) |
Applicants for an FI(B) certificate shall first pass a specific pre-entry assessment at an ATO or a DTO within the 12 months preceding the start of the training course, to assess his or her ability to take the course. |
(b) |
The FI(B) training course shall include at least:
|
(c) |
Applicants who already hold an instructor certificate in accordance with Annex III (Part-SFCL) to Implementing Regulation (EU) 2018/1976 or with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 shall be fully credited towards the requirement in paragraph (b)(2). |
BFCL.345 FI(B) – Assessment of competence
(a) |
Applicants for the issue of an FI(B) certificate shall pass an assessment of competence on a balloon to demonstrate to an examiner qualified in accordance with point BFCL.415(c) the ability to instruct a student pilot to the level required for the issue of a BPL. |
(b) |
The assessment shall include:
|
BFCL.360 FI(B) certificate – Recency requirements
(a) |
An FI(B) certificate holder shall only exercise the privileges of his or her certificate if he or she has completed:
|
(b) |
The hours flown as an FE(B) during skill tests, proficiency checks or assessments of competence shall be fully credited towards the requirement in paragraph (a)(1)(ii). |
(c) |
If an FI(B) certificate holder has failed to complete the instruction flight under supervision to the satisfaction of the FI(B) in accordance with paragraph (a)(2), he or she shall not exercise the privileges of the FI(B) certificate until he or she has successfully completed an assessment of competence in accordance with point BFCL.345. |
(d) |
To resume the exercise of the privileges of the FI(B) certificate, an FI(B) certificate holder who does not comply with all the requirements of paragraph (a) shall comply with the requirement of paragraph (a)(1)(i) and of point BFCL.345. |
SUBPART FE
FLIGHT EXAMINERS
Section 1
General requirements
BFCL.400 Balloon flight examiner certificates
(a) General
An examiner shall only carry out skill tests, proficiency checks or assessments of competence in accordance with this Annex if he or she:
(1) |
holds:
|
(2) |
is entitled to act as PIC in a balloon during the skill test, proficiency check or assessment of competence. |
(b) Examinations conducted outside the territory of the Member States
(1) |
By way of derogation from paragraph (a)(1), in the case of skill tests and proficiency checks performed outside the territory for which Member States are responsible under the Chicago Convention, the competent authority shall issue an examiner certificate to an applicant who holds a balloon pilot licence that is compliant with Annex 1 to the Chicago Convention, provided that the applicant:
|
(2) |
The certificate referred to in subparagraph (1) shall be limited to performing skill tests and proficiency checks:
|
BFCL.405 Limitation of privileges in case of vested interests
A balloon examiner shall not conduct:
(a) |
a skill test or assessment of competence of an applicant for the issue of a licence, rating or certificate to whom he or she has provided more than 50 % of the required flight instruction for the licence, rating or certificate for which the skill test or assessment of competence is taken; or |
(b) |
a skill test, proficiency check or assessment of competence whenever he or she feels that his or her objectivity may be affected. |
BFCL.410 Conduct of skill tests, proficiency checks and assessments of competence
(a) |
When conducting skill tests, proficiency checks and assessments of competence, a balloon examiner shall do all of the following:
|
(b) |
After completion of the skill test, proficiency check or assessment of competence, the balloon examiner shall:
|
(c) |
The balloon examiner shall maintain the records for five years with details of all skill tests, proficiency checks and assessments of competence performed and their results. |
(d) |
Upon request by the competent authority that is responsible for the balloon examiner certificate, or the competent authority that is responsible for the applicant’s licence, the balloon examiner shall submit all records and reports, and any other information, as required, for oversight activities. |
Section 2
Flight examiner certificate for balloons – FE(B)
BFCL.415 FE(B) certificate – Privileges and conditions
Subject to compliance of the applicant with point BFCL.420 and with the following conditions, an FE(B) certificate shall be issued upon application with privileges to conduct:
(a) |
skill tests and proficiency checks for the BPL and skill tests for the extension of the privileges to another balloon class, provided that the applicant has completed 250 hours of flight time as pilot on balloons, including 50 hours of flight instruction covering the full syllabus of a BPL training course; |
(b) |
skill tests and proficiency checks for the commercial operation rating as specified in point BFCL.215, provided that the applicant complies with the experience requirements set out in paragraph (a) and has received specific training during an examiner standardisation course in accordance with point BFCL.430; |
(c) |
assessments of competence for the issue of an FI(B) certificate, provided that the applicant has:
|
BFCL.420 FE(B) certificate – Prerequisites and requirements
Applicants for an FE(B) certificate shall:
(a) |
comply with the requirements of subparagraphs (a)(1)(i) and (2) of point BFCL.400; |
(b) |
have completed the FE(B) standardisation course in accordance with point BFCL.430; |
(c) |
have completed an assessment of competence in accordance with point BFCL.445; |
(d) |
demonstrate relevant background related to the privileges of the FE(B) certificate; and |
(e) |
demonstrate that he or she has not been subject to any sanctions, including the suspension, limitation or revocation of any of his or her licences, ratings or certificates issued in accordance with this Annex, with Annex I (Part-FCL) to Regulation (EU) No 1178/2011, or with Annex III (Part-SFCL) to Implementing Regulation (EU) 2018/1976, for non-compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts during the last three years. |
BFCL.430 FE(B) certificate – Standardisation course
(a) |
Applicants for an FE(B) certificate shall take a standardisation course which is provided either by the competent authority or by an ATO or a DTO and approved by that competent authority. |
(b) |
The standardisation course shall be tailored to the balloon flight examiner privileges sought and shall consist of theoretical and practical instruction, including, at least:
|
(c) |
An FE(B) certificate holder shall not conduct skill tests, proficiency checks or assessments of competence of an applicant whose competent authority is not the one that issued the examiner certificate, unless he or she has reviewed the latest available information containing the relevant national procedures of the applicant’s competent authority. |
BFCL.445 FE(B) certificate – Assessment of competence
An applicant for the initial issue of an FE(B) certificate shall demonstrate his or her competences as an FE(B) to an inspector from the competent authority or to a senior examiner specifically authorised to do so by the competent authority that is responsible for the FE(B) certificate. During the assessment of competence, the applicant shall conduct a skill test, proficiency check or assessment of competence, including briefing, conduct of the skill test, proficiency check or assessment of competence, and assessment of the person to whom the test, check or assessment is given, debriefing and recording documentation.
BFCL.460 FE(B) certificate – Validity, revalidation and renewal
(a) |
An FE(B) certificate shall be valid for five years. |
(b) |
An FE(B) certificate shall be revalidated if its holder has:
|
(c) |
An FE(B) certificate holder who also holds one or more examiner certificates for other aircraft categories in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 or with Annex III (Part-SFCL) to Implementing Regulation (EU) 2018/1976 may achieve combined revalidation of all examiner certificates held, in agreement with the competent authority. |
(d) |
If an FE(B) certificate has expired, its holder shall comply with the requirements of paragraph (b)(1) and of point BFCL.445 before he or she can resume the exercise of the privileges of the FE(B) certificate. |
(e) |
An FE(B) certificate shall only be revalidated or renewed if the applicant demonstrates continued compliance with the requirements of point BFCL.410 as well as with the requirements of point BFCL.420(d) and (e). |
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/57 |
COMMISSION IMPLEMENTING REGULATION (EU) 2020/358
of 4 March 2020
amending Implementing Regulation (EU) 2018/1976 as regards sailplane pilot licences
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (1), and in particular Articles 23, 27 and 31 thereof,
Whereas:
(1) |
The Commission is to adopt the necessary implementing rules for establishing the requirements for sailplane pilot licences in accordance with Regulation (EU) 2018/1139, where such aircraft meet the conditions specified in points (b)(i) and (ii) of Article 2(1) of that Regulation. |
(2) |
In light of the specific nature of flight crew licensing for sailplanes, dedicated licensing requirements laid down in stand-alone regulations are necessary. Those requirements should be based on the general rules for flight crew licensing that are laid down in Commission Regulation (EU) No 1178/2011 (2). However, they should be restructured and simplified, in order to ensure that they are proportionate and founded on a risk-based approach, whilst ensuring that sailplane pilots are and continue to be competent to carry out their activities and discharge their responsibilities. Corresponding editorial update should also be made to the sailplane operations rules to take account of the shift of licensing rules from Regulation (EU) No 1178/2011 to Commission Implementing Regulation (EU) 2018/1976 (3). |
(3) |
Pursuant to Article 12(2a)(3) of Regulation (EU) No 1178/2011, Member States may continue to apply national licensing rules that provide access to basic pilot privileges until 8 April 2020. Some Member States have reported to the Commission and the European Union Aviation Safety Agency (‘EASA’) that, in that context, continuation of those national licencing rules, whereby student pilots are allowed to exercise limited privileges without supervision and obtain basic privileges on a step-by-step basis, supports the promotion of aerial sports and recreational activities due to easy and more affordable access to flying. Promoting and enabling such easier access to general aviation is in line with objectives of EASA’s General Aviation Road Map that aims to create a more proportional, flexible and proactive regulatory system (4). For those reasons, Member States should be given the discretion to continue with those national licensing rules in accordance with the principles introduced in Commission Implementing Regulation (EU) 2019/430 (5), for the purpose of issuing sailplane pilot licences (‘SPL’). However, Member States should inform the Commission and the EASA whenever they make use of such authorisations. The Member States should also monitor the use of such authorisations in order to maintain an acceptable level of aviation safety. |
(4) |
In order to ensure a smooth transition, any certificates, authorisations and approvals issued to sailplane pilots in accordance with Regulation (EU) No 1178/2011 prior to the date of application of this Regulation should continue to be valid. National sailplane pilot licences issued prior to the date of application of this Regulation should be converted into licences issued in accordance with this Regulation, through conversion reports established by the competent authorities of Member States in consultation with the EASA. |
(5) |
Sailplane pilot trainings that commenced in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 prior to the date of application of this Regulation should be fully credited because they provide equal or even broader scope of training requirements than those introduced by this Regulation. Training that commenced prior to the date of application of this Regulation in accordance with Annex 1 to the Chicago Convention should be credited on the basis of credit reports established by the Member States. |
(6) |
Existing training organisations should be given the appropriate time to adapt their training programmes, where necessary, in the context of the simplified training requirements. |
(7) |
The measures provided for in this Regulation are based on Opinion No 01/2019 (6) of the EASA in accordance with points (b) and (c) of Article 75(2) and with Article 76(1) of Regulation (EU) 2018/1139. |
(8) |
The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 127 of Regulation (EU) 2018/1139, |
HAS ADOPTED THIS REGULATION:
Article 1
Implementing Regulation (EU) 2018/1976 is amended as follows:
(1) |
the title is replaced by the following: ‘Commission Implementing Regulation (EU) 2018/1976 of 14 December 2018 laying down detailed rules for the operation of sailplanes as well as for the flight crew licensing for sailplanes pursuant to Regulation (EU) 2018/1139 of the European Parliament and of the Council’; |
(2) |
in Article 1, paragraph 1 is replaced by the following: ‘1. This Regulation lays down detailed rules for air operations with sailplanes as well as for issuing and maintaining pilot licences and associated ratings, privileges and certificates for sailplanes, where such aircraft meet the conditions laid down in points (b)(i) and (ii) of Article 2(1) of Regulation (EU) 2018/1139.’; |
(3) |
Article 2 is amended as follows:
|
(4) |
the following Articles 3a to 3d are inserted after Article 3: ‘Article 3a Pilot licences and medical certification 1. Without prejudice to Commission Delegated Regulation (EU) (*1), pilots of aircraft referred to in Article 1(1) of this Regulation shall comply with the technical requirements and administrative procedures laid down in Annex III (Part-SFCL) to this Regulation and in Annex IV (Part-MED) to Regulation (EU) No 1178/2011. 2. As an exception to the privileges of the holders of licences as defined in Annex III (Part-SFCL) to this Regulation, holders of such licences may carry out flights referred to in points (a) to (d) of Article 3(2) without complying with point SFCL.115(a)(3) of Annex III (Part-SFCL) to this Regulation. 3. A Member State may authorise student pilots who follow a sailplane pilot licence (‘SPL’) training course to exercise limited privileges without supervision before they meet all the requirements that are necessary for the issue of an SPL in accordance with Annex III (Part-SFCL) to this Regulation, subject to all of the following conditions:
Article 3b Existing pilot licences and national medical certificates 1. Part-FCL licences for sailplanes and associated privileges, ratings and certificates issued by a Member State before the date of application of this Regulation shall be deemed to have been issued in accordance with this Regulation. Member States shall replace those licences with licences that comply with the format laid down in Annex VI (Part-ARA) to Regulation (EU) No 1178/2011 when they reissue licences for administrative reasons or upon a request of licence holders. 2. When a Member State reissues licences and associated privileges, ratings and certificates in accordance with paragraph 1, the Member State shall, as applicable:
3. Holders of national licences for sailplanes issued by a Member State before the date of application of Annex III (Part-SFCL) to this Regulation shall be allowed to continue to exercise the privileges of their licences until 8 April 2021. By that date, Member States shall convert those licences into Part-SFCL licences and associated ratings, privileges and certificates in accordance with the elements laid down in a conversion report that complies with the requirements of Article 4(4) and (5) of Regulation (EU) No 1178/2011. 4. National pilot medical certificates associated with a licence as specified in paragraph 2 of this Article and issued by a Member State before the date of application of Annex III (Part-SFCL) to this Regulation shall remain valid until the date of their next revalidation or until 8 April 2021, whichever is the earliest. The revalidation of such medical certificates shall comply with the requirements of Annex IV (Part-MED) to Regulation (EU) No 1178/2011. Article 3c Credit for training that commenced prior to the date of application of this Regulation 1. In respect of issuing Part-SFCL licences and associated privileges, ratings or certificates in accordance with Annex III (Part-SFCL) to this Regulation, training that commenced prior to the date of application of this Regulation in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 shall be deemed to comply with the requirements of this Regulation. 2. Training that commenced prior to the date of application of this Regulation or of Annex I (Part-FCL) to Regulation (EU) No 1178/2011, in accordance with Annex 1 to the Chicago Convention, shall be credited for the purposes of issuing Part-SFCL licences on the basis of a credit report established by the Member State in consultation with the EASA. 3. The credit report referred to in paragraph 2 shall describe the scope of the training, indicate for which requirements of Part-SFCL credit is given and, if applicable, which requirements applicants need to comply with in order to be issued with a Part-SFCL licence. It shall include copies of all the documents necessary to attest the scope of the training, as well as copies of the national regulations and procedures in accordance with which the training was initiated. Article 3d Training organisations 1. Training organisations for obtaining the pilot licences referred to in Article 1(1) of this Regulation shall comply with the requirements of Article 10a of Regulation (EU) No 1178/2011. 2. Training organisations referred to in paragraph 1 which hold an approval issued in accordance with Annex VII (Part-ORA) to Regulation (EU) No 1178/2011 or have submitted a declaration in accordance with Annex VIII (Part-DTO) to Regulation (EU) No 1178/2011 before the date of application of this Regulation shall adapt their training programmes, where necessary, by 8 April 2021 at the latest. (*1) Commission Delegated Regulation (EU) of 4 March 2020 (not yet published in the Official Journal).’;" |
(5) |
Annex I (Part-DEF) is amended in accordance with Annex I to this Regulation; |
(6) |
Annex II (Part-SAO) is amended in accordance with Annex II to this Regulation |
(7) |
Annex III (Part-SFCL) is added as set out in Annex III to this Regulation. |
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.
It shall apply from 8 April 2020.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 March 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 212, 22.8.2018, p. 1.
(2) Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 311, 25.11.2011, p. 1).
(3) Commission Implementing Regulation (EU) 2018/1976 of 14 December 2018 laying down detailed rules for the operation of sailplanes pursuant to Regulation (EU) 2018/1139 of the European Parliament and of the Council (OJ L 326, 20.12.2018, p. 64).
(4) https://www.easa.europa.eu/easa-and-you/general-aviation/general-aviation-road-map
(5) Commission Implementing Regulation (EU) 2019/430 of 18 March 2019 amending Regulation (EU) No 1178/2011 as regards the exercise of limited privileges without supervision before the issuance of a light aircraft pilot licence (OJ L 75, 19.3.2019, p. 66).
(6) Easier access for GA pilots to IFR flying & Revision of the balloon and sailplane licensing requirements, (Opinion No 01/2019 (A) & (B), 19.02.2019), available at: https://www.easa.europa.eu/document-library/opinions
ANNEX I
Annex I ‘Definitions’ (Part-DEF) to Regulation (EU) 2018/1976 is amended as follows:
(1) |
the introductory sentence is replaced by the following: ‘For the purpose of this Regulation, the following definitions and, unless terms are defined otherwise in this Annex, the definitions of Article 2 of Commission Regulation (EU) No 1178/2011 as well as of point FCL.010 of Annex I (Part-FCL) to that Regulation, shall apply:’; |
(2) |
point 13 is replaced by the following:
|
(3) |
the following points 14 to 19 are added:
|
ANNEX II
Annex II (Part-SAO) to Regulation (EU) 2018/1976 is amended as follows:
(1) |
Point SAO.GEN.125 ‘Designation of the pilot-in-command’ is replaced by the following: ‘ Point SAO.GEN.125 Designation of the pilot-in-command The operator shall designate a pilot-in-command who is qualified to act as pilot-in-command in accordance with Annex III to this Regulation.’. |
ANNEX III
The following Annex III to Regulation (EU) 2018/1976 is added after Annex II:
‘ANNEX III
REQUIREMENTS FOR SAILPLANE FLIGHT CREW LICENSING
[PART-SFCL]
SUBPART GEN
GENERAL REQUIREMENTS
SFCL.001 Scope
This Annex establishes the requirements for the issue of a sailplane pilot licence (‘SPL’) and associated privileges, ratings and certificates, and the conditions for their validity and use.
SFCL.005 Competent authority
For the purpose of this Annex, the competent authority shall be an authority designated by the Member State to which a person applies for the issue of an SPL or associated privileges, ratings or certificates.
SFCL.015 Application for and issue, revalidation and renewal of an SPL as well as associated privileges, ratings and certificates
(a) |
The following shall be submitted to the competent authority in a form and manner established by that competent authority:
|
(b) |
An application as specified in paragraph (a) shall be accompanied by evidence that the applicant complies with the relevant requirements established in this Annex and in Annex IV (Part-MED) to Regulation (EU) No 1178/2011. |
(c) |
Any limitation or extension of the privileges granted by a licence, rating or certificate shall be endorsed on the licence or certificate by the competent authority, except for obtaining the privileges as specified in paragraph (a)(1)(ii). |
(d) |
A person shall not hold at any time more than one SPL issued in accordance with this Annex. |
(e) |
A licence holder shall submit applications as specified in paragraph (a) to the competent authority designated by the Member State in which any of his or her licences was issued in accordance with this Annex (Part-SFCL), or Annex I (Part-FCL) to Regulation (EU) No 1178/2011 or Annex III (Part-BFCL) to Regulation (EU) 2018/395, as applicable. |
(f) |
An SPL holder may apply for a change of competent authority to the competent authority designated by another Member State but in such case the new competent authority shall be the same for all the licences held. |
(g) |
Applicants shall apply for the issue of an SPL and associated ratings, privileges or certificates not later than six months after having successfully completed the skill test or assessment of competence. |
SFCL.030 Practical skill test
Applicants for a skill test shall be recommended for the skill test by the ATO or the DTO that is responsible for the training undertaken by the applicants, once the training is completed. The training records shall be made available to the examiner by the ATO or DTO.
SFCL.035 Crediting of flight time
Applicants for an SPL or an associated privilege, rating or certificate shall be fully credited with all solo, dual instruction or PIC flight time on sailplanes towards the requirement of a total flight time for the licence, privilege, rating or certificate.
SFCL.045 Obligation to carry and present documents
(a) |
When exercising the privileges of SPL licence, SPL holders shall carry all of the following:
|
(b) |
Student pilots shall carry on all solo cross-country flights:
|
(c) |
SPL holders or student pilots shall without undue delay present the documents as specified in paragraph (a) for inspection upon request by an authorised representative of the competent authority. |
(d) |
By way of derogation from paragraphs (a) and (b), the documents specified therein may be retained at the aerodrome or operating site for flights that remain:
|
SFCL.050 Recording of flight time
SPL holders and student pilots shall keep a reliable record of the details of all flights flown in a form and manner established by the competent authority.
SFCL.065 Curtailment of privileges of SPL holders aged 70 years or older in commercial passenger sailplane operations
SPL holders who have attained the age of 70 years shall not act as pilots of sailplanes engaged in commercial passenger sailplane operations.
SFCL.070 Limitation, suspension and revocation of licences, privileges, ratings and certificates
(a) |
An SPL as well as associated privileges, ratings and certificates issued in accordance with this Annex may be limited, suspended or revoked by the competent authority in accordance with the conditions and procedures laid down in Annex VI (Part-ARA) to Regulation (EU) No 1178/2011 if an SPL holder does not comply with the essential requirements set out in Annex IV to Regulation (EU) 2018/1139 or with the requirements of this Annex as well as of Annex II (Part-SAO) to this Regulation or with Annex IV (Part-MED) to Regulation (EU) No 1178/2011. |
(b) |
SPL holders shall immediately return the licence or certificate to the competent authority if their licence, privilege, rating or certificate has been limited, suspended or revoked. |
SUBPART SPL
SAILPLANE PILOT LICENCE (‘SPL’)
SFCL.115 SPL – Privileges and conditions
(a) |
Subject to compliance with point SFCL.150, the privileges of SPL holders are to act as PIC in sailplanes:
|
(b) |
By way of derogation from paragraph (a), SPL holders who have instructor or examiner privileges may receive remuneration for:
|
(c) |
SPL holders shall exercise SPL privileges only if they comply with the applicable recency requirements and only if their medical certificate, appropriate to the privileges exercised, is valid. |
(d) |
The completion of the training flight as specified in paragraph (a)(2)(ii)(A) shall be entered in the logbook of the pilot and signed by the instructor who is responsible for the training flight. |
SFCL.120 SPL – Minimum age
Applicants for an SPL shall be at least 16 years old.
SFCL.125 SPL – Student pilot
(a) |
Student pilots shall not fly solo unless authorised to do so and supervised by an FI(S). |
(b) |
Student pilot shall be at least 14 years of age to be allowed on solo flights. |
SFCL.130 SPL – Training course and experience requirements
(a) |
Applicants for an SPL shall complete a training course at an ATO or a DTO. The course shall be tailored to the privileges sought and shall include:
|
(b) |
Applicants who hold a pilot licence for another category of aircraft, with the exception of balloons licence, shall be credited with 10 % of total flight time as PIC on such aircraft and up to a maximum of seven hours. The amount of credit given shall in any case:
|
SFCL.135 SPL – Theoretical knowledge examination
(a) |
Theoretical knowledge Applicants for an SPL shall demonstrate a level of theoretical knowledge that is appropriate to the privileges sought through examinations on the following:
|
(b) |
Responsibilities of the applicant
|
(c) |
Pass standards
|
(d) |
Validity period The successful completion of the theoretical knowledge examinations shall be valid for a period of 24 months, counted from the day when the applicant successfully completed the theoretical knowledge examination, in accordance with paragraph (c)(2). |
SFCL.140 SPL – Crediting of theoretical knowledge
Applicants for the issue of an SPL shall be credited towards the theoretical knowledge requirements for the common subjects as specified in point SFCL.135(a)(1) if they:
(a) |
hold a licence in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 or with Annex III (Part-BFCL) to Regulation (EU) 2018/395; or |
(b) |
have passed the theoretical knowledge examinations for a licence as specified in paragraph (a), as long as this is done within the validity period specified in point SFCL.135(d). |
SFCL.145 SPL – Practical skill test
(a) |
Applicants for an SPL shall demonstrate through the completion of a skill test the ability to perform, as PIC on sailplanes, the relevant procedures and manoeuvres with competency appropriate to the privileges sought. |
(b) |
Applicants shall complete the skill test in a sailplane, excluding TMGs, or a TMG, depending on the privileges sought and provided that the training course in accordance with point SFCL.130 included the necessary training elements for the relevant aircraft. An applicant who has completed a training course, including the necessary training elements for both sailplanes and TMGs, may complete 2 skill tests, 1 in a sailplane, excluding TMGs, and 1 in a TMG, in order to obtain privileges for both aircraft. |
(c) |
To take a skill test for the issue of an SPL the applicant shall first pass the required theoretical knowledge examinations. |
(d) |
Pass standards
|
(e) |
If the applicant fails to achieve a pass in all sections of the test within two attempts he or she shall receive further practical training. |
SFCL.150 SPL – Sailplane and TMG privileges
(a) |
If the skill test as specified in point SFCL.145 has been completed in a sailplane, excluding TMGs, the privileges of an SPL shall be limited to sailplanes, excluding TMGs. |
(b) |
In the case specified in paragraph (a), the privileges of an SPL shall be extended to TMGs upon application if a pilot has:
|
(c) |
Holders of a licence issued in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 shall receive full credit towards the requirements in paragraph (b) provided that they:
|
(d) |
If the skill test as specified in point SFCL.145 has been completed in a TMG, the privileges of the SPL shall be limited to TMGs. |
(e) |
In the case specified in paragraph (d), the privileges of the SPL shall be extended to sailplanes upon application if a pilot has:
|
(f) |
The completion of the training as specified in paragraphs (b)(1) and (e)(1) shall be entered in the logbook of the pilot and signed by the head of training of the ATO or the DTO that is responsible for the training. |
SFCL.155 SPL – Launching methods
(a) |
SPL holders shall exercise their privileges only by using those launching methods for which they have completed a specific training either during the training course in accordance with point SFCL.130 or point SFCL.150(e)(1) or during additional training provided by an instructor after the issue of the SPL. This specific training shall consist of the following:
|
(b) |
The completion of the training as specified in paragraph (a) shall be entered in the logbook of the pilot and signed by the head of training of the ATO or the DTO or the instructor that is responsible for the training, as applicable. |
(c) |
In order to maintain the privileges for each launching method and in accordance with the requirements of paragraphs (a) and (b), SPL holders shall complete a minimum of five launches during the last two years, except for bungee launch, in which case they shall complete only two launches. In the case of self-launch, launches may be done in self-launch or through take-offs in TMGs or a combination of these. |
(d) |
If SPL holders do not comply with the requirement in paragraph (c), in order to renew their privileges they shall perform the additional number of launches flying dual or solo under the supervision of an instructor. |
SFCL.160 SPL – Recency requirements
(a) |
Sailplanes, excluding TMGs SPL holders shall exercise SPL privileges, excluding TMGs, only if in the last 24 months before the planned flight they:
|
(b) |
TMGs SPL holders shall exercise their TMG privileges only if in the last 24 months before the planned flight they:
|
(c) |
SPL holders with privileges to fly on TMGs who also hold a licence including the privileges to fly on TMGs in accordance with the provisions of Annex I (Part-FCL) to Regulation (EU) No 1178/2011 shall be exempted from complying with paragraph (b). |
(d) |
The completion of the dual flights, the flights under supervision and the training flights as specified in paragraphs (a)(1) and (b)(1), as well as the proficiency checks as specified in paragraph (a)(2) and (b)(2) shall be entered in the logbook of the pilot and signed by the responsible FI(S) in the case of paragraphs (a)(1) and (b)(1), and by the responsible FE(S) in the case of paragraphs (a)(2) and (b)(2). |
(e) |
Carriage of passengers SPL holders shall carry passengers only if in the preceding 90 days they have carried out as PIC, at least:
|
SUBPART ADD
ADDITIONAL RATINGS AND PRIVILEGES
SFCL.200 Aerobatic privileges
(a) |
SPL holders shall only undertake aerobatic flights in sailplanes with any engine stopped, or, in the case of paragraph (d) and (e), with engine power, if they hold the appropriate aerobatic privileges in accordance with this point. |
(b) |
Basic aerobatic privileges:
|
(c) |
Advanced aerobatic privileges:
|
(d) |
The basic or advanced aerobatic privileges shall include aerobatic flights in sailplanes with engine power, if a pilot has received a training in aerobatic flight in sailplanes with engine power during a training course in accordance with paragraphs (b)(2)(ii) or (c)(2)(ii), as applicable. |
(e) |
The privileges of an SPL shall include advanced aerobatic privileges for TMGs flown with engine power if a pilot also has or has had an aerobatic rating in accordance with point FCL.800 of Annex I (Part-FCL) to Regulation (EU) No 1178/2011, including privileges for aerobatic flight on TMGs. |
(f) |
The completion of the training course as specified in paragraphs (b)(2)(ii) and (c)(2)(ii) and, as applicable, the inclusion of training specified in paragraph (d), shall be entered in the logbook and signed by the head of training of the ATO or the DTO that is responsible for the training. |
SFCL.205 Sailplane towing and banner towing rating
(a) |
SPL holders who have privileges to fly TMGs shall tow sailplanes or banners only if they hold an appropriate sailplane towing or banner towing rating in accordance with this point. |
(b) |
Applicants for a sailplane towing rating shall have completed:
|
(c) |
Applicants for a banner towing rating shall have completed:
|
(d) |
Applicants for a sailplane towing rating or a banner towing rating in accordance with this point who already hold a sailplane towing or banner towing rating in accordance with point FCL.805(b) of Annex I (Part-FCL) to Regulation (EU) No 1178/2011 or who have fulfilled all the requirements for the issue of that rating, as applicable, shall:
|
(e) |
The completion of the training course as specified in paragraphs (b)(2), (c)(2) and (d)(2) shall be entered in the logbook and signed by the head of training of the ATO or the DTO or the instructor who is responsible for the training, as applicable. |
(f) |
To exercise the privileges of the sailplane towing or banner towing rating, the holder of the rating shall complete a minimum of five tows during the last two years. |
(g) |
If a holder of the sailplane towing rating does not comply with the requirement in paragraph (f), before resuming the exercise of his or her privileges, he or she shall complete the missing tows with or under the supervision of an instructor. |
SFCL.210 TMG night rating
(a) |
SPL holders with privileges to fly TMGs shall only exercise their TMG privileges in VFR conditions at night if they hold a TMG night rating in accordance with this point. |
(b) |
Applicants for a TMG night rating shall first complete a training course at an ATO or a DTO. The course shall comprise:
|
(c) |
To complete the training at night, an SPL holder shall first complete the basic instrument flight training necessary for the issue of a private pilot licence (PPL) in accordance with the provisions of Annex I (Part-FCL) to Regulation (EU) No 1178/2011. |
(d) |
Applicants for a TMG night rating in accordance with this point shall receive full credit towards the requirements of paragraphs (b) and (c) if they hold a night rating in accordance with point FCL.810 of Annex I (Part-FCL) to Regulation (EU) No 1178/2011 or if they have fulfilled all the requirements for the issue of that rating. |
SFCL.215 Sailplane cloud flying privileges
(a) |
SPL holders shall operate a sailplane within cloud only if:
|
(b) |
The privileges of an SPL shall include sailplane cloud flying privileges if a pilot has completed at least:
|
(c) |
In order to obtain sailplane cloud flying privileges, an SPL holder who also holds a basic instrument rating (BIR) or an IR(A) in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 or who has fulfilled all the requirements for the issue of one of these ratings, shall:
|
(d) |
The completion of the training course as specified in paragraphs (b)(2) or (c)(2), as applicable, shall be entered in the logbook and signed by the head of training of the ATO or the DTO that is responsible for the training. |
(e) |
SPL holders shall exercise their sailplane cloud flying privileges only if in the last two years before the planned cloud flight they have completed at least one hour of flight time, or five flights, as PIC exercising cloud flying privileges in sailplanes. |
(f) |
If SPL holders with sailplane cloud flying privileges do not comply with the requirements in paragraph (e) and they wish to resume the exercise of their sailplane cloud flying privileges they shall:
|
(g) |
SPL holders with sailplane cloud flying privileges who also hold a BIR or an IR(A) in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 shall be fully credited towards the requirements of paragraph (e). |
SUBPART FI
FLIGHT INSTRUCTORS
Section 1
General requirements
SFCL.300 Flight instructor certificate
(a) |
General An instructor shall only carry out flight instruction in a sailplane if he or she:
|
(b) |
Instruction provided outside the territory of the Member States
|
Section 2
Flight instructor certificate for sailplanes – FI(S)
SFCL.315 FI(S) certificate – Privileges and conditions
(a) |
Subject to compliance of the applicants with point SFCL.320 and with the following conditions, an FI(S) certificate shall be issued with privileges to conduct flight instruction for:
|
(b) |
The privileges listed in paragraph (a) shall include the privileges to conduct flight instruction for:
|
SFCL.320 FI(S) certificate – Prerequisites and requirements
Applicants for an FI(S) certificate shall:
(a) |
be at least 18 years of age; |
(b) |
comply with the requirements of point (a)(1)(i) and paragraph (2) of point SFCL.300; |
(c) |
have completed 100 hours of flight time and 200 launches as PIC on sailplanes; |
(d) |
have completed an instructor training course in accordance with point SFCL.330 at an ATO or a DTO; and |
(e) |
have passed an assessment of competence in accordance with point SFCL.345. |
SFCL.325 FI(S) competencies and assessment
Applicants for an FI(S) certificate shall be trained to achieve the following competencies:
(a) |
prepare resources; |
(b) |
create a climate conducive to learning; |
(c) |
present knowledge; |
(d) |
integrate threat and error management (TEM) and crew resource management (CRM); |
(e) |
manage time to achieve training objectives; |
(f) |
facilitate learning; |
(g) |
assess trainee performance; |
(h) |
monitor and review progress; |
(i) |
evaluate training sessions; and |
(j) |
report outcome. |
SFCL.330 FI(S) – Training course
(a) |
Applicants for an FI(S) certificate shall first pass a specific pre-entry assessment at an ATO or a DTO, which shall take place within the 12 months preceding the start of the training course, to assess their ability to undertake the course. |
(b) |
The FI(S) training course shall include:
|
(c) |
Applicants who already hold an instructor certificate in accordance with Annex III (Part-BFCL) to Regulation (EU) 2018/395 or with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 shall be fully credited towards the requirement in paragraph (b)(1)(ii). |
(d) |
When applying for an FI(S) certificate, a pilot who holds or has held an FI(A), (H) or (As) shall be credited with 18 hours towards the requirements in paragraph (b)(1)(iii). |
SFCL.345 FI(S) – Assessment of competence
(a) |
Applicants for the issue of an FI(S) certificate shall pass an assessment of competence to demonstrate to an examiner qualified in accordance with point SFCL.415(c) the ability to instruct a student pilot to the level required for the issue of an SPL. |
(b) |
The assessment shall include:
|
(c) |
The assessment of competence for the initial issue of an FI(S) certificate shall be conducted in sailplanes, excluding TMGs. |
SFCL.350 FI(S) – Restricted privileges
(a) |
An FI(S) shall have his or her privileges limited to conducting flight instruction under the supervision of an unrestricted FI(S) nominated by the ATO or the DTO for this purpose, in the following cases:
|
(b) |
Whilst conducting training under supervision, in accordance with paragraph (a), the FI(S) shall not have the privilege to authorise a student pilot to conduct his or her first solo flight or first solo cross-country flight. |
(c) |
The limitations in (a) and (b) shall be removed from the FI(S) certificate after the FI(S) has completed at least 15 hours or 50 launches of flight instruction covering all phases of a sailplane flight. In the case of a restricted FI(S) who complied with point SFCL.330(b)(2), 5 out of those 15 hours may be completed in TMGs, and 15 out of those 50 launches may be replaced by take-offs and landings in TMGs. |
SFCL.360 FI(S) certificate – Recency requirements
(a) |
An FI(S) certificate holder shall only exercise the privileges of his or her certificate if before the planned exercise of those privileges he or she has:
|
(b) |
The hours flown as an FE(S) during skill tests, proficiency checks and assessments of competence shall be fully credited towards the requirement in paragraph (a)(1)(ii). |
(c) |
If the FI(S) certificate holder has failed to complete the instruction flight under supervision to the satisfaction of the FI(S) in accordance with paragraph (a)(2), he or she shall not exercise the privileges of the FI(S) certificate until he or she has successfully completed an assessment of competence in accordance with point SFCL.345. |
(d) |
To resume the exercise of the privileges of the FI(S) certificate, an FI(S) certificate holder who does not comply with all the requirements in paragraph (a) shall comply with the requirements of paragraph (a)(1)(i) and of point SFCL.345. |
SUBPART FE
FLIGHT EXAMINERS
Section 1
General requirements
SFCL.400 Sailplane flight examiner certificates
(a) |
General An examiner shall only carry out skill tests, proficiency checks or assessments of competence in accordance with this Annex if he or she:
|
(b) |
Examinations conducted outside the territory of the Member States
|
SFCL.405 Limitation of privileges in case of vested interests
A sailplane examiner shall not conduct:
(a) |
a skill test or assessment of competence of an applicant for the issue of a licence, rating or certificate to whom he or she has provided more than 50 % of the required flight instruction for the licence, rating or certificate for which the skill test or assessment of competence is taken; or |
(b) |
a skill test, proficiency check or assessment of competence whenever he or she feels that his or her objectivity may be affected. |
SFCL.410 Conduct of skill tests, proficiency checks and assessments of competence
(a) |
When conducting skill tests, proficiency checks and assessments of competence, a sailplane examiner shall do all of the following:
|
(b) |
After completion of the skill test, proficiency check or assessment of competence, the sailplane examiner shall:
|
(c) |
The sailplane examiner shall maintain the records for five years with details of all skill tests, proficiency checks and assessments of competence performed and their results. |
(d) |
Upon request by the competent authority that is responsible for the sailplane examiner certificate, or the competent authority that is responsible for the applicant’s licence, the sailplane examiner shall submit all records and reports, and any other information, as required, for oversight activities. |
Section 2
Flight examiner certificate for sailplanes – FE(S)
SFCL.415 FE(S) certificate – Privileges and conditions
Subject to compliance of the applicant with point SFCL.420 and with the following conditions, an FE(S) certificate shall be issued upon application with privileges to conduct:
(a) |
skill tests and proficiency checks for the SPL, provided that the applicant has completed, on sailplanes, excluding TMGs, 300 hours of flight time as a pilot, including 150 hours or 300 launches of flight instruction; |
(b) |
skill tests for the extension of the SPL privileges to TMG in accordance with point SFCL.150(e), provided that the applicant has completed 300 hours of flight time on sailplanes, including 50 hours of flight instruction in TMGs; |
(c) |
assessments of competence for the issue of FI(S) certificates on sailplanes, provided that the applicant has:
|
SFCL.420 FE(S) certificate – Prerequisites and requirements
Applicants for an FE(S) certificate shall:
(a) |
comply with the requirements of point (a)(1)(i) and paragraph (a)(2) of point SFCL.400; |
(b) |
have completed the FE(S) standardisation course in accordance with point SFCL.430; |
(c) |
have completed an assessment of competence in accordance with point SFCL.445; |
(d) |
demonstrate relevant background related to the privileges of the FE(S) certificate; and |
(e) |
demonstrate that they have not been subject to any sanctions, including the suspension, limitation or revocation of any of his or her licences, ratings or certificates issued in accordance with this Annex, with Annex I (Part-FCL) to Regulation (EU) No 1178/2011, or with Annex III (Part-BFCL) to Regulation (EC) No 2018/395, for non-compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts during the last three years. |
SFCL.430 FE(S) certificate – Standardisation course
(a) |
Applicants for an FE(S) certificate shall take a standardisation course which is provided either by the competent authority or by an ATO or a DTO and approved by that competent authority. |
(b) |
The standardisation course shall be tailored to the sailplane flight examiner privileges sought and shall consist of theoretical and practical instruction, including, at least:
|
(c) |
An FE(S) certificate holder shall not conduct skill tests, proficiency checks or assessments of competence of an applicant whose competent authority is not the one that issued the examiner certificate, unless he or she has reviewed the latest available information containing the relevant national procedures of the applicant’s competent authority. |
SFCL.445 FE(S) certificate – Assessment of competence
An applicant for the initial issue of an FE(S) certificate shall demonstrate his or her competence as an FE(S), to an inspector from the competent authority or to a senior examiner specifically authorised to do so by the competent authority that is responsible for the FE(S) certificate. During the assessment of competence, the applicant shall conduct a skill test, proficiency check or assessment of competence, including briefing, conduct of the skill test, proficiency check or assessment of competence, and assessment of the person to whom the test, check or assessment is given, debriefing and recording documentation.
SFCL.460 FE(S) certificate – Validity, revalidation and renewal
(a) |
An FE(S) certificate shall be valid for five years. |
(b) |
An FE(S) certificate shall be revalidated if its holder has:
|
(c) |
An FE(S) certificate holder who also holds one or more examiner certificates for other aircraft categories in accordance with Annex I (Part-FCL) to Regulation (EU) No 1178/2011 or with Annex III (Part-BFCL) to Regulation (EU) 2018/395 may achieve combined revalidation of all examiner certificates held, in agreement with the competent authority. |
(d) |
If an FE(S) certificate has expired, its holder shall comply with the requirements of paragraph (b)(1) and of point SFCL.445 before he or she can resume the exercise of the privileges of the FE(S) certificate. |
(e) |
An FE(S) certificate shall only be revalidated or renewed if the applicant demonstrates continued compliance with the requirements of point SFCL.410 as well as with the requirements of point SFCL.420(d) and (e). |
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/82 |
COMMISSION IMPLEMENTING REGULATION (EU) 2020/359
of 4 March 2020
amending Regulation (EU) No 1178/2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (1), and in particular Articles 23 and 27 thereof,
Whereas:
(1) |
Commission Regulation (EU) No 1178/2011 (2) lays down the requirements for pilots who are involved in the operation of aircraft as specified in points (b)(i) and (ii) of Article 2(1) of Regulation (EU) 2018/1139. |
(2) |
In light of the specific nature of flight crew licensing for balloons and sailplanes, dedicated licensing requirements should be laid down in separate regulations, namely in Commission Regulation (EU) 2018/395 (3) and Commission Implementing Regulation (EU) 2018/1976 (4). |
(3) |
At the same time, the licensing requirements for balloon and sailplane pilot licences laid down in Annex I (Part-FCL) to Regulation (EU) No 1178/2011 should be deleted and some requirements of Annex I (Part-FCL) that address cross-domain issues, such as crediting provisions between balloon or sailplane pilot licences and licences for other aircraft categories, should be revised in light of the new licensing requirements for balloon and sailplane pilots. |
(4) |
The requirements of Annex IV (Part-MED) Annex VI (Part-ARA), Annex VII (Part-ORA) and Annex VIII (Part-DTO) to Regulation (EU) No 1178/2011 should continue to apply to balloon and sailplane flight crew licensing. |
(5) |
In order to further improve aviation safety, pilots that are engaged in aerial sport and recreational activities should be encouraged to obtain privileges for flying in accordance with instrument flight rules (‘IFR’). Therefore, the existing rules concerning IFR privileges should be adapted by introducing the basic instrument rating (‘BIR’) in Annex I (Part-FCL) to Regulation (EU) No 1178/2011. The BIR should be specifically tailored to the needs of pilots who are engaged in aerial sport and recreational flying activities as regards the content of their training and the scope of their privileges. |
(6) |
With the introduction of the BIR, the en route instrument rating (‘EIR’) in point FCL.825 of Annex I (Part-FCL) to Regulation (EU) No 1178/2011 becomes redundant and therefore it should be deleted. However, the existing EIR holders should be entitled to continue to exercise their privileges and should receive credits from their EIR when they seek to obtain a BIR. It should also be possible to continue an on-going training for an EIR that commenced prior to the application of this Regulation and to complete it as training for a BIR. |
(7) |
Technical update to Regulation (EU) No 1178/2011 should be made on basis of lessons learned in particular in the area of Performance Based Navigation (PBN), Upset Prevention and Recovery Training (UPRT) and instructor and examiner qualifications. |
(8) |
The measures provided for in this Regulation are based on Opinion No 01/2019 (5) of the European Union Aviation Safety Agency in accordance with point (b) of Article 75(2) and Article 76(1) of Regulation (EU) 2018/1139. |
(9) |
The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 127 of Regulation (EU) 2018/1139, |
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) No 1178/2011 is amended as follows:
(1) |
Article 1 is replaced by the following: ‘Article 1 Subject matter 1. This Regulation lays down detailed rules for:
2. Articles 11b and 11c of this Regulation as well as Annex IV (Part-MED), Annex VI (Part-ARA), Annex VII (Part-ORA) and Annex VIII (Part-DTO) to this Regulation shall apply to pilot licences for balloons and sailplanes.’ |
(2) |
in Article 2, paragraph 19 is replaced by the following:
(*1) Commission Regulation (EU) 2018/395 of 13 March 2018 laying down detailed rules for the operation of balloons pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 71, 14.3.2018, p. 10)." (*2) Commission Implementing Regulation (EU) 2018/1976 of 14 December 2018 laying down detailed rules for the operation of sailplanes pursuant to Regulation (EU) 2018/1139 of the European Parliament and of the Council (OJ L 326, 20.12.2018, p. 64).’;" |
(3) |
In article 4, paragraph 8, ‘8 April 2021’ is replaced by ‘8 September 2021’. |
(4) |
the following Article 4c is inserted: ‘Article 4c Transitional measures for holders of an en route instrument rating 1. Up to and including 8 September 2022, holders of an en route instrument rating (‘EIR’) set out in point FCL.825 of Annex I (Part-FCL) shall:
2. As from 8 September 2021, training courses for an EIR referred to in paragraph 1, that have commenced prior to that date, can be continued and shall be regarded as training courses for a BIR. Based on an assessment of the applicant, the approved training organisation responsible for the BIR training course shall determine the amount of EIR training to be credited towards the issue of the BIR. 3. Applicants for a BIR who hold an EIR or have passed the theoretical knowledge examination for an EIR in accordance with point FCL.825(d) prior to 8 September 2021 shall receive full credit towards the requirements for the theoretical knowledge instruction and examination for the BIR. (*3) Commission Delegated Regulation (EU) of 4 March 2020 (not yet published in the Official Journal).’;" |
(5) |
Article 11c is replaced by the following: ‘Article 11c Transitional measures Member States shall:
(*4) Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).’;" |
(6) |
in Article 12, point (2a) is deleted; |
(7) |
in Article 12(4), ‘20 June 2020’ is replaced by ‘20 June 2021’ |
(8) |
Annex I (Part-FCL) is amended in accordance with Annex I to this Regulation; |
(9) |
Annex IV (Part-MED) is amended in accordance with Annex II to this Regulation; |
(10) |
Annex VI (Part-ARA) is amended in accordance with Annex III to this Regulation; |
(11) |
Annex VII (Part-ORA) is amended in accordance with Annex IV to this Regulation; |
(12) |
Annex VIII (Part-DTO) is amended in accordance with Annex V to this Regulation. |
Article 2
1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
2. This Regulation shall apply from 8 April 2020.
3. By way of derogation from paragraph 2, the following provisions shall apply from 8 September 2021:
(a) |
points (1)(e), (4)(b), (5) to (7), (32), (34), (36)(d), (40)(a), (41); (42), (44), (46) to (48), (52)(f), (53)(a) to (53)(c) (53)(e), (53)(f), (54), (55), (56)(a) to (56)(c) and (57) of Annex I; |
(b) |
point (b) of Annex II; |
(c) |
point (10)(d)(ii) of Annex III. |
4. By way of derogation from paragraph 2, Article 1 point (7) and points (49), (53)(d), (58)(b), (58)(d) and (58)(e) of Annex I shall apply from the day of entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 March 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 212, 22.8.2018, p. 1.
(2) Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 311, 25.11.2011, p. 1).
(3) Commission Regulation (EU) 2018/395 of 13 March 2018 laying down detailed rules for the operation of balloons pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 71, 14.3.2018, p. 10).
(4) Commission Implementing Regulation (EU) 2018/1976 of 14 December 2018 laying down detailed rules for the operation of sailplanes pursuant to Regulation (EU) 2018/1139 of the European Parliament and of the Council (OJ L 326, 20.12.2018, p. 64).
(5) Easier access for GA pilots to IFR flying & Revision of the balloon and sailplane licensing requirements, (Opinion No 01/2019 (A) & (B), 19.02.2019), available at: https://www.easa.europa.eu/document-library/opinions
ANNEX I
Annex I (Part-FCL) to Commission Regulation (EU) No 1178/2011 is amended as follows:
(1) |
Point FCL.010 is amended as follows:
|
(2) |
point FCL.015 in amended as follows:
|
(3) |
in point FCL.020, paragraph (b) is replaced by the following:
|
(4) |
point FCL.025(c)(1) is amended as follows:
|
(5) |
in point FCL.030, the following paragraph (c) is added:
|
(6) |
in point FCL.035, paragraph (b) is replaced by the following:
|
(7) |
point FCL.055 is amended as follows:
|
(8) |
point FCL.060 is amended as follows:
|
(9) |
point FCL.065 is amended as follows:
|
(10) |
point FCL.100 is replaced by the following: ‘ FCL.100 LAPL – Minimum age Applicants for the LAPL for aeroplanes or helicopters shall be at least 17 years old.’; |
(11) |
point FCL.120 is replaced by the following: ‘ FCL.120 LAPL – Theoretical knowledge examination Applicants for an LAPL shall demonstrate a level of theoretical knowledge appropriate to the privileges granted, through examinations on the following:
|
(12) |
in point FCL.110.A, paragraph (b) is replaced by the following:
|
(13) |
in point FCL.135.A, the following paragraph (c) is added:
|
(14) |
Sections 4 and 5 of Subpart B are deleted; |
(15) |
the title of Subpart C is replaced by the following: ‘ PRIVATE PILOT LICENCE (PPL) ’; |
(16) |
point FCL.200 is replaced by the following: ‘ FCL.200 Minimum age Applicants for a PPL shall be at least 17 years old.’; |
(17) |
in point FCL.210, paragraphs (a) and (b) are replaced by the following:
|
(18) |
point FCL.215 is replaced by the following: ‘ FCL.215 Theoretical knowledge examination Applicants for a PPL shall demonstrate a level of theoretical knowledge appropriate to the privileges granted through examinations in the following subjects:
|
(19) |
point FCL.235 is amended as follows:
|
(20) |
in point FCL.210.A, paragraph (c) is amended as follows:
|
(21) |
in point FCL.210.As, paragraph (b) is replaced by the following:
|
(22) |
in Subpart C, Sections 5 and 6 are deleted; |
(23) |
point FCL.600 is replaced by the following: ‘ FCL.600 IR – General Except as provided in point FCL.835, operations under IFR on an aeroplane, helicopter, airship or powered-lift aircraft shall be conducted only by holders of a PPL, CPL, MPL and ATPL with an IR appropriate to the category of aircraft or, if an IR appropriate to the category of aircraft is not available, only while undergoing skill testing or dual instruction.’; |
(24) |
in point FCL.620, the following point (c) is added:
|
(25) |
in point FCL.700, paragraph (a) is replaced by the following:
|
(26) |
in point FCL.725, the following paragraph (f) is added:
|
(27) |
point FCL.740.A is amended as follows:
|
(28) |
point FCL.800 is amended as follows:
|
(29) |
point FCL.805 is amended as follows:
|
(30) |
point FCL.810 is amended as follows:
|
(31) |
in point FCL.815, the introductory sentence of paragraph (a) is replaced by the following:
|
(32) |
point FCL.825 is deleted; |
(33) |
point FCL.830 is deleted; |
(34) |
the following point FCL.835 is inserted: ‘ FCL.835 Basic instrument rating (BIR)
|
(35) |
point FCL.915(c)(1) is replaced by the following:
|
(36) |
point FCL.905.FI is amended as follows:
|
(37) |
point FCL.910.FI is amended as follows:
|
(38) |
in point FCL.915.FI, paragraphs (e) and (f) are deleted; |
(39) |
paragraph (b) of point FCL.930.FI is amended as follows:
|
(40) |
paragraph (a) of point FCL.940.FI is amended as follows:
|
(41) |
in point FCL.905.TRI, paragraph (a) is replaced by the following:
|
(42) |
in point FCL.905.IRI, paragraph (a) is replaced by the following:
|
(43) |
point FCL.915.IRI is replaced by the following: ‘ FCL.915.IRI Applicants for an IRI certificate shall:
|
(44) |
in point FCL.905.STI, paragraph (a)(2) is replaced by the following:
|
(45) |
in point FCL.1005.FE, paragraphs (d) and (e) are deleted. |
(46) |
in point FCL.1005.TRE, paragraph (a)(2) is replaced by the following:
|
(47) |
in point FCL.1005.CRE, paragraph (b)(4) is replaced by the following:
|
(48) |
point FCL.1005.IRE is replaced by the following: ‘ FCL.1005.IRE IRE – Privileges The privileges of holders of an instrument rating examiner (IRE) certificate are to conduct skill tests for the issue and proficiency checks for the revalidation or renewal of BIRs and IRs.’; |
(49) |
in point FCL.1010.SFE, paragraphs (a) (1) and (2) are amended as follows:
|
(50) |
in point FCL.1005.FIE, paragraph (c) is amended as follows:
|
(51) |
in point FCL.1010.FIE, paragraphs (d) and (e) are deleted; |
(52) |
Appendix 1 is amended as follows:
|
(53) |
Appendix 3 is amended as follows:
|
(54) |
in Appendix 6, Chapter A is amended as follows:
|
(55) |
in Appendix 6, Chapter Aa is amended as follows:
|
(56) |
Appendix 7 is amended as follows:
|
(57) |
the title of Appendix 9 replaced by ‘Training, skill test and proficiency check for MPL, ATPL, type and class ratings, and proficiency check for the BIR and IR’. |
(58) |
Appendix 9 is amended as follows:
|
ANNEX II
Point MED.A.030 of Annex IV (Part-MED) to Commission Regulation (EU) No 1178/2011 is amended as follows:
(a) |
paragraph (c) is replaced by the following:
|
(b) |
paragraph (e) is replaced by the following:
|
ANNEX III
Annex VI (Part-ARA) to Commission Regulation (EU) No 1178/2011 is amended as follows:
(1) |
in point ARA.GEN.220, paragraph (b) is replaced by the following:
|
(2) |
point ARA.GEN.350 is amended as follows:
|
(3) |
in point ARA.GEN.360, point (a) is replaced by the following:
|
(4) |
in point ARA.FCL.200, the following paragraph (e) is added:
|
(5) |
in point ARA.FCL.250(a), subparagraph (3) is replaced by the following:
|
(6) |
in point ARA.FCL.300, paragraph (a) is replaced by the following:
|
(7) |
the following point ARA.ATO.110 is inserted after point ARA.ATO.105: ‘ ARA.ATO.110 Approval of minimum equipment lists When the competent authority receives an application for approval of a minimum equipment list under points ORO.MLR.105 of Annex III (Part-ORO) and NCC.GEN.101 of Annex VI (Part-NCC) to Regulation (EU) No 965/2012, it shall act in accordance with point ARO.OPS.205 of Annex II (Part-ARO) to that Regulation.’; |
(8) |
in point ARA.DTO.100, paragraph (b) is replaced by the following:
|
(9) |
in point ARA.DTO.110, paragraph (a) is replaced by the following:
|
(10) |
Appendix I is amended as follows:
|
(11) |
Appendix III is replaced by the following: ‘CERTIFICATE FOR APPROVED TRAINING ORGANISATIONS (ATOs) European Union * Competent Authority APPROVED TRAINING ORGANISATION CERTIFICATE [CERTIFICATE NUMBER/REFERENCE] Pursuant to Commission Regulation (EU) No 1178/2011 [and Commission Regulation (EU) 2018/395/Commission Implementing Regulation (EU) 2018/1976 (ADJUST AS APPLICABLE)] and subject to the conditions specified below, the [Competent Authority] hereby certifies [NAME OF THE TRAINING ORGANISATION] [ADDRESS OF THE TRAINING ORGANISATION] as a Part-ORA certified training organisation with the privilege to provide Part-FCL training courses, including the use of FSTDs, as listed in the attached training course approval/Part-BFCL training courses/Part-SFCL training courses [ADJUST AS APPLICABLE]. CONDITIONS: This certificate is limited to the privileges and the scope of providing the training courses, including the use of FSTDs, as listed in the attached training course approval. This certificate is valid whilst the approved organisation remains in compliance with Part-ORA, Part-FCL, Part-BFCL, Part-SFCL [ADJUST AS APPLICABLE] and other applicable regulations. Subject to compliance with the foregoing conditions, this certificate shall remain valid unless it has been surrendered, superseded, limited, suspended or revoked. Date of issue: Signed: [Competent Authority]
EASA FORM 143 Issue 2 – Page 1/2 APPROVED TRAINING ORGANISATION CERTIFICATE TRAINING COURSE APPROVAL Attachment to ATO Certificate Number: [CERTIFICATE NUMBER/REFERENCE] [NAME OF THE TRAINING ORGANISATION] has obtained the privilege to provide and conduct the following Part-FCL/Part-BFCL/Part-SFCL [ADJUST AS APPLICABLE] training courses and to use the following FSTDs:
This training course approval is valid as long as:
Date of issue: Signed: [Competent Authority] For the Member State/EASA EASA FORM 143 Issue 2 – Page 2/2’;
‘ Training programme approval for a declared training organisation (DTO) European Union (*) Competent authority
EASA Form XXX Issue 2 – Page 1/1’. |
(1) as indicated on the qualification certificate
ANNEX IV
Annex VII (Part-ORA) to Commission Regulation (EU) No 1178/2011 is amended as follows:
(1) |
point ORA.ATO.110 is amended as follows:
|
(2) |
in point ORA.ATO.125, paragraph (b) is replaced by the following:
|
ANNEX V
Annex VIII (Part-DTO) to Commission Regulation (EU) No 1178/2011 is amended as follows:
(1) |
point DTO.GEN.110 is amended as follows:
|
(2) |
in point DTO.GEN.115(a), subparagraph (8) is replaced by the following:
|
(3) |
point DTO.GEN.210 is amended as follows:
|
(4) |
point DTO.GEN.230 is amended as follows:
|
(5) |
in Appendix 1, Section 9 of the declaration form is replaced by the following:
|
DIRECTIVES
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/109 |
COMMISSION DELEGATED DIRECTIVE (EU) 2020/360
of 17 December 2019
amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in platinized platinum electrodes used for certain conductivity measurements
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
Whereas:
(1) |
Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications which are specific to medical devices and monitoring and control instruments and are listed in Annex IV to that Directive. |
(2) |
The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive. |
(3) |
Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. |
(4) |
By Delegated Directive 2014/73/EU (2), the Commission granted an exemption for the use of lead in platinized platinum electrodes used for conductivity measurements where certain conditions apply (‘the exemption’), by including the relevant applications in Annex IV to Directive 2011/65/EU. The exemption was to expire on 31 December 2018, in accordance with the third subparagraph of Article 5(2) of that Directive. |
(5) |
The Commission received an application for renewal of the exemption (‘the renewal request’) on 30 June 2017, that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the exemption remains valid until a decision on the renewal request has been adopted. |
(6) |
The evaluation of the renewal request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. |
(7) |
Lead-containing platinized platinum electrodes are used in specialised instruments for measurements which require certain measurement qualities such as wide range, high accuracy, or high reliability for high concentration of acid and alkali. |
(8) |
Due to the lack of reliable alternatives, a substitution or elimination of lead in the applications concerned is currently scientifically and technically impracticable for certain measurement instruments. The renewal of the exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) and thus does not weaken the environmental and health protection afforded by it. |
(9) |
It is, therefore, appropriate to grant the renewal of the exemption. |
(10) |
The exemption should be renewed for the maximum duration of 7 years until 31 December 2025, in accordance with Article 4(3) and the third subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation. |
(11) |
Directive 2011/65/EU should therefore be amended accordingly, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
Article 2
1. Member States shall adopt and publish, by 31 March 2021 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 1 April 2021.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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
This Directive shall enter into force on the twentieth 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, 17 December 2019.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 174, 1.7.2011, p. 88.
(2) Commission Delegated Directive 2014/73/EU of 13 March 2014 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in platinized platinum electrodes used for conductivity measurements (OJ L 148, 20.5.2014, p. 80).
(3) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).
ANNEX
In Annex IV to Directive 2011/65/EU, entry 37 is replaced by the following:
‘37. |
Lead in platinized platinum electrodes used for conductivity measurements where at least one of the following conditions applies:
|
||||||||||||
|
Expires on 31 December 2025.’ |
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/112 |
COMMISSION DELEGATED DIRECTIVE (EU) 2020/361
of 17 December 2019
amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
Whereas:
(1) |
Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to the exempted applications listed in Annex III to Directive 2011/65/EU. |
(2) |
The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive. |
(3) |
Hexavalent chromium is a restricted substance listed in Annex II to Directive 2011/65/EU. |
(4) |
An exemption from the restriction for the use of hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0,75 % by weight in the cooling solution (‘the exemption’) is included in Annex III to Directive 2011/65/EU. For categories 1 to 7 and 10, the exemption was to expire on 21 July 2016 in accordance with the second subparagraph of Article 5(2) of that Directive. |
(5) |
The Commission received an application for renewal of the exemption (‘the renewal request’) on 20 January 2015, that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the exemption remains valid until a decision on the renewal request has been adopted. |
(6) |
The evaluation of the renewal request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The evaluation, taking into account the Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 (2), led to the conclusion that the current exemption with regard to categories 1 to 7 and 10 is to be divided into two sub-entries with wording clearly reflecting the scientific and technical progress as regards to substitution of hexavalent chromium, which differs depending on the type of application. |
(7) |
Hexavalent chromium (Cr(VI)) acts as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators. It is used to create a layer on the interior surface of the steel tubes to protect them from the cooling solution that contains corrosive ammonia. |
(8) |
For applications with power input ≥ 75 W and for systems fully operating with non-electrical heaters (corresponding to high boiler temperature applications) which are covered by the current exemption, a substitution or elimination of hexavalent chromium is still scientifically and technically impracticable due to the lack of reliable substitutes. An exemption for these applications is in line with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) and thus does not weaken the environmental and health protection afforded by it. |
(9) |
It is, therefore, appropriate to grant the requested renewal for applications using high boiler temperatures until 21 July 2021, in accordance with Article 4(3) and the second subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation. |
(10) |
For applications with power input < 75 W (corresponding to low boiler temperature) currently covered by the exemption, the conditions for renewal set out in Article 5(1) of Directive 2011/65/EU are no longer fulfilled and therefore, the renewal request should be rejected. In accordance with Article 5(6) of that Directive, the exemption for those applications should expire 12 months after the date of entry into force of this Directive. |
(11) |
For categories 8, 9 and 11, the existing exemption remains valid as per the validity periods set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU. For reasons of legal clarity, the dates of expiry should be specified in Annex III to that Directive. |
(12) |
Directive 2011/65/EU should therefore be amended accordingly, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
Article 2
1. Member States shall adopt and publish, by 31 March 2021 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 1 April 2021.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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
This Directive shall enter into force on the twentieth 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, 17 December 2019.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 174, 1.7.2011, p. 88.
(2) Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ C 48, 15.2.2017, p. 9).
(3) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).
ANNEX
In Annex III to Directive 2011/65/EU, entry 9 is replaced by the following:
‘9 |
Hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0,75 % by weight in the cooling solution |
Applies to categories 8, 9 and 11 and expires on:
|
||||||
9(a)-I |
Up to 0,75 % hexavalent chromium by weight, used as an anticorrosion agent in the cooling solution of carbon steel cooling systems of absorption refrigerators (including minibars) designed to operate fully or partly with electrical heater, having an average utilised power input < 75 W at constant running conditions |
Applies to categories 1-7 and 10 and expires on 5 March 2021. |
||||||
9(a)-II |
Up to 0,75 % hexavalent chromium by weight, used as an anticorrosion agent in the cooling solution of carbon steel cooling systems of absorption refrigerators:
|
Applies to categories 1-7 and 10 and expires on 21 July 2021.’ |
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/116 |
COMMISSION DELEGATED DIRECTIVE (EU) 2020/362
of 17 December 2019
amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council on end-of-life vehicles as regards the exemption for hexavalent chromium as anti-corrosion agent of the carbon steel cooling system in absorption refrigerators in motor caravans
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles (1), and in particular Article 4(2)(b) thereof,
Whereas:
(1) |
Pursuant to Article 4(2)(a) of Directive 2000/53/EC, Member States are to prohibit the use of lead, mercury, cadmium and hexavalent chromium in materials and components of vehicles put on the market after 1 July 2003. |
(2) |
Annex II to Directive 2000/53/EC lists vehicle materials and components exempt from the prohibition pursuant to Article 4(2)(a) thereof. Exemption 14 regarding the use of hexavalent chromium needs to be amended to align for coherence the wording of that exemption with similar exemptions for the use of hexavalent chromium provided for in Directive 2011/65/EU of the European Parliament and of the Council (2) and Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3). |
(3) |
The assessment of exemption 14 in view of technical and scientific progress led to the conclusion that although suitable alternative substances to hexavalent chromium have become available, they cannot yet be used in products. It is expected that suitable alternatives to the use of hexavalent chromium may become available in the future. It is hence appropriate to split the current exemption in three sub-entries and set an expiry date for two of the sub-entries to the exemption. |
(4) |
Directive 2000/53/EC should therefore be amended accordingly. |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex II to Directive 2000/53/EC is amended as set out in the Annex to this Directive.
Article 2
1. Member States shall adopt and publish by 5 April 2020 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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
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, 17 December 2019.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 269, 21.10.2000, p. 34.
(2) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).
(3) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
ANNEX
In Annex II to Directive 2000/53/EC, entry 14 is replaced by the following:
‘14. Hexavalent chromium as an anti-corrosion agent of the carbon steel cooling system in absorption refrigerators up to 0,75 % by weight in the cooling solution:
|
Vehicles type approved before 1 January 2020 and spare parts for these vehicles Vehicles type approved before 1 January 2026 and spare parts for these vehicles |
X’ |
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/119 |
COMMISSION DELEGATED DIRECTIVE (EU) 2020/363
of 17 December 2019
amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council on end-of-life vehicles as regards certain exemptions for lead and lead compounds in components
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles (1), and in particular Article 4(2)(b) thereof,
Whereas:
(1) |
Pursuant to Article 4(2)(a) of Directive 2000/53/EC, Member States are to prohibit the use of lead, mercury, cadmium and hexavalent chromium in materials and components of vehicles put on the market after 1 July 2003. |
(2) |
Annex II to Directive 2000/53/EC lists vehicle materials and components exempt from the prohibition pursuant to Article 4(2)(a) thereof. Pursuant to Annex II, exemptions 8(e), 8(f)(b) and 8(g) are to be reviewed in 2019. Exemption 8(j) also needs to be re-assessed in view of the latest information on technical and scientific progress. |
(3) |
An assessment of exemptions 8(e) and 8(g) in view of that information led to the conclusion that there are currently no suitable alternatives to the use of lead for the materials and components covered by those exemptions. A date for a new review of those exemptions should therefore be set. Exemption 8(g), however, should be further specified with a more narrow scope. In order to allow the automotive industry to adapt to those changes, the current scope of exemption 8(g) should be maintained for vehicles of a type approved before 1 October 2022, while the narrower scope of that exemption should apply for vehicles of a type approved from that date. |
(4) |
The assessment of exemption 8(f)(b) leads to the conclusion that the use of lead in the applications covered by that exemption should not be prolonged because there are alternatives to the use of lead in those applications. |
(5) |
The assessment of exemption 8(j) which gives an exemption to the use of lead in solders for soldering of laminated glazing led to the conclusion that, for some applications, there are alternatives to the use of lead in solders for soldering of laminated glazing. However, there are some glass panes and applications for which there is no certainty that suitable alternatives to the use of lead exist at this time. It is therefore appropriate to lay down a new, more limited, exemption 8(k) for those glass panes and applications. |
(6) |
Exemption 8(j) applies only with respect to vehicles of a type approved before 1 January 2020. In order to ensure that the use of lead continues to be exempted for those glass panes and applications for which there is no certainty that suitable alternatives to the use of lead exist at this time, it is necessary for the new exemption 8(k) to apply as soon as possible. Therefore, this Directive should enter into force as a matter of urgency. |
(7) |
Directive 2000/53/EC should therefore be amended accordingly, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex II to Directive 2000/53/EC is amended as set out in the Annex to this Directive.
Article 2
1. Member States shall adopt and publish by 5 April 2020 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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
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, 17 December 2019.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX
Annex II to Directive 2000/53/EC is amended as follows:
(1) |
entry 8(e) is replaced by the following:
|
(2) |
entry 8(f)(b) is replaced by the following:
|
(3) |
entry 8(g) is replaced by the following:
|
(4) |
the following entry 8(k) is inserted:
|
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/122 |
COMMISSION DELEGATED DIRECTIVE (EU) 2020/364
of 17 December 2019
amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of cadmium in certain radiation tolerant video camera tubes
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
Whereas:
(1) |
Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications which are specific to medical devices and monitoring and control instruments and are listed in Annex IV to that Directive. |
(2) |
The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive. |
(3) |
Cadmium is a restricted substance listed in Annex II to Directive 2011/65/EU. |
(4) |
On 3 December 2015, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for the use of cadmium in certain radiation tolerant video camera tubes (‘the requested exemption’). |
(5) |
The evaluation of the request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. |
(6) |
Cadmium in video camera tubes is necessary to achieve satisfactory radiation tolerance and optical performance of video cameras operating in environments with high radiation exposure, such as nuclear power plants and nuclear waste reprocessing facilities. |
(7) |
Currently, there are no cadmium-free alternatives available on the market which would provide the necessary combination of optical performance and sufficient radiation resistance. |
(8) |
Due to the lack of alternatives, a substitution or elimination of cadmium is scientifically and technically impracticable for certain video camera tubes. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) and thus does not weaken the environmental and health protection afforded by it. |
(9) |
It is, therefore, appropriate to grant the requested exemption by including the applications covered by it in Annex IV to Directive 2011/65/EU with respect to electrical and electronic equipment of category 9. |
(10) |
The requested exemption should be granted for a duration of 7 years starting from 5 March 2020, in accordance with the first subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation. |
(11) |
Directive 2011/65/EU should therefore be amended accordingly, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
Article 2
1. Member States shall adopt and publish, by 31 August 2020 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 1 September 2020.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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
This Directive shall enter into force on the twentieth 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, 17 December 2019.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 174, 1.7.2011, p. 88.
(2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).
ANNEX
In Annex IV to Directive 2011/65/EU, the following entry 44 is added:
‘44. |
Cadmium in radiation tolerant video camera tubes designed for cameras with a centre resolution greater than 450 TV lines which are used in environments with ionising radiation exposure exceeding 100 Gy/hour and a total dose in excess of 100kGy. |
|
Applies to category 9. Expires on 31 March 2027.’ |
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/125 |
COMMISSION DELEGATED DIRECTIVE (EU) 2020/365
of 17 December 2019
amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders and termination finishes used in certain hand-held combustion engines
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
Whereas:
(1) |
Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to the exempted applications listed in Annex III to Directive 2011/65/EU. |
(2) |
The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive. |
(3) |
Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. |
(4) |
By Delegated Directive (EU) 2014/72/EU (2), the Commission granted an exemption for the use of lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council (3)) (“the exemption”) by including those applications in Annex III to Directive 2011/65/EU. The exemption was to expire for categories 1 to 7 and 10 on 31 December 2018, in accordance with the second subparagraph of Article 5(2) of that Directive. |
(5) |
The Commission received an application for renewal of the exemption for categories 6 and 11 (“the renewal request”) on 30 June 2017, that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the exemption remains valid until a decision on the renewal request has been adopted. |
(6) |
The evaluation of the renewal request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. |
(7) |
Lead is a common alloying element in solder material to control the melting point. Alternative materials to replace the restricted substance have been successfully tested. However, additional time is needed to confirm the reliability of the lead-free products. |
(8) |
Currently, there are no lead-free alternatives available on the market which would provide sufficient level of reliability for the applications covered by the exemption. |
(9) |
Due to the lack of reliable alternatives, a substitution or elimination of lead is currently scientifically and technically impracticable for certain hand-held combustion engines. It is, therefore, appropriate, to renew the exemption. The renewal of the exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4) and thus does not weaken the environmental and health protection afforded by it. |
(10) |
The exemption for categories 1 to 7, 10 and 11 should be renewed until 31 March 2022, in accordance with Article 4(3) and the first subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation. |
(11) |
For categories 8 and 9, the existing exemption remains valid as per the validity periods set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU. For reasons of legal clarity, the dates of expiry should be specified in Annex III to that Directive. |
(12) |
Directive 2011/65/EU should therefore be amended accordingly, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
Article 2
1. Member States shall adopt and publish, by 31 March 2021 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 1 April 2021.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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
This Directive shall enter into force on the twentieth 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, 17 December 2019.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 174, 1.7.2011, p. 88.
(2) Commission Delegated Directive 2014/72/EU of 13 March 2014 amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems (OJ L 148, 20.5.2014, p. 78).
(3) Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1). Directive 97/68/EC has been repealed by Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53).
(4) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).
ANNEX
In Annex III to Directive 2011/65/EU, entry 41 is replaced by the following:
‘41 |
Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council (*1)) |
Applies to all categories and expires on:
|
(*1) Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1).’
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/129 |
COMMISSION DELEGATED DIRECTIVE (EU) 2020/366
of 17 December 2019
amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
Whereas:
(1) |
Article 4(1) of Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications which are specific to medical devices and monitoring and control instruments and are listed in Annex IV to that Directive. |
(2) |
The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive. |
(3) |
Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. |
(4) |
By Delegated Directive (EU) 2015/573 (2), the Commission granted an exemption for the use of lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases (‘the exemption’), by including that application in Annex IV to Directive 2011/65/EU. The exemption was to expire on 31 December 2018, in accordance with the third subparagraph of Article 5(2) of that Directive. |
(5) |
The Commission received an application for renewal of the exemption (‘the renewal request’) on 25 May 2017, that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the exemption remains valid until a decision on the renewal request has been adopted. |
(6) |
The evaluation of the renewal request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. |
(7) |
Lead in the PVC sensor card of concerned in vitro medical devices (blood analysers) enhances sensor performance which is necessary for the optimum performance of the device in terms of analytical reliability claimed in product publications and thus for fulfilment of requirements laid down in Directive 98/79/EC of the European Parliament and of the Council (3). |
(8) |
While lead-free technologies are available on the market for certain analysers of other manufacturers, reliability testing of substitutes for the specific application subject to the current renewal request requires additional time. |
(9) |
Discontinuation of the exemption is expected to avoid a total of 157 kg of lead being placed on the Union market. At the same time, however, it will result in the need to replace the entire diagnostic device, and consequently, is expected to lead to a premature generation of 112 000 kg of waste electrical and electronic equipment. Furthermore, significant socioeconomic impacts on health providers using the devices concerned would be incurred. |
(10) |
The exemption does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council. (4) In light of the restriction process on lead in PVC provided for in Regulation (EC) No 1907/2006, the exemption should be granted for a short validity period of 2 years to ensure full alignment with that Regulation once the relevant restriction process is concluded. |
(11) |
It is, therefore, appropriate to grant the renewal of the exemption. |
(12) |
The exemption concerns category 8 of electrical and electronic equipment to which Directive 2011/65/EU applies and it should be renewed for the duration of 2 years starting from 5 March 2020, in accordance with the third subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation. |
(13) |
Directive 2011/65/EU should therefore be amended accordingly, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
Article 2
1. Member States shall adopt and publish, by 31 March 2021 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 1 April 2021.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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
This Directive shall enter into force on the twentieth 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, 17 December 2019.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 174, 1.7.2011, p. 88.
(2) Commission Delegated Directive (EU) 2015/573 of 30 January 2015 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices (OJ L 94, 10.4.2015, p. 4).
(3) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).
(4) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).
ANNEX
In Annex IV to Directive 2011/65/EU, entry 41 is replaced by the following:
‘41. |
Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases. |
|
Expires on 31 March 2022.’ |
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/132 |
COMMISSION DIRECTIVE (EU) 2020/367
of 4 March 2020
amending Annex III to Directive 2002/49/EC of the European Parliament and of the Council as regards the establishment of assessment methods for harmful effects of environmental noise
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise (1), and in particular Article 12 thereof,
Whereas:
(1) |
Annex III to Directive 2002/49/EC refers to dose-effect relations to be introduced by way of adaptations of that Annex to technical and scientific progress. |
(2) |
At the time of adoption of this Directive, the high quality and statistically significant information that could be used was that of the World Health Organisation (WHO) Environmental Noise Guidelines for the European Region (2), presenting dose-effect relations for harmful effects induced by the exposure to environmental noise. Consequently, the dose-effect relations introduced in Annex III to Directive 2002/49/EC should be based on those guidelines. In particular concerning the statistical significance, the WHO studies were based on representative populations, and the results of these assessment methods are consequently considered relevant when applied to representative populations. |
(3) |
Beyond the dose-effect relations developed in the context of the WHO, other studies might show different health effect sizes and other health effects, in particular concerning effects of road, railway and aircraft noise in local situations in specific countries. The alternative dose-effect relations established therein could be used provided that they are based on high quality and statistically significant studies. |
(4) |
Currently, limited knowledge is available on the harmful effects of industrial noise so that it is not possible to propose a common method for their assessment. Also, country specificities were not assessed in studies and therefore could not be included in this Annex. Likewise, while links between environmental noise and the following harmful effects were found, there is currently no sufficient evidence for determining a common method for the assessment of those harmful effects: stroke, hypertension, diabetes and other metabolic health outcomes, cognitive impairment in children, mental health and wellbeing, hearing impairment, tinnitus, adverse birth outcomes. Finally, while the link between railway noise and aircraft noise to the ischaemic heart disease (IHD) is established, for these two sources the quantification of the increased risk of IHD is premature. |
(5) |
Directive 2002/49/EC should therefore be amended accordingly. |
(6) |
The measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 13 of Directive 2002/49/EC, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex III to Directive 2002/49/EC is replaced by the text in the Annex to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2021 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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
This Directive shall enter into force on the twentieth 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, 4 March 2020.
For the Commission
Virginijus SINKEVIČIUS
Member of the Commission
(1) OJ L 189, 18.7.2002, p. 12.
(2) Environmental Noise Guidelines for the European Region, World Health Organisation 2018, ISBN 978 92 890 5356 3.
ANNEX
‘ANNEX III
ASSESSMENT METHODS FOR HARMFUL EFFECTS
(Referred to in Article 6(3))
1. Set of harmful effects
For the purposes of the assessment of harmful effects the following shall be considered:
— |
ischaemic heart disease (IHD) corresponding to codes BA40 to BA6Z of the international classification ICD-11 established by the World Health Organisation; |
— |
high annoyance (HA); |
— |
high sleep disturbance (HSD). |
2. Calculation of harmful effects
The harmful effects shall be calculated by either of the following:
— |
the relative risk (RR) of a harmful effect defined as
|
— |
the absolute risk (AR) of a harmful effect defined as
|
2.1. IHD
For the calculation of the RR, with respect to the harmful effect of IHD and concerning the incidence rate (i), the following dose-effect relations shall be used:
for road noise.
2.2. HA
For the calculation of the AR, with respect to the harmful effect of HA the following dose-effect relations shall be used:
for road noise; |
for railway noise; |
for aircraft noise. |
2.3. HSD
For the calculation of the AR, with respect to the harmful effect of HSD the following dose-effect relations shall be used:
for road noise; |
for railway noise; |
for aircraft noise. |
3. Assessment of harmful effects
3.1. The exposure of the population shall be assessed independently for each noise source and harmful effect. Where the same people are simultaneously exposed to different noise sources, the harmful effects may -in general- not be cumulated. However, those effects may be compared to assess the relative importance of each noise.
3.2. Assessment for IHD
3.2.1. For IHD in the case of railway and aircraft noise, the population exposed above adequate Lden levels is estimated as subject to an increased risk of IHD, while the exact number N of cases of IHD cannot be calculated.
3.2.2. For IHD in the case of road noise, the proportion of cases of the specific harmful effect in the population exposed to a RR that is calculated to be caused by environmental noise is derived, for the noise source x (road), harmful effect y (IHD) and for the incidence i by:
Where:
— |
PAFx,y is the population attributable fraction, |
— |
the set of j noise bands is made up of single bands spanning over a maximum of 5 dB (e.g.: 50-51 dB, 51-52 dB, 52-53 dB, etc. or 50-54 dB, 55-59 dB, 60-64 dB, etc.), |
— |
pj is the proportion of the overall population P in the area assessed that is exposed to the j-th exposure band, which is associated with a given RR of a specific harmful effect RRj,x,y . The RRj,x,y is calculated using the formulas described in point 2 of this Annex, calculated at the central value of each noise band (e.g.: depending on availability of data, at 50,5 dB for the noise band defined between 50-51 dB, or 52 dB for the noise band 50-54 dB). |
3.2.3. For IHD in the case of road noise, the total number N of cases of IHD (people affected by the harmful effect y; number of attributable cases) due to the source x is then:
Nx,y = PAFx,y,i * Iy * P (Formula 11)
for road.
Where:
— |
PAFx,y,i is calculated for the incidence i, |
— |
Iy is the incidence rate of IHD in the area under assessment, that can be obtained from statistics on health for the region or country where the area is, |
— |
P is the total population of the area under assessment (the sum of the population in the different noise bands). |
3.3. For HA and HSD in the case of road, railway and aircraft noise, the total number N of people affected by the harmful effect y (number of attributable cases) due to the source x, for each combination of noise source x (road, railway or aircraft source) and harmful effect y (HA, HSD), is then:
Where:
— |
ARx,y is the AR of the relevant harmful effect (HA, HSD), and is calculated using the formulas set out in point 2 of this Annex, calculated at the central value of each noise band (e.g.: depending on availability of data, at 50,5 dB for the noise band defined between 50-51 dB, or 52 dB for the noise band 50-54 dB), |
— |
nj is the number of people that is exposed to the j-th exposure band. |
4. Future revisions
The dose-effect relations introduced by future revisions of this Annex will concern in particular:
— |
the relation between annoyance and Lden for industrial noise, |
— |
the relation between sleep disturbance and Lnight for industrial noise. |
If necessary, specific dose-effect relations could be presented for:
— |
dwellings with special insulation against noise as defined in Annex VI, |
— |
dwellings with a quiet façade as defined in Annex VI, |
— |
different climates/different cultures, |
— |
vulnerable groups of the population, |
— |
tonal industrial noise, |
— |
impulsive industrial noise and other special cases. |
DECISIONS
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/137 |
COMMISSION IMPLEMENTING DECISION (EU) 2020/368
of 3 March 2020
approving the plan for the eradication of African swine fever in feral pigs in certain areas of Slovakia
(notified under document C(2020) 1157)
(Only the Slovak text is authentic)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever (1), and in particular the second subparagraph of Article 16(1) thereof,
Whereas:
(1) |
Directive 2002/60/EC lays down the minimum Union measures to be taken for the control of African swine fever, including those to be applied in the event of confirmation of a case of African swine fever in feral pigs. |
(2) |
In addition, Commission Implementing Decision 2014/709/EU (2) lays down animal health control measures in relation to African swine fever in the Member States or areas thereof as listed in the Annex thereto (the Member States concerned), and in all Member States as regards movements of feral pigs and information obligations. The Annex to Implementing Decision 2014/709/EU demarcates and lists certain areas of the Member States concerned, differentiated by the level of risk based on the epidemiological situation as regards that disease, including a list of high risk areas. That Annex has been amended several times to take account of changes in the epidemiological situation in the Union as regards African swine fever that needed to be reflected in that Annex. |
(3) |
In 2019, Slovakia notified the Commission of cases of African swine fever in feral pigs and has duly taken the disease control measures required by Directive 2002/60/EC. |
(4) |
In light of the current epidemiological situation and in accordance with Article 16 of Directive 2002/60/EC, Slovakia submitted to the Commission a plan for the eradication of African swine fever on 27 November 2019 (the eradication plan). |
(5) |
The Annex to Implementing Decision 2014/709/EU was latest amended by Commission Implementing Decision (EU) 2020/46 (3) to take account, inter alia, of the cases of African swine fever in feral pigs in Slovakia and Parts I and II of that Annex now include the infected areas in Slovakia. |
(6) |
The eradication plan submitted by Slovakia has been examined by the Commission and found to comply with the requirements set out in Article 16 of Directive 2002/60/EC. The eradication plan should therefore be approved accordingly. |
(7) |
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS DECISION:
Article 1
The plan submitted by Slovakia on 27 November 2019, in accordance with Article 16(1) of Directive 2002/60/EC, concerning the eradication of African swine fever from the feral pig population in the areas referred to in the Annex to Implementing Decision 2014/709/EU is hereby approved.
Article 2
Slovakia shall bring into force the laws, regulations and administrative provisions required for the implementation of the eradication plan within a period of 30 days from the date of adoption of this Decision.
Article 3
This Decision is addressed to Slovak Republic.
Done at Brussels, 3 March 2020.
For the Commission
Stella KYRIAKIDES
Member of the Commission
(1) OJ L 192, 20.7.2002, p. 27.
(2) Commission Implementing Decision 2014/709/EU of 9 October 2014 concerning animal health control measures relating to African swine fever in certain Member States and repealing Implementing Decision 2014/178/EU (OJ L 295, 11.10.2014, p. 63).
(3) Commission Implementing Decision (EU) 2020/46 of 20 January 2020 amending the Annex to Implementing Decision 2014/709/EU concerning animal health control measures relating to African swine fever in certain Member States (OJ L 16, 21.1.2020, p. 9).
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/139 |
COMMISSION DECISION (EU) 2020/369
of 4 March 2020
conferring the power to issue an external alert on entities representing consumer and trader interests at a Union level pursuant to Regulation (EU) 2017/2394 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (1), and in particular Article 27(2) thereof,
Whereas:
(1) |
Regulation (EU) 2017/2394 lays down provisions for cooperation between competent authorities designated by Member States as responsible for the enforcement of Union laws that protect consumers’ interests. |
(2) |
Article 27(2) of Regulation (EU) 2017/2394 requires the Commission, to confer the power to issue ‘external alerts’ concerning suspected infringements covered by that Regulation on entities representing consumer, and, where appropriate, trader, interests at a Union level. |
(3) |
The entities covered by this Decision operate on a Union level and expressed interest in participating in the external alert mechanism. Those entities have signed up to the Transparency Register and thereby to the Code of Conduct contained in Annex III of the Agreement between the European Parliament and the European Commission on the transparency register for organisations and self-employed individuals engaged in EU policy-making and policy implementation (2). |
(4) |
Regulation (EU) 2017/2394 applies from 17 January 2020. This Decision should therefore apply from the day following that of its publication in the Official Journal of the European Union in order to enable the organisations concerned to participate in the external alert mechanism as soon as possible. |
(5) |
In line with Article 27(2) of Regulation (EU) 2017/2394 Member States were consulted on the entities covered by this Decision, |
HAS ADOPTED THIS DECISION:
Article 1
The power to issue an external alert pursuant to Article 27(2) of Regulation (EU) 2017/2394 shall be conferred on the following entities:
(a) |
the European Consumer Organisation (BEUC), Identification number in the Transparency Register: 9505781573-45; |
(b) |
the Confederation of Family Organisations in the European Union (COFACE), Identification number in the Transparency Register: 93283396780-85; |
(c) |
the European Community of Consumer Co-operatives (EURO COOP), Identification number in the Transparency Register: 3819438251-87. |
Article 2
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 4 March 2020.
For the Commission
The President
Ursula VON DER LEYEN