# Official Journal L 224/2023

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 224 |
| | |
| English edition | Legislation | Volume 6612 September 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 224

English edition

Legislation

Volume 6612 September 2023

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Regulation (EU) 2023/1753 of 11 September 2023 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for pyriproxyfen in or on certain products (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2023/1754 of 11 September 2023 correcting the German language version of Regulation (EU) No 965/2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (
  1
  ) | 16 |
| | * | Commission Implementing Regulation (EU) 2023/1755 of 11 September 2023 renewing the approval of the low-risk active substance fat distillation residues in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 18 |
| | * | Commission Implementing Regulation (EU) 2023/1756 of 11 September 2023 renewing the approval of the low-risk active substance Cydia pomonella granulovirus (CpGV) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 23 |
| | * | Commission Implementing Regulation (EU) 2023/1757 of 11 September 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bensulfuron, chlormequat, chlorotoluron, clomazone, daminozide, deltamethrin, eugenol, fludioxonil, flufenacet, flumetralin, fosthiazate, geraniol, MCPA, MCPB, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride, tebufenpyrad, thymol, and tritosulfuron (
  1
  ) | 28 |
| | * | Commission Implementing Regulation (EU) 2023/1758 of 11 September 2023 granting a Union authorisation for the biocidal product family SALVECO SALVESAFE PRODUCTS in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  ) | 34 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2023/1759 of 11 September 2023 on the harmonised standards for household dishwashers drafted in support of Regulation (EU) 2019/2022 and Delegated Regulation (EU) 2019/2017 | 100 |
| | * | Commission Implementing Decision (EU) 2023/1760 of 11 September 2023 on the recognition of the report including information on the typical greenhouse gas emissions from the cultivation of canola oilseed (rapeseed) in Australia under Article 31(3) and (4) of Directive (EU) 2018/2001 of the European Parliament and of the Council | 105 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Regulation (EU) 2023/1753 of 11 September 2023 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for pyriproxyfen in or on certain products (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2023/1754 of 11 September 2023 correcting the German language version of Regulation (EU) No 965/2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (
  1
  )

1

16

*

Commission Implementing Regulation (EU) 2023/1755 of 11 September 2023 renewing the approval of the low-risk active substance fat distillation residues in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

1

18

*

Commission Implementing Regulation (EU) 2023/1756 of 11 September 2023 renewing the approval of the low-risk active substance Cydia pomonella granulovirus (CpGV) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

Cydia pomonella

1

23

*

Commission Implementing Regulation (EU) 2023/1757 of 11 September 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bensulfuron, chlormequat, chlorotoluron, clomazone, daminozide, deltamethrin, eugenol, fludioxonil, flufenacet, flumetralin, fosthiazate, geraniol, MCPA, MCPB, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride, tebufenpyrad, thymol, and tritosulfuron (
  1
  )

1

28

*

Commission Implementing Regulation (EU) 2023/1758 of 11 September 2023 granting a Union authorisation for the biocidal product family SALVECO SALVESAFE PRODUCTS in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  )

1

34

DECISIONS

*

Commission Implementing Decision (EU) 2023/1759 of 11 September 2023 on the harmonised standards for household dishwashers drafted in support of Regulation (EU) 2019/2022 and Delegated Regulation (EU) 2019/2017

100

*

Commission Implementing Decision (EU) 2023/1760 of 11 September 2023 on the recognition of the report including information on the typical greenhouse gas emissions from the cultivation of canola oilseed (rapeseed) in Australia under Article 31(3) and (4) of Directive (EU) 2018/2001 of the European Parliament and of the Council

105

| | |
| --- | --- |
| | (1)   Text with EEA relevance. |

---

(1)   Text with EEA relevance.

1

| 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. |
| --- | --- |

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

| 12.9.2023 | EN | Official Journal of the European Union | L 224/1 |
| --- | --- | --- | --- |

12.9.2023

EN

Official Journal of the European Union

L 224/1

---

COMMISSION REGULATION (EU) 2023/1753

of 11 September 2023

amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for pyriproxyfen in or on certain products

(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1), point (a), and Article 49(2) thereof,

Whereas:

| (1) | Maximum residue levels (‘MRLs’) for pyriproxyfen were set in Part A of Annex III to Regulation (EC) No 396/2005. |
| --- | --- |

(1)

Maximum residue levels (‘MRLs’) for pyriproxyfen were set in Part A of Annex III to Regulation (EC) No 396/2005.

| (2) | The European Food Safety Authority (‘the Authority’) submitted a reasoned opinion on the review of the existing MRLs for pyriproxyfen (2) in accordance with Article 12(1) of Regulation (EC) No 396/2005. The Authority recommended to lower the existing MRLs for pyriproxyfen on swine/bovine/goat/horse muscle, fat, liver and kidney, as well as in cattle/horse milk to the limit of determination (‘LOD’) in line with the principle of setting MRLs at levels as low as reasonably achievable and based on sufficient supporting data for the current good agricultural practices (‘GAPs’). As there is no risk for consumers, it is appropriate to set the MRL for pyriproxyfen on these products in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. |
| --- | --- |

(2)

The European Food Safety Authority (‘the Authority’) submitted a reasoned opinion on the review of the existing MRLs for pyriproxyfen (2) in accordance with Article 12(1) of Regulation (EC) No 396/2005. The Authority recommended to lower the existing MRLs for pyriproxyfen on swine/bovine/goat/horse muscle, fat, liver and kidney, as well as in cattle/horse milk to the limit of determination (‘LOD’) in line with the principle of setting MRLs at levels as low as reasonably achievable and based on sufficient supporting data for the current good agricultural practices (‘GAPs’). As there is no risk for consumers, it is appropriate to set the MRL for pyriproxyfen on these products in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority.

| (3) | The Authority further concluded that the MRLs for pyriproxyfen on almonds, chestnuts, hazelnuts, pecans, pistachios, walnuts, pine nuts kernels, pome fruits, grapes, table olives, kaki/Japanese persimmons, pineapples, tomatoes, sweet peppers, aubergines, cucurbits with edible peel, and watermelons should be lowered in line with the principle of setting MRLs at levels as low as reasonably achievable and based on the current GAPs and Codex maximum residue limits (‘CXLs’), which are confirmed as being safe for consumers (3). It also concluded that the MRLs for pyriproxyfen on apricots, peaches, plums, strawberries, mangoes, papayas, melons, cotton seeds and tea should be maintained based on the current GAPs and CXLs, which are confirmed as being safe for consumers (4). In addition, the Authority concluded that the MRLs for pyriproxyfen on citrus fruits, cherries and kumquats should be raised based on the current GAPs and CXLs, which are confirmed as being safe for consumers. As the Authority confirmed in an earlier reasoned opinion (5) that the MRL for pyriproxyfen on banana is safe for consumers, that MRL can be maintained. However, as some information was not available, further consideration by risk managers was required. Therefore, while the MRLs for almonds, chestnuts, hazelnuts, pecans, pistachios, walnuts, pine nuts kernels, pome fruits, grapes, table olives, kaki/Japanese persimmons, pineapples, tomatoes, sweet peppers, aubergines, cucurbits with edible peel, watermelons, apricots, peaches, plums, strawberries, mangoes, papayas, melons, cotton seeds, tea, citrus fruits, cherries, kumquats and bananas are considered safe, they will be reviewed. The review will take into account the information available within two years from the publication of this Regulation. As there is no risk for consumers, it is appropriate to set the MRLs for pyriproxyfen on those products in Annex II to Regulation (EC) No 396/2005 at the levels identified by the Authority. |
| --- | --- |

(3)

The Authority further concluded that the MRLs for pyriproxyfen on almonds, chestnuts, hazelnuts, pecans, pistachios, walnuts, pine nuts kernels, pome fruits, grapes, table olives, kaki/Japanese persimmons, pineapples, tomatoes, sweet peppers, aubergines, cucurbits with edible peel, and watermelons should be lowered in line with the principle of setting MRLs at levels as low as reasonably achievable and based on the current GAPs and Codex maximum residue limits (‘CXLs’), which are confirmed as being safe for consumers (3). It also concluded that the MRLs for pyriproxyfen on apricots, peaches, plums, strawberries, mangoes, papayas, melons, cotton seeds and tea should be maintained based on the current GAPs and CXLs, which are confirmed as being safe for consumers (4). In addition, the Authority concluded that the MRLs for pyriproxyfen on citrus fruits, cherries and kumquats should be raised based on the current GAPs and CXLs, which are confirmed as being safe for consumers. As the Authority confirmed in an earlier reasoned opinion (5) that the MRL for pyriproxyfen on banana is safe for consumers, that MRL can be maintained. However, as some information was not available, further consideration by risk managers was required. Therefore, while the MRLs for almonds, chestnuts, hazelnuts, pecans, pistachios, walnuts, pine nuts kernels, pome fruits, grapes, table olives, kaki/Japanese persimmons, pineapples, tomatoes, sweet peppers, aubergines, cucurbits with edible peel, watermelons, apricots, peaches, plums, strawberries, mangoes, papayas, melons, cotton seeds, tea, citrus fruits, cherries, kumquats and bananas are considered safe, they will be reviewed. The review will take into account the information available within two years from the publication of this Regulation. As there is no risk for consumers, it is appropriate to set the MRLs for pyriproxyfen on those products in Annex II to Regulation (EC) No 396/2005 at the levels identified by the Authority.

| (4) | As the Authority identified that no residue trials were available to derive MRL values for pyriproxyfen on macadamias, avocados, granate apples/pomegranates, cherimoyas, potatoes, sweet potatoes and yams, other root and tuber vegetables except sugar beets, bulb vegetables, okra/lady’s fingers, pumpkins, brassica vegetables (excluding brassica roots and brassica baby leaf crops), lettuces and salad plants, spinaches and similar leaves, watercresses, witloofs/Belgian endives, herbs and edible flowers, legume vegetables, stem vegetables, beans (dry), and soyabeans, further consideration by risk managers was required. In the absence of such trials, which are necessary to derive an MRL value, the Commission considers that it is appropriate to set the MRLs for those products at the product specific LODs set out in Annex II to Regulation (EC) No 396/2005. |
| --- | --- |

(4)

As the Authority identified that no residue trials were available to derive MRL values for pyriproxyfen on macadamias, avocados, granate apples/pomegranates, cherimoyas, potatoes, sweet potatoes and yams, other root and tuber vegetables except sugar beets, bulb vegetables, okra/lady’s fingers, pumpkins, brassica vegetables (excluding brassica roots and brassica baby leaf crops), lettuces and salad plants, spinaches and similar leaves, watercresses, witloofs/Belgian endives, herbs and edible flowers, legume vegetables, stem vegetables, beans (dry), and soyabeans, further consideration by risk managers was required. In the absence of such trials, which are necessary to derive an MRL value, the Commission considers that it is appropriate to set the MRLs for those products at the product specific LODs set out in Annex II to Regulation (EC) No 396/2005.

| (5) | The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs. For pyriproxyfen, those laboratories proposed product specific LODs that are analytically achievable. |
| --- | --- |

(5)

The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs. For pyriproxyfen, those laboratories proposed product specific LODs that are analytically achievable.

| (6) | Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. |
| --- | --- |

(6)

Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.

| (7) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| --- | --- |

(7)

Regulation (EC) No 396/2005 should therefore be amended accordingly.

| (8) | To allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been produced in the Union or imported into the Union before the new MRLs become applicable and for which a high level of consumer protection is maintained. This is the case for all products. |
| --- | --- |

(8)

To allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been produced in the Union or imported into the Union before the new MRLs become applicable and for which a high level of consumer protection is maintained. This is the case for all products.

| (9) | A reasonable period should be allowed to elapse before the new MRLs become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the requirements which result from the modification of the MRLs. |
| --- | --- |

(9)

A reasonable period should be allowed to elapse before the new MRLs become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the requirements which result from the modification of the MRLs.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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

Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2

Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 2 April 2024.

Article 3

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 2 April 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 11 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 70, 16.3.2005, p. 1.

1

(2)  European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for pyriproxyfen according to Article 12 of Regulation (EC) No 396/2005; EFSA Journal 2022;20(11):7617.

2

EFSA Journal

(3)  European Food Safety Authority; Scientific support for preparing an EU position in the 51st Session of the Codex Committee on Pesticide Residues (CCPR); EFSA Journal 2019;17(7):5797.

3

EFSA Journal

(4)  European Food Safety Authority; Scientific support for preparing an EU position for the 52nd Session of the Codex Committee on Pesticide Residues (CCPR); EFSA Journal 2021;19(8):6766.

4

EFSA Journal

(5)  European Food Safety Authority; Reasoned Opinion on the modification of the existing maximum residue level for pyriproxyfen in bananas; EFSA Journal 2016;14(2):4387.

5

EFSA Journal

---

ANNEX

Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:

| (1) | in Annex II, the following column for pyriproxyfen is added:


  ‘ANNEX II
  Pesticide residues and maximum residue levels (mg/kg)







  Code number | Groups and examples of individual products to which the MRLs apply (1) | Pyriproxyfen (F) |
| --- | --- | --- | --- |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | |
| 0110000 | Citrus fruits | 0,7 |
| 0110010 | Grapefruits | (+) |
| 0110020 | Oranges | (+) |
| 0110030 | Lemons | (+) |
| 0110040 | Limes | (+) |
| 0110050 | Mandarins | (+) |
| 0110990 | Others (2) | |
| 0120000 | Tree nuts | 0,01
   (*1) |
| 0120010 | Almonds | (+) |
| 0120020 | Brazil nuts | (+) |
| 0120030 | Cashew nuts | (+) |
| 0120040 | Chestnuts | (+) |
| 0120050 | Coconuts | (+) |
| 0120060 | Hazelnuts/cobnuts | (+) |
| 0120070 | Macadamias | |
| 0120080 | Pecans | (+) |
| 0120090 | Pine nut kernels | (+) |
| 0120100 | Pistachios | (+) |
| 0120110 | Walnuts | (+) |
| 0120990 | Others (2) | |
| 0130000 | Pome fruits | |
| 0130010 | Apples | 0,05(+) |
| 0130020 | Pears | 0,01
   (*1)
  (+) |
| 0130030 | Quinces | 0,01
   (*1)
  (+) |
| 0130040 | Medlars | 0,01
   (*1)
  (+) |
| 0130050 | Loquats/Japanese medlars | 0,01
   (*1)
  (+) |
| 0130990 | Others (2) | 0,01
   (*1) |
| 0140000 | Stone fruits | |
| 0140010 | Apricots | 0,4(+) |
| 0140020 | Cherries (sweet) | 1,5(+) |
| 0140030 | Peaches | 0,5(+) |
| 0140040 | Plums | 0,3(+) |
| 0140990 | Others (2) | 0,01
   (*1) |
| 0150000 | Berries and small fruits | |
| 0151000 | (a) | grapes |

(1)

in Annex II, the following column for pyriproxyfen is added:

‘ANNEX II

Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply (1)

Pyriproxyfen (F)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0110000

Citrus fruits

0,7

0110010

Grapefruits

(+)

0110020

Oranges

(+)

0110030

Lemons

(+)

0110040

Limes

(+)

0110050

Mandarins

(+)

0110990

Others (2)

0120000

Tree nuts

0,01
   (*1)

0120010

Almonds

(+)

0120020

Brazil nuts

(+)

0120030

Cashew nuts

(+)

0120040

Chestnuts

(+)

0120050

Coconuts

(+)

0120060

Hazelnuts/cobnuts

(+)

0120070

Macadamias

0120080

Pecans

(+)

0120090

Pine nut kernels

(+)

0120100

Pistachios

(+)

0120110

Walnuts

(+)

0120990

Others (2)

0130000

Pome fruits

0130010

Apples

0,05(+)

0130020

Pears

0,01
   (*1)
  (+)

0130030

Quinces

0,01
   (*1)
  (+)

0130040

Medlars

0,01
   (*1)
  (+)

0130050

Loquats/Japanese medlars

0,01
   (*1)
  (+)

0130990

Others (2)

0,01
   (*1)

0140000

Stone fruits

0140010

Apricots

0,4(+)

0140020

Cherries (sweet)

1,5(+)

0140030

Peaches

0,5(+)

0140040

Plums

0,3(+)

0140990

Others (2)

0,01
   (*1)

0150000

Berries and small fruits

0151000

(a)

grapes

0,01
   (*1)

0151010

Table grapes

(+)

0151020

Wine grapes

(+)

0152000

| (b) | strawberries |
| --- | --- |

(b)

strawberries

0,05(+)

0153000

| (c) | cane fruits |
| --- | --- |

(c)

cane fruits

0,01
   (*1)

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others (2)

0154000

| (d) | other small fruits and berries |
| --- | --- |

(d)

other small fruits and berries

0,01
   (*1)

0154010

Blueberries

0154020

Cranberries

0154030

Currants (black, red and white)

0154040

Gooseberries (green, red and yellow)

0154050

Rose hips

0154060

Mulberries (black and white)

0154070

Azaroles/Mediterranean medlars

0154080

Elderberries

0154990

Others (2)

0160000

Miscellaneous fruitswith

0161000

| (a) | edible peel |
| --- | --- |

(a)

edible peel

0161010

Dates

0,01
   (*1)

0161020

Figs

0,01
   (*1)

0161030

Table olives

0,01
   (*1)
  (+)

0161040

Kumquats

0,5(+)

0161050

Carambolas

0,01
   (*1)

0161060

Kaki/Japanese persimmons

0,01
   (*1)
  (+)

0161070

Jambuls/jambolans

0,01
   (*1)

0161990

Others (2)

0,01
   (*1)

0162000

| (b) | inedible peel, small |
| --- | --- |

(b)

inedible peel, small

0,01
   (*1)

0162010

Kiwi fruits (green, red, yellow)

0162020

Litchis/lychees

0162030

Passionfruits/maracujas

0162040

Prickly pears/cactus fruits

0162050

Star apples/cainitos

0162060

American persimmons/Virginia kaki

0162990

Others (2)

0163000

| (c) | inedible peel, large |
| --- | --- |

(c)

inedible peel, large

0163010

Avocados

0,01
   (*1)

0163020

Bananas

0,7(+)

0163030

Mangoes

0,02
   (*1)
  (+)

0163040

Papayas

0,3(+)

0163050

Granate apples/pomegranates

0,01
   (*1)

0163060

Cherimoyas

0,01
   (*1)

0163070

Guavas

0,01
   (*1)

0163080

Pineapples

0,01
   (*1)
  (+)

0163090

Breadfruits

0,01
   (*1)

0163100

Durians

0,01
   (*1)

0163110

Soursops/guanabanas

0,01
   (*1)

0163990

Others (2)

0,01
   (*1)

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0,01
   (*1)

0211000

| (a) | potatoes |
| --- | --- |

(a)

potatoes

0212000

| (b) | tropical root and tuber vegetables |
| --- | --- |

(b)

tropical root and tuber vegetables

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others (2)

0213000

| (c) | other root and tuber vegetables except sugar beets |
| --- | --- |

(c)

other root and tuber vegetables except sugar beets

0213010

Beetroots

0213020

Carrots

0213030

Celeriacs/turnip rooted celeries

0213040

Horseradishes

0213050

Jerusalem artichokes

0213060

Parsnips

0213070

Parsley roots/Hamburg roots parsley

0213080

Radishes

0213090

Salsifies

0213100

Swedes/rutabagas

0213110

Turnips

0213990

Others (2)

0220000

Bulb vegetables

0,01
   (*1)

0220010

Garlic

0220020

Onions

0220030

Shallots

0220040

Spring onions/green onions and Welsh onions

0220990

Others (2)

0230000

Fruiting vegetables

0231000

| (a) | Solanaceae and Malvaceae |
| --- | --- |

(a)

Solanaceae and Malvaceae

0231010

Tomatoes

0,7(+)

0231020

Sweet peppers/bell peppers

0,6(+)

0231030

Aubergines/eggplants

0,6(+)

0231040

Okra/lady's fingers

0,01
   (*1)

0231990

Others (2)

0,01
   (*1)

0232000

| (b) | cucurbits with edible peel |
| --- | --- |

(b)

cucurbits with edible peel

0,04

0232010

Cucumbers

(+)

0232020

Gherkins

(+)

0232030

Courgettes

(+)

0232990

Others (2)

0233000

| (c) | cucurbits with inedible peel |
| --- | --- |

(c)

cucurbits with inedible peel

0233010

Melons

0,07(+)

0233020

Pumpkins

0,01
   (*1)

0233030

Watermelons

0,02(+)

0233990

Others (2)

0,01
   (*1)

0234000

| (d) | sweet corn |
| --- | --- |

(d)

sweet corn

0,01
   (*1)

0239000

| (e) | other fruiting vegetables |
| --- | --- |

(e)

other fruiting vegetables

0,01
   (*1)

0240000

Brassica vegetables(excluding brassica roots and brassica baby leaf crops)

0,01
   (*1)

0241000

| (a) | flowering brassica |
| --- | --- |

(a)

flowering brassica

0241010

Broccoli

0241020

Cauliflowers

0241990

Others (2)

0242000

| (b) | head brassica |
| --- | --- |

(b)

head brassica

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others (2)

0243000

| (c) | leafy brassica |
| --- | --- |

(c)

leafy brassica

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others (2)

0244000

| (d) | kohlrabies |
| --- | --- |

(d)

kohlrabies

0250000

Leaf vegetables, herbs and edible flowers

0251000

| (a) | lettuces and salad plants |
| --- | --- |

(a)

lettuces and salad plants

0,01
   (*1)

0251010

Lamb's lettuces/corn salads

0251020

Lettuces

0251030

Escaroles/broad-leaved endives

0251040

Cresses and other sprouts and shoots

0251050

Land cresses

0251060

Roman rocket/rucola

0251070

Red mustards

0251080

Baby leaf crops (including brassica species)

0251990

Others (2)

0252000

| (b) | spinaches and similar leaves |
| --- | --- |

(b)

spinaches and similar leaves

0,01
   (*1)

0252010

Spinaches

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others (2)

0253000

| (c) | grape leaves and similar species |
| --- | --- |

(c)

grape leaves and similar species

0,01
   (*1)

0254000

| (d) | watercresses |
| --- | --- |

(d)

watercresses

0,01
   (*1)

0255000

| (e) | witloofs/Belgian endives |
| --- | --- |

(e)

witloofs/Belgian endives

0,01
   (*1)

0256000

| (f) | herbs and edible flowers |
| --- | --- |

(f)

herbs and edible flowers

0,02
   (*1)

0256010

Chervil

0256020

Chives

0256030

Celery leaves

0256040

Parsley

0256050

Sage

0256060

Rosemary

0256070

Thyme

0256080

Basil and edible flowers

0256090

Laurel/bay leaves

0256100

Tarragon

0256990

Others (2)

0260000

Legume vegetables

0,01
   (*1)

0260010

Beans (with pods)

0260020

Beans (without pods)

0260030

Peas (with pods)

0260040

Peas (without pods)

0260050

Lentils

0260990

Others (2)

0270000

Stem vegetables

0,01
   (*1)

0270010

Asparagus

0270020

Cardoons

0270030

Celeries

0270040

Florence fennels

0270050

Globe artichokes

0270060

Leeks

0270070

Rhubarbs

0270080

Bamboo shoots

0270090

Palm hearts

0270990

Others (2)

0280000

Fungi, mosses and lichens

0,01
   (*1)

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,01
   (*1)

0300000

PULSES

0,01
   (*1)

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others (2)

0400000

OILSEEDS AND OIL FRUITS

0401000

Oilseeds

0401010

Linseeds

0,01
   (*1)

0401020

Peanuts/groundnuts

0,01
   (*1)

0401030

Poppy seeds

0,01
   (*1)

0401040

Sesame seeds

0,01
   (*1)

0401050

Sunflower seeds

0,01
   (*1)

0401060

Rapeseeds/canola seeds

0,01
   (*1)

0401070

Soyabeans

0,01
   (*1)

0401080

Mustard seeds

0,01
   (*1)

0401090

Cotton seeds

0,05(+)

0401100

Pumpkin seeds

0,01
   (*1)

0401110

Safflower seeds

0,01
   (*1)

0401120

Borage seeds

0,01
   (*1)

0401130

Gold of pleasure seeds

0,01
   (*1)

0401140

Hemp seeds

0,01
   (*1)

0401150

Castor beans

0,01
   (*1)

0401990

Others (2)

0,01
   (*1)

0402000

Oil fruits

0,01
   (*1)

0402010

Olives for oil production

(+)

0402020

Oil palms kernels

0402030

Oil palms fruits

0402040

Kapok

0402990

Others (2)

0500000

CEREALS

0,01
   (*1)

0500010

Barley

0500020

Buckwheat and other pseudocereals

0500030

Maize/corn

0500040

Common millet/proso millet

0500050

Oat

0500060

Rice

0500070

Rye

0500080

Sorghum

0500090

Wheat

0500990

Others (2)

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0610000

Teas

15(+)

0620000

Coffee beans

0,05 (*1)

0630000

Herbal infusions from

0,05 (*1)

0631000

| (a) | flowers |
| --- | --- |

(a)

flowers

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others (2)

0632000

| (b) | leaves and herbs |
| --- | --- |

(b)

leaves and herbs

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others (2)

0633000

| (c) | roots |
| --- | --- |

(c)

roots

0633010

Valerian

0633020

Ginseng

0633990

Others (2)

0639000

| (d) | any other parts of the plant |
| --- | --- |

(d)

any other parts of the plant

0640000

Cocoa beans

0,05 (*1)

0650000

Carobs/Saint John's breads

0,05 (*1)

0700000

HOPS

0,05 (*1)

0800000

SPICES

0810000

Seed spices

0,05 (*1)

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others (2)

0820000

Fruit spices

0,05 (*1)

0820010

Allspice/pimento

0820020

Sichuan pepper

0820030

Caraway

0820040

Cardamom

0820050

Juniper berry

0820060

Peppercorn (black, green and white)

0820070

Vanilla

0820080

Tamarind

0820990

Others (2)

0830000

Bark spices

0,05 (*1)

0830010

Cinnamon

0830990

Others (2)

0840000

Root and rhizome spices

0840010

Liquorice

0,05 (*1)

0840020

Ginger (10)

0840030

Turmeric/curcuma

0,05 (*1)

0840040

Horseradish (11)

0840990

Others (2)

0,05 (*1)

0850000

Bud spices

0,05 (*1)

0850010

Cloves

0850020

Capers

0850990

Others (2)

0860000

Flower pistil spices

0,05 (*1)

0860010

Saffron

0860990

Others (2)

0870000

Aril spices

0,05 (*1)

0870010

Mace

0870990

Others (2)

0900000

SUGAR PLANTS

0,01
   (*1)

0900010

Sugar beet roots

0900020

Sugar canes

0900030

Chicory roots

0900990

Others (2)

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Commodities from

0,01
   (*1)

1011000

| (a) | swine |
| --- | --- |

(a)

swine

1011010

Muscle

1011020

Fat

1011030

Liver

1011040

Kidney

1011050

Edible offals (other than liver and kidney)

1011990

Others (2)

1012000

| (b) | bovine |
| --- | --- |

(b)

bovine

1012010

Muscle

1012020

Fat

1012030

Liver

1012040

Kidney

1012050

Edible offals (other than liver and kidney)

1012990

Others (2)

1013000

| (c) | sheep |
| --- | --- |

(c)

sheep

1013010

Muscle

1013020

Fat

1013030

Liver

1013040

Kidney

1013050

Edible offals (other than liver and kidney)

1013990

Others (2)

1014000

| d) | goat |
| --- | --- |

d)

goat

1014010

Muscle

1014020

Fat

1014030

Liver

1014040

Kidney

1014050

Edible offals (other than liver and kidney)

1014990

Others (2)

1015000

| (e) | equine |
| --- | --- |

(e)

equine

1015010

Muscle

1015020

Fat

1015030

Liver

1015040

Kidney

1015050

Edible offals (other than liver and kidney)

1015990

Others (2)

1016000

| (f) | poultry |
| --- | --- |

(f)

poultry

1016010

Muscle

1016020

Fat

1016030

Liver

1016040

Kidney

1016050

Edible offals (other than liver and kidney)

1016990

Others (2)

1017000

| (g) | other farmed terrestrial animals |
| --- | --- |

(g)

other farmed terrestrial animals

1017010

Muscle

1017020

Fat

1017030

Liver

1017040

Kidney

1017050

Edible offals (other than liver and kidney)

1017990

Others (2)

1020000

Milk

0,01
   (*1)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others (2)

1030000

Birds eggs

0,01
   (*1)

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others (2)

1040000

Honey and other apiculture products (7)

0,05 (*1)

1050000

Amphibians and Reptiles

0,01
   (*1)

1060000

Terrestrial invertebrate animals

0,01
   (*1)

1070000

Wild terrestrial vertebrate animals

0,01
   (*1)

1100000

PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)

1200000

PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)

1300000

PROCESSED FOOD PRODUCTS (9)

Pyriproxyfen (F)

(F) Fat soluble

The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 12 September 2025, or, if that information is not submitted by that date, the lack of it.

0110010 Grapefruits

0110020 Oranges

0110030 Lemons

0110040 Limes

0110050 Mandarins

0120010 Almonds

0120020 Brazil nuts

0120030 Cashew nuts

0120040 Chestnuts

0120050 Coconuts

0120060 Hazelnuts/cobnuts

0120080 Pecans

0120090 Pine nut kernels

0120100 Pistachios

0120110 Walnuts

0130020 Pears

0130030 Quinces

0130040 Medlars

0130050 Loquats/Japanese medlars

0140010 Apricots

0140030 Peaches

0151010 Table grapes

0151020 Wine grapes

0152000 (b) strawberries

0161030 Table olives

0161040 Kumquats

0161060 Kaki/Japanese persimmons

0163030 Mangoes

0163040 Papayas

0163080 Pineapples

0231010 Tomatoes

0231020 Sweet peppers/bell peppers

0231030 Aubergines/eggplants

0232010 Cucumbers

0232020 Gherkins

0232030 Courgettes

0233010 Melons

0401090 Cotton seeds

0402010 Olives for oil production

0610000 Teas

The European Food Safety Authority identified some information on residue trials and analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 12 September 2025, or, if that information is not submitted by that date, the lack of it.

0130010 Apples

0140020 Cherries (sweet)

0140040 Plums

0163020 Bananas

0233030 Watermelons

| (2) | in Part A of Annex III, the column for pyriproxyfen is deleted. |
| --- | --- |

(2)

in Part A of Annex III, the column for pyriproxyfen is deleted.

---

(*1)  Indicates lower limit of analytical determination

*1

(1)  For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I

1

---

| 12.9.2023 | EN | Official Journal of the European Union | L 224/16 |
| --- | --- | --- | --- |

12.9.2023

EN

Official Journal of the European Union

L 224/16

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1754

of 11 September 2023

correcting the German language version of Regulation (EU) No 965/2012 laying down technical requirements and administrative procedures related to air operations 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 Article 31(1) thereof,

Whereas:

| (1) | The German language version of Commission Regulation (EU) No 965/2012 (2) contains in Part ORO, Subpart FC, Section 1, point ORO.FC.100(c), of Annex III an error that affects the substance of that provision as regards the required licences and ratings. |
| --- | --- |

(1)

The German language version of Commission Regulation (EU) No 965/2012 (2) contains in Part ORO, Subpart FC, Section 1, point ORO.FC.100(c), of Annex III an error that affects the substance of that provision as regards the required licences and ratings.

| (2) | The German language version of Regulation (EU) No 965/2012 should therefore be corrected accordingly. The other language versions are not affected. |
| --- | --- |

(2)

The German language version of Regulation (EU) No 965/2012 should therefore be corrected accordingly. The other language versions are not affected.

| (3) | The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 65(1) of Regulation (EC) No 216/2008 of the European Parliament and of the Council (3), delivered prior to the adoption of Regulation (EU) No 965/2012, |
| --- | --- |

(3)

The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 65(1) of Regulation (EC) No 216/2008 of the European Parliament and of the Council (3), delivered prior to the adoption of Regulation (EU) No 965/2012,

HAS ADOPTED THIS REGULATION:

Article 1

(Does not concern the English language.)

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, 11 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 212, 22.8.2018, p. 1.

1

(2)  Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1).

2

(3)  Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1).

3

---

| 12.9.2023 | EN | Official Journal of the European Union | L 224/18 |
| --- | --- | --- | --- |

12.9.2023

EN

Official Journal of the European Union

L 224/18

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1755

of 11 September 2023

renewing the approval of the low-risk active substance fat distillation residues in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) in conjunction with Article 22(1) thereof,

Whereas:

| (1) | Commission Directive 2008/127/EC (2) included fat distillation residues as an active substance in Annex I to Council Directive 91/414/EEC (3). |
| --- | --- |

(1)

Commission Directive 2008/127/EC (2) included fat distillation residues as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (2) | In accordance with Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
| --- | --- |

(2)

In accordance with Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | The approval of the active substance fat distillation residues, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 December 2024. |
| --- | --- |

(3)

The approval of the active substance fat distillation residues, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 December 2024.

| (4) | An application for the renewal of the approval of the active substance fat distillation residues was submitted to Czechia, the rapporteur Member State, and France, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article. |
| --- | --- |

(4)

An application for the renewal of the approval of the active substance fat distillation residues was submitted to Czechia, the rapporteur Member State, and France, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State. |
| --- | --- |

(5)

The applicant submitted the supplementary dossiers required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State.

| (6) | The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 25 February 2021. In its draft renewal assessment report the rapporteur Member State proposed to renew the approval of fat distillation residues. |
| --- | --- |

(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 25 February 2021. In its draft renewal assessment report the rapporteur Member State proposed to renew the approval of fat distillation residues.

| (7) | The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission. |
| --- | --- |

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

| (8) | On 5 January 2023, the Authority communicated to the Commission its conclusion (6), according to which fat distillation residues can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
| --- | --- |

(8)

On 5 January 2023, the Authority communicated to the Commission its conclusion (6), according to which fat distillation residues can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (9) | The Commission presented a renewal report and a draft Regulation regarding fat distillation residues to the Standing Committee on Plants, Animals, Food and Feed on 22 March 2023 and on 25 May 2023, respectively. |
| --- | --- |

(9)

The Commission presented a renewal report and a draft Regulation regarding fat distillation residues to the Standing Committee on Plants, Animals, Food and Feed on 22 March 2023 and on 25 May 2023, respectively.

| (10) | The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration. |
| --- | --- |

(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration.

| (11) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance fat distillation residues that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
| --- | --- |

(11)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance fat distillation residues that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

| (12) | The Commission further considers that fat distillation residues is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Fat distillation residues is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. |
| --- | --- |

(12)

The Commission further considers that fat distillation residues is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Fat distillation residues is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009.

| (13) | It is therefore appropriate to renew the approval of fat distillation residues as a low-risk active substance. |
| --- | --- |

(13)

It is therefore appropriate to renew the approval of fat distillation residues as a low-risk active substance.

| (14) | In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to set a minimum purity of fat distillation residues and a maximum amount of the impurity nickel in the fat distillation residues as manufactured in order to ensure the safety of the active substance when used in plant protection products. |
| --- | --- |

(14)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to set a minimum purity of fat distillation residues and a maximum amount of the impurity nickel in the fat distillation residues as manufactured in order to ensure the safety of the active substance when used in plant protection products.

| (15) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(15)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (16) | Commission Implementing Regulation (EU) 2023/1446 (7) extended the approval period of fat distillation residues to 15 December 2024 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date. |
| --- | --- |

(16)

Commission Implementing Regulation (EU) 2023/1446 (7) extended the approval period of fat distillation residues to 15 December 2024 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.

| (17) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(17)

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

Renewal of the approval of the active substance

The approval of the active substance fat distillation residues, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II.

Article 3

Entry into force and date of application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

It shall apply from 1 November 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 11 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (OJ L 344, 20.12.2008, p. 89).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

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

4

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

5

(6)  Conclusion on the peer review of the pesticide risk assessment of the active substance fat distillation residues. EFSA Journal doi:10.2903/j.efsa.2023.7811.

6

EFSA Journal

(7)  Commission Implementing Regulation (EU) 2023/1446 of 12 July 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,5-dichlorobenzoic acid methylester, acetic acid, aluminium ammonium sulphate, aluminium phosphide, aluminium silicate, calcium carbide, cymoxanil, dodemorph, ethylene, extract from tea tree, fat distillation residues, fatty acids C7-C20, flonicamid (IKI-220), gibberellic acid, gibberellins, halosulfuron-methyl, hydrolysed proteins, iron sulphate, magnesium phosphide, maltodextrin, metamitron, plant oils/clove oil, plant oils/rape seed oil, plant oils/spear mint oil, pyrethrins, sulcotrione, tebuconazole and urea (OJ L 178, 13.7.2023, p. 1).

7

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Fat distillation residues
  CAS No not available
  915 (CIPAC No) | Not available | ≥ 400 g/kg of cleaved fatty acids (free/ester bonded)
  palmitic acid min 19 % of cleaved fatty acids
  stearic acid min 18 % of cleaved fatty acids
  oleic acid min 37 % of cleaved fatty acids
  acid value min 70 mg KOH/g
  The following impurity is of toxicological concern and shall not exceed the following levels in the technical material:
  nickel max 0,1 g/kg | 1 November 2023 | 31 October 2038 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fat distillation residues, and in particular Appendices I and II thereof, shall be taken into account.
  Conditions of use shall include risk mitigation measures, where appropriate. |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Fat distillation residues

CAS No not available

915 (CIPAC No)

Not available

≥ 400 g/kg of cleaved fatty acids (free/ester bonded)

palmitic acid min 19 % of cleaved fatty acids

stearic acid min 18 % of cleaved fatty acids

oleic acid min 37 % of cleaved fatty acids

acid value min 70 mg KOH/g

The following impurity is of toxicological concern and shall not exceed the following levels in the technical material:

nickel max 0,1 g/kg

1 November 2023

31 October 2038

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fat distillation residues, and in particular Appendices I and II thereof, shall be taken into account.

Conditions of use shall include risk mitigation measures, where appropriate.

---

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

---

ANNEX II

The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in Part A, entry 229 on fat distillation residues is deleted; |
| --- | --- |

(1)

in Part A, entry 229 on fat distillation residues is deleted;

| (2) | in Part D, the following entry is added:











  No. | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘44 | Fat distillation residues
  CAS No not available
  915 (CIPAC No) | Not available | ≥ 400 g/kg of cleaved fatty acids (free/ester bonded)
  palmitic acid min 19 % of cleaved fatty acids
  stearic acid min 18 % of cleaved fatty acids
  oleic acid min 37 % of cleaved fatty acids
  acid value min 70 mg KOH/g
  The following impurity is of toxicological concern and shall not exceed the following levels in the technical material:
  nickel max 0,1 g/kg | 1 November 2023 | 31 October 2038 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fat distillation residues, and in particular Appendices I and II thereof, shall be taken into account.
  Conditions of use shall include risk mitigation measures, where appropriate. |

(2)

in Part D, the following entry is added:

No.

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘44

Fat distillation residues

CAS No not available

915 (CIPAC No)

Not available

≥ 400 g/kg of cleaved fatty acids (free/ester bonded)

palmitic acid min 19 % of cleaved fatty acids

stearic acid min 18 % of cleaved fatty acids

oleic acid min 37 % of cleaved fatty acids

acid value min 70 mg KOH/g

The following impurity is of toxicological concern and shall not exceed the following levels in the technical material:

nickel max 0,1 g/kg

1 November 2023

31 October 2038

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fat distillation residues, and in particular Appendices I and II thereof, shall be taken into account.

Conditions of use shall include risk mitigation measures, where appropriate.

---

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

---

| 12.9.2023 | EN | Official Journal of the European Union | L 224/23 |
| --- | --- | --- | --- |

12.9.2023

EN

Official Journal of the European Union

L 224/23

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1756

of 11 September 2023

renewing the approval of the low-risk active substance Cydia pomonella granulovirus (CpGV) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) in conjunction with Article 22(1) thereof,

Whereas:

| (1) | Commission Directive 2008/113/EC (2) included Cydia pomonella granulovirus (CpGV) as an active substance in Annex I to Council Directive 91/414/EEC (3). |
| --- | --- |

(1)

Commission Directive 2008/113/EC (2) included Cydia pomonella granulovirus (CpGV) as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (2) | Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
| --- | --- |

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | The approval of the active substance Cydia pomonella granulovirus (CpGV), as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 August 2024. |
| --- | --- |

(3)

The approval of the active substance Cydia pomonella granulovirus (CpGV), as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 August 2024.

| (4) | An application for the renewal of the approval of the active substance Cydia pomonella granulovirus (CpGV) was submitted to Germany, the rapporteur Member State, and the Netherlands, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article. |
| --- | --- |

(4)

An application for the renewal of the approval of the active substance Cydia pomonella granulovirus (CpGV) was submitted to Germany, the rapporteur Member State, and the Netherlands, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State. |
| --- | --- |

(5)

The applicant submitted the supplementary dossiers required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State.

| (6) | The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 16 October 2020. In its draft renewal assessment report the rapporteur Member State proposed to renew the approval of Cydia pomonella granulovirus (CpGV). |
| --- | --- |

(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 16 October 2020. In its draft renewal assessment report the rapporteur Member State proposed to renew the approval of Cydia pomonella granulovirus (CpGV).

| (7) | The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission. |
| --- | --- |

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

| (8) | On 4 October 2022, the Authority communicated to the Commission its conclusion (6) which indicated Cydia pomonella granulovirus (CpGV) can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
| --- | --- |

(8)

On 4 October 2022, the Authority communicated to the Commission its conclusion (6) which indicated Cydia pomonella granulovirus (CpGV) can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (9) | The Commission presented a renewal report and a draft of this Regulation regarding Cydia pomonella granulovirus (CpGV) to the Standing Committee on Plants, Animals, Food and Feed on 22 March 2023 and on 24 May 2023, respectively. |
| --- | --- |

(9)

The Commission presented a renewal report and a draft of this Regulation regarding Cydia pomonella granulovirus (CpGV) to the Standing Committee on Plants, Animals, Food and Feed on 22 March 2023 and on 24 May 2023, respectively.

| (10) | The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration. |
| --- | --- |

(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration.

| (11) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance Cydia pomonella granulovirus (CpGV) that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
| --- | --- |

(11)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance Cydia pomonella granulovirus (CpGV) that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

| (12) | The Commission further considers that Cydia pomonella granulovirus (CpGV) is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Cydia pomonella granulovirus (CpGV) fulfils the conditions set out in point 5 of Annex II to Regulation (EC) No 1107/2009 as it belongs to the Baculoviridae family and has not demonstrated adverse effects on any non-target insects. |
| --- | --- |

(12)

The Commission further considers that Cydia pomonella granulovirus (CpGV) is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Cydia pomonella granulovirus (CpGV) fulfils the conditions set out in point 5 of Annex II to Regulation (EC) No 1107/2009 as it belongs to the Baculoviridae family and has not demonstrated adverse effects on any non-target insects.

| (13) | It is therefore appropriate to renew the approval of Cydia pomonella granulovirus (CpGV) as a low-risk substance. |
| --- | --- |

(13)

It is therefore appropriate to renew the approval of Cydia pomonella granulovirus (CpGV) as a low-risk substance.

| (14) | In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof, and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to provide for certain conditions in order to ensure the fulfilment of the limits on relevant microbiological contamination and the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. |
| --- | --- |

(14)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof, and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to provide for certain conditions in order to ensure the fulfilment of the limits on relevant microbiological contamination and the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers.

| (15) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(15)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (16) | Commission Implementing Regulation (EU) 2023/689 (7) extended the approval period of Cydia pomonella granulovirus (CpGV) to 15 August 2024 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date. |
| --- | --- |

(16)

Commission Implementing Regulation (EU) 2023/689 (7) extended the approval period of Cydia pomonella granulovirus (CpGV) to 15 August 2024 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.

| (17) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(17)

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

Renewal of the approval of the active substance

The approval of the active substance Cydia pomonella granulovirus (CpGV), as specified in Annex I, is renewed, subject to the conditions laid down in that Annex.

Cydia pomonella

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

It shall apply from 1 November 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 11 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Commission Directive 2008/113/EC of 8 December 2008 amending Council Directive 91/414/EEC to include several micro-organisms as active substances (OJ L 330, 9.12.2008, p. 6).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

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

4

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

5

(6)  EFSA (European Food Safety Authority), 2022. Peer review of the pesticide risk assessment of the active substance Cydia pomonella granulovirus (CpGV), EFSA Journal 2022;20(11):7630. Available online: www.efsa.europa.eu.

6

Cydia pomonella

EFSA Journal

(7)  Commission Implementing Regulation (EU) 2023/689 of 20 March 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, malathion, mepanipyrim, metconazole, metrafenone, pirimicarb, pyridaben, pyrimethanil, rimsulfuron, spinosad, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strain T11, Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (OJ L 91, 29.3.2023, p. 1).

7

Bacillus subtilis

Bacillus thuringiensis

Bacillus thuringiensis

Bacillus thuringiensis

Beauveria bassiana

Granulovirus

Trichoderma asperellum

T. harzianum

Trichoderma a

T. harzianum

Trichoderma gamsii

T. viride

Trichoderma harzianum

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Cydia pomonella granulovirus (CpGV) | Not applicable | Bacillus cereus: < 1×107 CFU/g in the formulated products. | 1 November 2023 | 31 October 2038 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Cydia pomonella granulovirus (CpGV), and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (2), |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Cydia pomonella granulovirus (CpGV)

Not applicable

Bacillus cereus: < 1×107 CFU/g in the formulated products.

1 November 2023

31 October 2038

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Cydia pomonella granulovirus (CpGV), and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (2),

| — | the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. |
| --- | --- |

—

the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use.

Conditions of use shall include risk mitigation measures, where appropriate.

---

(1)  Further details on identity and specification of active substance are provided in the Review Report PLAN/2023/240.

(2)  https://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf.

---

ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in Part A, entry 198 on Cydia pomonella granulovirus (CpGV) is deleted; |
| --- | --- |

(1)

in Part A, entry 198 on Cydia pomonella granulovirus (CpGV) is deleted;

| (2) | in Part D, the following entry is added:











  No | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘45 | Cydia pomonella granulovirus (CpGV) | Not applicable | Bacillus cereus: < 1 × 107 CFU/g in the formulated products. | 1 November 2023 | 31 October 2038 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Cydia pomonella granulovirus (CpGV), and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (2), |

(2)

in Part D, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘45

Cydia pomonella granulovirus (CpGV)

Not applicable

Bacillus cereus: < 1 × 107 CFU/g in the formulated products.

1 November 2023

31 October 2038

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Cydia pomonella granulovirus (CpGV), and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (2),

| — | the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. |
| --- | --- |

—

the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use.

Conditions of use shall include risk mitigation measures, where appropriate.

---

(1)  Further details on identity and specification of active substance are provided in the Review Report PLAN/2023/240.

(2)  https://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf’.

---

| 12.9.2023 | EN | Official Journal of the European Union | L 224/28 |
| --- | --- | --- | --- |

12.9.2023

EN

Official Journal of the European Union

L 224/28

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1757

of 11 September 2023

amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bensulfuron, chlormequat, chlorotoluron, clomazone, daminozide, deltamethrin, eugenol, fludioxonil, flufenacet, flumetralin, fosthiazate, geraniol, MCPA, MCPB, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride, tebufenpyrad, thymol, and tritosulfuron

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 17, first paragraph, thereof,

Whereas:

| (1) | According to Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Council Directive 91/414/EEC (2) are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). Active substances approved under Regulation (EC) No 1107/2009 are listed in Part B of the Annex to Implementing Regulation (EU) No 540/2011, and active substances approved under Regulation (EC) No 1107/2009 as candidates for substitution are listed in Part E of that Annex. |
| --- | --- |

(1)

According to Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Council Directive 91/414/EEC (2) are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). Active substances approved under Regulation (EC) No 1107/2009 are listed in Part B of the Annex to Implementing Regulation (EU) No 540/2011, and active substances approved under Regulation (EC) No 1107/2009 as candidates for substitution are listed in Part E of that Annex.

| (2) | The active substances bensulfuron, chlormequat, chlorotoluron, clomazone, daminozide, deltamethrin, fludioxonil, flufenacet, fosthiazate, MCPA, MCPB, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride, tebufenpyrad and tritosulfuron are listed in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The active substances eugenol, geraniol and thymol are listed in Part B and the active substance flumetralin in Part E of that Annex. |
| --- | --- |

(2)

The active substances bensulfuron, chlormequat, chlorotoluron, clomazone, daminozide, deltamethrin, fludioxonil, flufenacet, fosthiazate, MCPA, MCPB, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride, tebufenpyrad and tritosulfuron are listed in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The active substances eugenol, geraniol and thymol are listed in Part B and the active substance flumetralin in Part E of that Annex.

| (3) | Commission Implementing Regulation (EU) 2022/1480 (4) extended the approval period of the active substances bensulfuron, chlorotoluron, clomazone, daminozide, deltamethrin, fludioxonil, flufenacet, fosthiazate, MCPA, MCPB, prosulfocarb, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, and tebufenpyrad until 31 October 2023, of the active substances chlormequat, propaquizafop, quizalofop-P-ethyl, quizalofop-P-tefuryl and tritosulfuron until 30 November 2023 and of the active substance flumetralin until 11 December 2023. |
| --- | --- |

(3)

Commission Implementing Regulation (EU) 2022/1480 (4) extended the approval period of the active substances bensulfuron, chlorotoluron, clomazone, daminozide, deltamethrin, fludioxonil, flufenacet, fosthiazate, MCPA, MCPB, prosulfocarb, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, and tebufenpyrad until 31 October 2023, of the active substances chlormequat, propaquizafop, quizalofop-P-ethyl, quizalofop-P-tefuryl and tritosulfuron until 30 November 2023 and of the active substance flumetralin until 11 December 2023.

| (4) | Commission Implementing Regulation (EU) 2018/184 (5) extended the approval period of the active substance sulfuryl fluoride until 31 October 2023. |
| --- | --- |

(4)

Commission Implementing Regulation (EU) 2018/184 (5) extended the approval period of the active substance sulfuryl fluoride until 31 October 2023.

| (5) | The approval of the active substance eugenol is set to expire on 30 November 2023 in accordance with Commission Implementing Regulation (EU) No 546/2013 (6). |
| --- | --- |

(5)

The approval of the active substance eugenol is set to expire on 30 November 2023 in accordance with Commission Implementing Regulation (EU) No 546/2013 (6).

| (6) | The approval of the active substance geraniol is set to expire on 30 November 2023 in accordance with Commission Implementing Regulation (EU) No 570/2013 (7). |
| --- | --- |

(6)

The approval of the active substance geraniol is set to expire on 30 November 2023 in accordance with Commission Implementing Regulation (EU) No 570/2013 (7).

| (7) | The approval of the active substance thymol is set to expire on 30 November 2023 in accordance with Commission Implementing Regulation (EU) No 568/2013 (8). |
| --- | --- |

(7)

The approval of the active substance thymol is set to expire on 30 November 2023 in accordance with Commission Implementing Regulation (EU) No 568/2013 (8).

| (8) | Applications and supplementary dossiers for the renewal of the approval of each of those active substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (9). All of these applications were declared admissible by the respective rapporteur Member States. |
| --- | --- |

(8)

Applications and supplementary dossiers for the renewal of the approval of each of those active substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (9). All of these applications were declared admissible by the respective rapporteur Member States.

| (9) | For the active substances chlormequat, eugenol, flumetralin, fosthiazate, geraniol, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride, tebufenpyrad and thymol, the risk assessment pursuant to Article 11 of Implementing Regulation (EU) No 844/2012 has not yet been finalised by the respective rapporteur Member States. |
| --- | --- |

(9)

For the active substances chlormequat, eugenol, flumetralin, fosthiazate, geraniol, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride, tebufenpyrad and thymol, the risk assessment pursuant to Article 11 of Implementing Regulation (EU) No 844/2012 has not yet been finalised by the respective rapporteur Member States.

| (10) | For the active substances bensulfuron, chlorotoluron, deltamethrin, MCPA and MCPB, the European Food Safety Authority (‘the Authority’) needs additional time to reach a conclusion requiring, where appropriate, a consultation of experts. Furthermore, additional time is needed for the Commission to adopt the ensuing risk management decision. |
| --- | --- |

(10)

For the active substances bensulfuron, chlorotoluron, deltamethrin, MCPA and MCPB, the European Food Safety Authority (‘the Authority’) needs additional time to reach a conclusion requiring, where appropriate, a consultation of experts. Furthermore, additional time is needed for the Commission to adopt the ensuing risk management decision.

| (11) | For the active substances clomazone, daminozide, fludioxonil, flufenacet and tritosulfuron, additional information for the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, was requested by the Authority pursuant to Article 13(3a), first subparagraph, of Implementing Regulation (EU) No 844/2012 and was submitted by the applicants within the period set by the Authority. However, additional time is needed for the Authority to evaluate the information received and adopt a conclusion on whether the active substances can be expected to meet the approval criteria and for the Commission to adopt the ensuing risk management decision. |
| --- | --- |

(11)

For the active substances clomazone, daminozide, fludioxonil, flufenacet and tritosulfuron, additional information for the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, was requested by the Authority pursuant to Article 13(3a), first subparagraph, of Implementing Regulation (EU) No 844/2012 and was submitted by the applicants within the period set by the Authority. However, additional time is needed for the Authority to evaluate the information received and adopt a conclusion on whether the active substances can be expected to meet the approval criteria and for the Commission to adopt the ensuing risk management decision.

| (12) | Given that it is likely that no decision on the renewal of the approval of these active substances can be taken before the expiry of their respective approval periods on 31 October 2023, 30 November 2023 and 11 December 2023, and that the reasons for the delays in the renewal procedures are beyond the control of the respective applicants, the approval periods of the active substances should be extended in order to enable the completion of the assessments required and finalise the regulatory decision-making procedures on the respective applications for renewal of approval. |
| --- | --- |

(12)

Given that it is likely that no decision on the renewal of the approval of these active substances can be taken before the expiry of their respective approval periods on 31 October 2023, 30 November 2023 and 11 December 2023, and that the reasons for the delays in the renewal procedures are beyond the control of the respective applicants, the approval periods of the active substances should be extended in order to enable the completion of the assessments required and finalise the regulatory decision-making procedures on the respective applications for renewal of approval.

| (13) | As the risk assessment has not yet been finalised by the rapporteur Member States, and in light of the time required to complete the remaining steps in each renewal procedure, the duration of the extension for the active substances chlormequat, fosthiazate, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride and tebufenpyrad should be set at thirty-nine months and for the active substances eugenol, flumetralin, geraniol and thymol should be set at twenty-nine months. |
| --- | --- |

(13)

As the risk assessment has not yet been finalised by the rapporteur Member States, and in light of the time required to complete the remaining steps in each renewal procedure, the duration of the extension for the active substances chlormequat, fosthiazate, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride and tebufenpyrad should be set at thirty-nine months and for the active substances eugenol, flumetralin, geraniol and thymol should be set at twenty-nine months.

| (14) | As the Authority needs additional time to reach a conclusion on the risk assessment for the active substances bensulfuron, chlorotoluron, deltamethrin, MCPA and MCPB requiring, where appropriate, a consultation of experts, the duration of the extension for those active substances should be set at thirty-three months and a half. |
| --- | --- |

(14)

As the Authority needs additional time to reach a conclusion on the risk assessment for the active substances bensulfuron, chlorotoluron, deltamethrin, MCPA and MCPB requiring, where appropriate, a consultation of experts, the duration of the extension for those active substances should be set at thirty-three months and a half.

| (15) | As the Authority requested additional information for the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, the duration of the extension for the active substance daminozide should be set at twenty-two months and a half and, as additional time is needed for its evaluation, the duration of the extension for the active substances clomazone, fludioxonil, flufenacet and tritosulfuron should be set at nineteen months and a half. |
| --- | --- |

(15)

As the Authority requested additional information for the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, the duration of the extension for the active substance daminozide should be set at twenty-two months and a half and, as additional time is needed for its evaluation, the duration of the extension for the active substances clomazone, fludioxonil, flufenacet and tritosulfuron should be set at nineteen months and a half.

| (16) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(16)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (17) | In case the Commission adopts a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed, the Commission will set the expiry date at the same date as it stood before the adoption of this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of the approval of an active substance referred to in the Annex to this Regulation, the Commission will set, as appropriate under the circumstances, the earliest possible application date. |
| --- | --- |

(17)

In case the Commission adopts a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed, the Commission will set the expiry date at the same date as it stood before the adoption of this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of the approval of an active substance referred to in the Annex to this Regulation, the Commission will set, as appropriate under the circumstances, the earliest possible application date.

| (18) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(18)

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

The Annex to Implementing Regulation (EU) No 540/2011 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, 11 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

2

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

3

(4)  Commission Implementing Regulation (EU) 2022/1480 of 7 September 2022 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2-phenylphenol (including its salts such as the sodium salt), 8-hydroxyquinoline, amidosulfuron, bensulfuron, bifenox, chlormequat, chlorotoluron, clofentezine, clomazone, daminozide, deltamethrin, dicamba, difenoconazole, diflufenican, dimethachlor, esfenvalerate, etofenprox, fenoxaprop-P, fenpropidin, fenpyrazamine, fludioxonil, flufenacet, flumetralin, fosthiazate, lenacil, MCPA, MCPB, nicosulfuron, paraffin oils, paraffin oil, penconazole, picloram, prohexadione, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulphur, tebufenpyrad, tetraconazole, tri-allate, triflusulfuron and tritosulfuron (OJ L 233, 8.9.2022, p. 43).

4

(5)  Commission Implementing Regulation (EU) 2018/184 of 7 February 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances FEN 560 (also called fenugreek or fenugreek seed powder) and sulfuryl fluoride (OJ L 34, 8.2.2018, p. 10).

5

(6)  Commission Implementing Regulation (EU) No 546/2013 of 14 June 2013 approving the active substance eugenol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 163, 15.6.2013, p. 17).

6

(7)  Commission Implementing Regulation (EU) No 570/2013 of 17 June 2013 approving the active substance geraniol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (OJ L 168, 20.6.2013, p. 18).

7

(8)  Commission Implementing Regulation (EU) No 568/2013 of 18 June 2013 approving the active substance thymol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 167, 19.6.2013, p. 33).

8

(9)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26), which continues to apply to the procedure for the renewal of the approval of those active substances pursuant to Article 17 of Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012 (OJ L 392, 23.11.2020, p. 20).

9

---

ANNEX

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

1.

| (1) | in the sixth column, expiration of approval, of row 40, Deltamethrin, the date is replaced by ‘15 August 2026’; |
| --- | --- |

(1)

in the sixth column, expiration of approval, of row 40, Deltamethrin, the date is replaced by ‘15 August 2026’;

| (2) | in the sixth column, expiration of approval, of row 65, Flufenacet, the date is replaced by ‘15 June 2025’; |
| --- | --- |

(2)

in the sixth column, expiration of approval, of row 65, Flufenacet, the date is replaced by ‘15 June 2025’;

| (3) | in the sixth column, expiration of approval, of row 69, Fosthiazate, the date is replaced by ‘31 January 2027’; |
| --- | --- |

(3)

in the sixth column, expiration of approval, of row 69, Fosthiazate, the date is replaced by ‘31 January 2027’;

| (4) | in the sixth column, expiration of approval, of row 102, Chlorotoluron, the date is replaced by ‘15 August 2026’; |
| --- | --- |

(4)

in the sixth column, expiration of approval, of row 102, Chlorotoluron, the date is replaced by ‘15 August 2026’;

| (5) | in the sixth column, expiration of approval, of row 104, Daminozide, the date is replaced by ‘15 September 2025’; |
| --- | --- |

(5)

in the sixth column, expiration of approval, of row 104, Daminozide, the date is replaced by ‘15 September 2025’;

| (6) | in the sixth column, expiration of approval, of row 107, MCPA, the date is replaced by ‘15 August 2026’; |
| --- | --- |

(6)

in the sixth column, expiration of approval, of row 107, MCPA, the date is replaced by ‘15 August 2026’;

| (7) | in the sixth column, expiration of approval, of row 108, MCPB, the date is replaced by ‘15 August 2026’; |
| --- | --- |

(7)

in the sixth column, expiration of approval, of row 108, MCPB, the date is replaced by ‘15 August 2026’;

| (8) | in the sixth column, expiration of approval, of row 160, Prosulfocarb, the date is replaced by ‘31 January 2027’; |
| --- | --- |

(8)

in the sixth column, expiration of approval, of row 160, Prosulfocarb, the date is replaced by ‘31 January 2027’;

| (9) | in the sixth column, expiration of approval, of row 161, Fludioxonil, the date is replaced by ‘15 June 2025’; |
| --- | --- |

(9)

in the sixth column, expiration of approval, of row 161, Fludioxonil, the date is replaced by ‘15 June 2025’;

| (10) | in the sixth column, expiration of approval, of row 162, Clomazone, the date is replaced by ‘15 June 2025’; |
| --- | --- |

(10)

in the sixth column, expiration of approval, of row 162, Clomazone, the date is replaced by ‘15 June 2025’;

| (11) | in the sixth column, expiration of approval, of row 186, Tritosulfuron, the date is replaced by ‘15 July 2025’; |
| --- | --- |

(11)

in the sixth column, expiration of approval, of row 186, Tritosulfuron, the date is replaced by ‘15 July 2025’;

| (12) | in the sixth column, expiration of approval, of row 271, Bensulfuron, the date is replaced by ‘15 August 2026’; |
| --- | --- |

(12)

in the sixth column, expiration of approval, of row 271, Bensulfuron, the date is replaced by ‘15 August 2026’;

| (13) | in the sixth column, expiration of approval, of row 272, Sodium 5-nitroguaiacolate, the date is replaced by ‘31 January 2027’; |
| --- | --- |

(13)

in the sixth column, expiration of approval, of row 272, Sodium 5-nitroguaiacolate, the date is replaced by ‘31 January 2027’;

| (14) | in the sixth column, expiration of approval, of row 273, Sodium o-nitrophenolate, the date is replaced by ‘31 January 2027’; |
| --- | --- |

(14)

in the sixth column, expiration of approval, of row 273, Sodium o-nitrophenolate, the date is replaced by ‘31 January 2027’;

| (15) | in the sixth column, expiration of approval, of row 274, Sodium p-nitrophenolate, the date is replaced by ‘31 January 2027’; |
| --- | --- |

(15)

in the sixth column, expiration of approval, of row 274, Sodium p-nitrophenolate, the date is replaced by ‘31 January 2027’;

| (16) | in the sixth column, expiration of approval, of row 275, Tebufenpyrad, the date is replaced by ‘31 January 2027’; |
| --- | --- |

(16)

in the sixth column, expiration of approval, of row 275, Tebufenpyrad, the date is replaced by ‘31 January 2027’;

| (17) | in the sixth column, expiration of approval, of row 276, Chlormequat, the date is replaced by ‘28 February 2027’; |
| --- | --- |

(17)

in the sixth column, expiration of approval, of row 276, Chlormequat, the date is replaced by ‘28 February 2027’;

| (18) | in the sixth column, expiration of approval, of row 278, Propaquizafop, the date is replaced by ‘28 February 2027’; |
| --- | --- |

(18)

in the sixth column, expiration of approval, of row 278, Propaquizafop, the date is replaced by ‘28 February 2027’;

| (19) | in the sixth column, expiration of approval, of row 279, Quizalofop-P-ethyl and Quizalofop-P-tefuryl, the date is replaced by ‘28 February 2027’; |
| --- | --- |

(19)

in the sixth column, expiration of approval, of row 279, Quizalofop-P-ethyl and Quizalofop-P-tefuryl, the date is replaced by ‘28 February 2027’;

| (20) | in the sixth column, expiration of approval, of row 307, Sulfuryl fluoride, the date is replaced by ‘31 January 2027’. |
| --- | --- |

(20)

in the sixth column, expiration of approval, of row 307, Sulfuryl fluoride, the date is replaced by ‘31 January 2027’.

2.

| (1) | in the sixth column, expiration of approval, of row 45, Eugenol, the date is replaced by ‘30 April 2026’; |
| --- | --- |

(1)

in the sixth column, expiration of approval, of row 45, Eugenol, the date is replaced by ‘30 April 2026’;

| (2) | in the sixth column, expiration of approval, of row 46, Geraniol, the date is replaced by ‘30 April 2026’; |
| --- | --- |

(2)

in the sixth column, expiration of approval, of row 46, Geraniol, the date is replaced by ‘30 April 2026’;

| (3) | in the sixth column, expiration of approval, of row 47, Thymol, the date is replaced by ‘30 April 2026’; |
| --- | --- |

(3)

in the sixth column, expiration of approval, of row 47, Thymol, the date is replaced by ‘30 April 2026’;

3.

| | in the sixth column, expiration of approval, of row 1, Flumetralin, the date is replaced by ‘
  11 May 2026
  ’. |
| --- | --- |

in the sixth column, expiration of approval, of row 1, Flumetralin, the date is replaced by ‘
  11 May 2026
  ’.

---

| 12.9.2023 | EN | Official Journal of the European Union | L 224/34 |
| --- | --- | --- | --- |

12.9.2023

EN

Official Journal of the European Union

L 224/34

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1758

of 11 September 2023

granting a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with Regulation (EU) No 528/2012 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) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:

| (1) | On 26 April 2019, Salveco SAS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘SALVECO SALVESAFE PRODUCTS’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-HC051278-51 in the Register for Biocidal Products. |
| --- | --- |

(1)

On 26 April 2019, Salveco SAS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘SALVECO SALVESAFE PRODUCTS’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-HC051278-51 in the Register for Biocidal Products.

| (2) | ‘SALVECO SALVESAFE PRODUCTS’ contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2, 3 and 4. |
| --- | --- |

(2)

‘SALVECO SALVESAFE PRODUCTS’ contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2, 3 and 4.

| (3) | On 7 January 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. |
| --- | --- |

(3)

On 7 January 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

| (4) | On 5 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘SALVECO SALVESAFE PRODUCTS’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 5 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘SALVECO SALVESAFE PRODUCTS’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

| (5) | The opinion concludes that ‘SALVECO SALVESAFE PRODUCTS’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
| --- | --- |

(5)

The opinion concludes that ‘SALVECO SALVESAFE PRODUCTS’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

| (6) | On 20 July 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(6)

On 20 July 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’. |
| --- | --- |

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0028967-0000 is hereby granted to Salveco SAS for the making available on the market and use of the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 2 October 2023 to 30 September 2033.

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, 11 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  ECHA opinion of 15 June 2022 on the Union authorisation of ‘SALVECO SALVESAFE PRODUCTS’ (ECHA/BPC/346/2022), https://echa.europa.eu/opinions-on-union-authorisation.

2

---

ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

SALVECO SALVESAFE PRODUCTS

Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 3 - Veterinary hygiene (Disinfectants)

Product type 4 - Food and feed area (Disinfectants)

Authorisation number: EU-0028967-0000

R4BP asset number: EU-0028967-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | SALVECO SALVESAFE PRODUCTS |
| --- | --- |

Name

SALVECO SALVESAFE PRODUCTS

1.2.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT03 - Veterinary hygiene (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

PT04 - Food and feed area (Disinfectants)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | SALVECO S.A.S. |
| --- | --- | --- |
| Address | Avenue Pierre Mendès-France Z.A. Hellieule 4, F 88100 SAINT DIE DES VOSGES France |
| Authorisation number | EU-0028967-0000 |
| R4BP asset number | EU-0028967-0000 |
| Date of the authorisation | 2 October 2023 |
| Expiry date of the authorisation | 30 September 2033 |

Name and address of the authorisation holder

Name

SALVECO S.A.S.

Address

Avenue Pierre Mendès-France Z.A. Hellieule 4, F 88100 SAINT DIE DES VOSGES France

Authorisation number

EU-0028967-0000

R4BP asset number

EU-0028967-0000

Date of the authorisation

2 October 2023

Expiry date of the authorisation

30 September 2033

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | SALVECO S.A.S |
| --- | --- |
| Address of manufacturer | Avenue Pierre Mendès-France, F-88100 SAINT DIE DES VOSGES France |
| Location of manufacturing sites | Avenue Pierre Mendès-France, F-88100 SAINT DIE DES VOSGES France |

Name of manufacturer

SALVECO S.A.S

Address of manufacturer

Avenue Pierre Mendès-France, F-88100 SAINT DIE DES VOSGES France

Location of manufacturing sites

Avenue Pierre Mendès-France, F-88100 SAINT DIE DES VOSGES France

| Name of manufacturer | GESTRA S.A.S |
| --- | --- |
| Address of manufacturer | Allée Robert Schumann, F-88110 RAON-L’ETAPE France |
| Location of manufacturing sites | Allée Robert Schumann, F-88110 RAON-L’ETAPE France |

Name of manufacturer

GESTRA S.A.S

Address of manufacturer

Allée Robert Schumann, F-88110 RAON-L’ETAPE France

Location of manufacturing sites

Allée Robert Schumann, F-88110 RAON-L’ETAPE France

1.5.   Manufacturer(s) of the active substance(s)

| Active substance | L-(+)-lactic acid |
| --- | --- |
| Name of manufacturer | PURAC BIOCHEM BV |
| Address of manufacturer | Gran Vial 19-25, 08160 Montmelo Spain |
| Location of manufacturing sites | Gran Vial 19-25, 08160 Montmelo Spain |

Active substance

L-(+)-lactic acid

Name of manufacturer

PURAC BIOCHEM BV

Address of manufacturer

Gran Vial 19-25, 08160 Montmelo Spain

Location of manufacturing sites

Gran Vial 19-25, 08160 Montmelo Spain

| Active substance | L-(+)-lactic acid |
| --- | --- |
| Name of manufacturer | JUNGBUNGZLAUER S.A |
| Address of manufacturer | Z.I Portuaire BP 32, 67390 Marckolsheim France |
| Location of manufacturing sites | Z.I Portuaire BP 32, 67390 Marckolsheim France |

Active substance

L-(+)-lactic acid

Name of manufacturer

JUNGBUNGZLAUER S.A

Address of manufacturer

Z.I Portuaire BP 32, 67390 Marckolsheim France

Location of manufacturing sites

Z.I Portuaire BP 32, 67390 Marckolsheim France

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 0,0 | 28,8 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 0,0 | 8,23 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

0,627

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

0,0

28,8

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

0,0

8,23

2.2.   Type(s) of formulation

| Formulation(s) | SL – Soluble Concentrate
  AL – Any other liquids |
| --- | --- |

Formulation(s)

SL – Soluble Concentrate

AL – Any other liquids

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

| Identifier | meta-SPC1 |
| --- | --- |

Identifier

meta-SPC1

1.2.   Suffix to the authorisation number

| Number | 1-1 |
| --- | --- |

Number

1-1

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 | 8,23 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

15,66

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

13,5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

3,52

8,23

2.2.   Type(s) of formulation of the meta SPC 1

| Formulation(s) | SL – Soluble Concentrate |
| --- | --- |

Formulation(s)

SL – Soluble Concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | Causes skin irritation.
  Causes serious eye damage. |
| --- | --- |
| Precautionary statements | If medical advice is needed, have product container or label at hand.
  Keep out of reach of children.
  Read carefully and follow all instructions.
  Wash hands thoroughly after handling.
  Wear protective gloves, protective clothing and eye protection.
  IF ON SKIN:Wash with plenty of water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER or doctor.
  Specific treatment (see supplemental first aid instruction on this label).
  If skin irritation occurs:Get medical advice.
  Take off contaminated clothing.And wash it before reuse. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

Read carefully and follow all instructions.

Wash hands thoroughly after handling.

Wear protective gloves, protective clothing and eye protection.

IF ON SKIN:Wash with plenty of water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Specific treatment (see supplemental first aid instruction on this label).

If skin irritation occurs:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

4.   AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description

Table 1

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional, medical and industrial areas)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage:
  Scientific name: Viruses
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Outdoor
  In domestic, institutional, medical and industrial areas |
| Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
  Detailed description:






  — | without mechanical action |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Viruses

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Outdoor

In domestic, institutional, medical and industrial areas

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299% to 1,496%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C

Other target organisms:

| — | Enveloped viruses and yeasts: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Enveloped viruses and yeasts: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C

Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.

Category(ies) of users

Professional

General public (non-professional)

Pack sizes and packaging material

Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle

| | Refill caps: 20 - 100ml high density polyethylene (HDPE) |
| --- | --- |

Refill caps: 20 - 100ml high density polyethylene (HDPE)

| | Bottles: 0,5 - 5 liters HDPE or polyethylene terephtalate (PET) |
| --- | --- |

Bottles: 0,5 - 5 liters HDPE or polyethylene terephtalate (PET)

| | Jerry can: 1-80 liters HDPE (only for professional users) |
| --- | --- |

Jerry can: 1-80 liters HDPE (only for professional users)

| | Drum: 10-210 liters HDPE (only for professional users) |
| --- | --- |

Drum: 10-210 liters HDPE (only for professional users)

| | Intermediate bulk container (IBC): 1 000 liters HDPE (only for professional users) |
| --- | --- |

Intermediate bulk container (IBC): 1 000 liters HDPE (only for professional users)

4.1.1.   Use-specific instructions for use

See general instructions for use.

4.1.2.   Use-specific risk mitigation measures

See general instructions for use.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use.

4.2.   Use description

Table 2

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and food industry areas

| Product type | PT04 - Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | in domestic, institutional and food industry areas (general disinfection) |

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Outdoor

—

in domestic, institutional and food industry areas (general disinfection)

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299% to 1,496%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeast: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeast: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C

Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.

Category(ies) of users

Professional

General public (non-professional)

Pack sizes and packaging material

Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle

| | Refill caps: 20 - 100ml high density polyethylene (HDPE) |
| --- | --- |

Refill caps: 20 - 100ml high density polyethylene (HDPE)

| | Bottles: 0,5 - 5 liters HDPE or polyethylene terephtalate (PET) |
| --- | --- |

Bottles: 0,5 - 5 liters HDPE or polyethylene terephtalate (PET)

| | Jerry can: 1-80 liters HDPE (only for professional users) |
| --- | --- |

Jerry can: 1-80 liters HDPE (only for professional users)

| | Drum: 10-210 liters HDPE (only for professional users) |
| --- | --- |

Drum: 10-210 liters HDPE (only for professional users)

| | Intermediate bulk container (IBC): 1 000 liters HDPE (only for professional users) |
| --- | --- |

Intermediate bulk container (IBC): 1 000 liters HDPE (only for professional users)

4.2.1.   Use-specific instructions for use

See general instructions for use.

4.2.2.   Use-specific risk mitigation measures

See general instructions for use.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use.

5.   GENERAL DIRECTIONS FOR USE (1)
  OF THE META SPC 1

5.1.   Instructions for use

| — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected). |
| --- | --- |

—

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).

| — | Apply only on non-porous surfaces. |
| --- | --- |

—

Apply only on non-porous surfaces.

| — | Inform the authorisation holder if the treatment is ineffective. |
| --- | --- |

—

Inform the authorisation holder if the treatment is ineffective.

| — | Comply with the instructions for use. |
| --- | --- |

—

Comply with the instructions for use.

| — | Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 15,66% to 31,33%, it is not possible to indicate all product dilution here. |
| --- | --- |

—

Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 15,66% to 31,33%, it is not possible to indicate all product dilution here.

| Example for a product containing 15,66% L-(+)-lactic acid

  Bacterial and yeasticidal activity | Dilution of the product
  0,299% (20 ml product, add water up to 1 liter) | Contact time
  5 minutes |
| --- | --- | --- |

Example for a product containing 15,66% L-(+)-lactic acid

Bacterial and yeasticidal activity

Dilution of the product

0,299% (20 ml product, add water up to 1 liter)

Contact time

5 minutes

The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water for each specific product.

5.2.   Risk mitigation measures

| — | Wash hands after use of the concentrate product. |
| --- | --- |

—

Wash hands after use of the concentrate product.

| — | Avoid contact with eyes. |
| --- | --- |

—

Avoid contact with eyes.

| — | Avoid splashes and spills during mixing and loading (dilution). |
| --- | --- |

—

Avoid splashes and spills during mixing and loading (dilution).

| — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. |
| --- | --- |

—

For outdoor uses, do not apply the product in case rain is expected within 24 hours.

| — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). |
| --- | --- |

—

For outdoor uses by spray, avoid transfer to other areas by wind (drift).

For professional use only:

| — | Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full texts of the EN standards are available in Section 6. – Personal protective equipment (PPE) material to be specified by the authorisation holder within the product information. |
| --- | --- |

—

Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full texts of the EN standards are available in Section 6. – Personal protective equipment (PPE) material to be specified by the authorisation holder within the product information.

For non-professional use only:

| — | A child-proof closure is required. |
| --- | --- |

—

A child-proof closure is required.

| — | Keep out of reach of children and non-target animals or pets. |
| --- | --- |

—

Keep out of reach of children and non-target animals or pets.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

| — | If medical advice is needed, have product container or label at hand |
| --- | --- |

—

If medical advice is needed, have product container or label at hand

| — | IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

—

IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

| — | IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. |
| --- | --- |

—

IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 or an ambulance for medical assistance.

Information to healthcare personnel or a doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.

| — | IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance. |
| --- | --- |

—

IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

| — | IF INHALED: if symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.

5.4.   Instructions for safe disposal of the product and its packaging

| — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains. |
| --- | --- |

—

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

| — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. |
| --- | --- |

—

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

| — | Keep out of reach of children and non-target animals or pets. |
| --- | --- |

—

Keep out of reach of children and non-target animals or pets.

| — | Shelf-life: 2 years. |
| --- | --- |

—

Shelf-life: 2 years.

| — | Protect from frost. |
| --- | --- |

—

Protect from frost.

6.   OTHER INFORMATION

| — | P280 (Wear protective gloves/protective clothing/eye protection/face protection) is not applicable for the non-professional user. |
| --- | --- |

—

P280 (Wear protective gloves/protective clothing/eye protection/face protection) is not applicable for the non-professional user.

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

| | EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
| --- | --- |

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

| | EN 16321 - Eye and face protection for occupational use |
| --- | --- |

EN 16321 - Eye and face protection for occupational use

| | EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) |
| --- | --- |

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_1 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 8,23 |

Trade name(s)

SALVE FAM1_1

Market area: EU

Authorisation number

EU-0028967-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

8,23

7.2.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_5 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0002 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 20,89 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 18,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,49 |

Trade name(s)

SALVE FAM1_5

Market area: EU

Authorisation number

EU-0028967-0002 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

20,89

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

18,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

5,49

7.3.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_9 | Market area: EU |
| --- | --- | --- |
| | OSANIS – Nettoyant désinfectant concentré | Market area: EU |
| Authorisation number | EU-0028967-0003 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 |

Trade name(s)

SALVE FAM1_9

Market area: EU

OSANIS – Nettoyant désinfectant concentré

Market area: EU

Authorisation number

EU-0028967-0003 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

15,66

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

13,5

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

4,11

7.4.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_13 | Market area: EU |
| --- | --- | --- |
| | MILTON - Dégraissant désinfectant | Market area: EU |
| Authorisation number | EU-0028967-0004 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 |

Trade name(s)

SALVE FAM1_13

Market area: EU

MILTON - Dégraissant désinfectant

Market area: EU

Authorisation number

EU-0028967-0004 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

3,52

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | meta-SPC2 |
| --- | --- |

Identifier

meta-SPC2

1.2.   Suffix to the authorisation number

| Number | 1-2 |
| --- | --- |

Number

1-2

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 | 8,23 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

15,66

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

13,5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

3,52

8,23

2.2.   Type(s) of formulation of the meta SPC 2

| Formulation(s) | SL – Soluble Concentrate |
| --- | --- |

Formulation(s)

SL – Soluble Concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | Causes skin irritation.
  Causes serious eye damage.
  Contains Eucalyptol, Carvone and Limonene. May produce an allergic reaction.
  Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction.
  Contains Eucalyptol (Ecalyptus leaves fragrance). May produce an allergic reaction. |
| --- | --- |
| Precautionary statements | If medical advice is needed, have product container or label at hand.
  Keep out of reach of children.
  Read carefully and follow all instructions.
  Wash hands thoroughly after handling.
  Wear protective gloves, protective clothing and eye protection.
  IF ON SKIN:Wash with plenty of water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER or doctor.
  Specific treatment (see supplemental first aid instruction on this label).
  If skin irritation occurs:Get medical advice.
  Take off contaminated clothing.And wash it before reuse. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Contains Eucalyptol, Carvone and Limonene. May produce an allergic reaction.

Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction.

Contains Eucalyptol (Ecalyptus leaves fragrance). May produce an allergic reaction.

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

Read carefully and follow all instructions.

Wash hands thoroughly after handling.

Wear protective gloves, protective clothing and eye protection.

IF ON SKIN:Wash with plenty of water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Specific treatment (see supplemental first aid instruction on this label).

If skin irritation occurs:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description

Table 3

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional, medical and industrial areas)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage:
  Scientific name: Viruses
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Outdoor
  in domestic, institutional, medical and industrial area. |
| Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
  Detailed description:






  — | without mechanical action. |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Viruses

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Outdoor

in domestic, institutional, medical and industrial area.

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

—

without mechanical action.

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299% to 1,496%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C

Other target organisms:

| — | Enveloped viruses and yeasts: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Enveloped viruses and yeasts: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C

Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.

Category(ies) of users

Professional

General public (non-professional)

Pack sizes and packaging material

Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle

Refill caps: 20 - 100 ml HDPE

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE (only for professional users)

Drum: 10-210 liters HDPE (only for professional users)

IBC: 1 000 liters HDPE (only for professional users)

4.1.1.   Use-specific instructions for use

See general instructions for use

4.1.2.   Use-specific risk mitigation measures

See general instructions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

4.2.   Use description

Table 4

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and food industry areas)

| Product type | PT04 - Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | in domestic, institutional and food industry areas (general disinfection) |

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Outdoor

—

in domestic, institutional and food industry areas (general disinfection)

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299% to 1,496%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeast: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeast: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C

Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.

Category(ies) of users

Professional

General public (non-professional)

Pack sizes and packaging material

Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle

Refill caps: 20 - 100ml HDPE

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE (only for professional users)

Drum: 10-210 liters HDPE (only for professional users)

IBC: 1 000 liters HDPE (only for professional users)

4.2.1.   Use-specific instructions for use

See general instructions for use

4.2.2.   Use-specific risk mitigation measures

See general instructions for use

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

5.   GENERAL DIRECTIONS FOR USE (2)
  OF THE META SPC 2

5.1.   Instructions for use

| — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected). |
| --- | --- |

—

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).

| — | Apply only on non porous surfaces. |
| --- | --- |

—

Apply only on non porous surfaces.

| — | Inform the authorisation holder if the treatment is ineffective. |
| --- | --- |

—

Inform the authorisation holder if the treatment is ineffective.

| — | Comply with the instructions for use. |
| --- | --- |

—

Comply with the instructions for use.

| — | Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 15,66% to 31,33%, it is not possible to indicate all product dilution here. |
| --- | --- |

—

Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 15,66% to 31,33%, it is not possible to indicate all product dilution here.

| Example for a product containing 15,66% L-(+)-lactic acid

  Bacterial and yeasticidal activity | Dilution of the product
  0,299% (20 ml product, add water up to 1 liter) | Contact time
  5 minutes |
| --- | --- | --- |

Example for a product containing 15,66% L-(+)-lactic acid

Bacterial and yeasticidal activity

Dilution of the product

0,299% (20 ml product, add water up to 1 liter)

Contact time

5 minutes

The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product.

5.2.   Risk mitigation measures

| — | Wash hands after use of the concentrate product. |
| --- | --- |

—

Wash hands after use of the concentrate product.

| — | Avoid contact with eyes |
| --- | --- |

—

Avoid contact with eyes

| — | Avoid splashes and spills during mixing and load ing (dilution). |
| --- | --- |

—

Avoid splashes and spills during mixing and load ing (dilution).

| — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. |
| --- | --- |

—

For outdoor uses, do not apply the product in case rain is expected within 24 hours.

| — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). |
| --- | --- |

—

For outdoor uses by spray, avoid transfer to other areas by wind (drift).

For professional use only:

| — | Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titles of the EN standards are available in Section 6. – PPE material to be specified by the authorisation holder within the product information. |
| --- | --- |

—

Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titles of the EN standards are available in Section 6. – PPE material to be specified by the authorisation holder within the product information.

For non-professional use only:

| — | A child-proof closure is required. |
| --- | --- |

—

A child-proof closure is required.

| — | Keep out of reach of children and non-target animals or pets. |
| --- | --- |

—

Keep out of reach of children and non-target animals or pets.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

| — | If medical advice is needed, have product container or label at hand |
| --- | --- |

—

If medical advice is needed, have product container or label at hand

| — | IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: Get medical advice. |
| --- | --- |

—

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: Get medical advice.

| — | IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. |
| --- | --- |

—

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 or an ambulance for medical assistance.

Information to healthcare personnel or doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

| — | IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance. |
| --- | --- |

—

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

| — | IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

5.4.   Instructions for safe disposal of the product and its packaging

| — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains. |
| --- | --- |

—

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

| — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. |
| --- | --- |

—

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

| — | Keep out of reach of children and non-target animals or pets. |
| --- | --- |

—

Keep out of reach of children and non-target animals or pets.

| — | Shelf-life: 2 years. |
| --- | --- |

—

Shelf-life: 2 years.

| — | Protect from frost. |
| --- | --- |

—

Protect from frost.

6.   OTHER INFORMATION

| — | P280 is not applicable for the non-professional user. |
| --- | --- |

—

P280 is not applicable for the non-professional user.

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

| | EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
| --- | --- |

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

| | EN 16321 - Eye and face protection for occupational use |
| --- | --- |

EN 16321 - Eye and face protection for occupational use

| | EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) |
| --- | --- |

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_2 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0005 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 8,23 |

Trade name(s)

SALVE FAM1_2

Market area: EU

Authorisation number

EU-0028967-0005 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

8,23

7.2.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_3 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0006 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 8,23 |

Trade name(s)

SALVE FAM1_3

Market area: EU

Authorisation number

EU-0028967-0006 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

8,23

7.3.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_4 | Market area: EU |
| --- | --- | --- |
| | MAISON VERTE - Recharge pour spray désinfectant multi-usages | Market area: EU |
| MAISON VERTE PRO - Recharge pour spray désinfectant multi-usages | Market area: EU |
| MAISON VERTE PRO - Recharge pour spray désinfectant salle de bain | Market area: EU |
| SANIVERT - Recharge pour spray désinfectant multi-usages | Market area: EU |
| YOU - Recharge désinfectant toutes surfaces | Market area: EU |
| YOU - Recharge désinfectant WC | Market area: EU |
| SANILAK - Recharge Nettoyant désinfectant multi-usages Eucalyptus | Market area: EU |
| SANILAK - Recharge Nettoyant désinfectant sanitaires Eucalyptus | Market area: EU |
| SANILAK - Recharge Nettoyant désinfectant cuisine Eucalyptus | Market area: EU |
| YOU - Refill All purpose disinfecting cleaner | Market area: EU |
| Authorisation number | EU-0028967-0007 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 8,23 |

Trade name(s)

SALVE FAM1_4

Market area: EU

MAISON VERTE - Recharge pour spray désinfectant multi-usages

Market area: EU

MAISON VERTE PRO - Recharge pour spray désinfectant multi-usages

Market area: EU

MAISON VERTE PRO - Recharge pour spray désinfectant salle de bain

Market area: EU

SANIVERT - Recharge pour spray désinfectant multi-usages

Market area: EU

YOU - Recharge désinfectant toutes surfaces

Market area: EU

YOU - Recharge désinfectant WC

Market area: EU

SANILAK - Recharge Nettoyant désinfectant multi-usages Eucalyptus

Market area: EU

SANILAK - Recharge Nettoyant désinfectant sanitaires Eucalyptus

Market area: EU

SANILAK - Recharge Nettoyant désinfectant cuisine Eucalyptus

Market area: EU

YOU - Refill All purpose disinfecting cleaner

Market area: EU

Authorisation number

EU-0028967-0007 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

8,23

7.4.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_6 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0008 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 20,89 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 18,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,49 |

Trade name(s)

SALVE FAM1_6

Market area: EU

Authorisation number

EU-0028967-0008 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

20,89

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

18,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

5,49

7.5.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_7 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0009 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 20,89 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 18,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,49 |

Trade name(s)

SALVE FAM1_7

Market area: EU

Authorisation number

EU-0028967-0009 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

20,89

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

18,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

5,49

7.6.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_8 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0010 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 20,89 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 18,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,49 |

Trade name(s)

SALVE FAM1_8

Market area: EU

Authorisation number

EU-0028967-0010 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

20,89

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

18,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

5,49

7.7.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_10 | Market area: EU |
| --- | --- | --- |
| | SANILAK - Nettoyant désinfectant concentré Menthe | Market area: EU |
| SANILAK - Recharge Nettoyant désinfectant sols et surfaces Menthe | Market area: EU |
| Authorisation number | EU-0028967-0011 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 |

Trade name(s)

SALVE FAM1_10

Market area: EU

SANILAK - Nettoyant désinfectant concentré Menthe

Market area: EU

SANILAK - Recharge Nettoyant désinfectant sols et surfaces Menthe

Market area: EU

Authorisation number

EU-0028967-0011 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

15,66

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

13,5

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

4,11

7.8.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_11 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0012 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 |

Trade name(s)

SALVE FAM1_11

Market area: EU

Authorisation number

EU-0028967-0012 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

15,66

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

13,5

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

4,11

7.9.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_12 | Market area: EU |
| --- | --- | --- |
| | MAISON VERTE - Recharge pour sol désinfectant multi-surfaces | Market area: EU |
| MAISON VERTE PRO - Recharge pour désinfectant sol | Market area: EU |
| MAISON VERTE PRO - Recharge pour désinfectant Multi-surfaces | Market area: EU |
| SANIVERT - Recharge désinfectant multi-surfaces | Market area: EU |
| YOU - Recharge désinfectant sols & surfaces | Market area: EU |
| SANILAK - Nettoyant désinfectant concentré Eucalyptus | Market area: EU |
| SANILAK - Recharge Nettoyant désinfectant sols et surfaces Eucalyptus | Market area: EU |
| Authorisation number | EU-0028967-0013 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 |

Trade name(s)

SALVE FAM1_12

Market area: EU

MAISON VERTE - Recharge pour sol désinfectant multi-surfaces

Market area: EU

MAISON VERTE PRO - Recharge pour désinfectant sol

Market area: EU

MAISON VERTE PRO - Recharge pour désinfectant Multi-surfaces

Market area: EU

SANIVERT - Recharge désinfectant multi-surfaces

Market area: EU

YOU - Recharge désinfectant sols & surfaces

Market area: EU

SANILAK - Nettoyant désinfectant concentré Eucalyptus

Market area: EU

SANILAK - Recharge Nettoyant désinfectant sols et surfaces Eucalyptus

Market area: EU

Authorisation number

EU-0028967-0013 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

15,66

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

13,5

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

4,11

7.10.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_14 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0014 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 8,23 |

Trade name(s)

SALVE FAM1_14

Market area: EU

Authorisation number

EU-0028967-0014 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

8,23

7.11.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_15 | Market area: EU |
| --- | --- | --- |
| | TECH'LAB - Concentré détergent désinfectant sols & surfaces | Market area: EU |
| Authorisation number | EU-0028967-0015 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 |

Trade name(s)

SALVE FAM1_15

Market area: EU

TECH'LAB - Concentré détergent désinfectant sols & surfaces

Market area: EU

Authorisation number

EU-0028967-0015 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

15,66

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

13,5

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

4,11

7.12.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM1_16 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0016 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 |

Trade name(s)

SALVE FAM1_16

Market area: EU

Authorisation number

EU-0028967-0016 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

15,66

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

13,5

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

4,11

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

| Identifier | meta-SPC3 |
| --- | --- |

Identifier

meta-SPC3

1.2.   Suffix to the authorisation number

| Number | 1-3 |
| --- | --- |

Number

1-3

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 7,83 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 6,75 | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 1,32 | 3,52 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

7,83

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

6,75

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

1,32

3,52

2.2.   Type(s) of formulation of the meta SPC 3

| Formulation(s) | SL – Soluble Concentrate |
| --- | --- |

Formulation(s)

SL – Soluble Concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

| Hazard statements | Causes skin irritation.
  Causes serious eye damage. |
| --- | --- |
| Precautionary statements | Wash hands thoroughly after handling.
  Wear protective gloves, protective clothing and eye protection.
  IF ON SKIN:Wash with plenty of water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER or doctor.
  Specific treatment (see supplemental first aid instruction on this label).
  If skin irritation occurs:Get medical advice.
  Take off contaminated clothing.And wash it before reuse. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Precautionary statements

Wash hands thoroughly after handling.

Wear protective gloves, protective clothing and eye protection.

IF ON SKIN:Wash with plenty of water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Specific treatment (see supplemental first aid instruction on this label).

If skin irritation occurs:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description

Table 5

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional, and industrial areas)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage:
  Scientific name: Viruses
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | in institutional and industrial area |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Viruses

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Outdoor

—

in institutional and industrial area

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeasts: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeasts: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C

Other target organisms:

| — | Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C

Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.

Category(ies) of users

Professional

Pack sizes and packaging material

Refill caps: 20 – 100ml HDPE

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

4.1.1.   Use-specific instructions for use

See general instructions for use

4.1.2.   Use-specific risk mitigation measures

See general instructions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

4.2.   Use description

Table 6

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas)

| Product type | PT04 - Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | in institutional and industrial area (general) |

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Outdoor

—

in institutional and industrial area (general)

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeast: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeast: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C

Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.

Category(ies) of users

Professional

Pack sizes and packaging material

Refill caps: 20 – 100ml HDPE

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

4.2.1.   Use-specific instructions for use

See general instructions for use

4.2.2.   Use-specific risk mitigation measures

See general instructions for use

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

5.   GENERAL DIRECTIONS FOR USE (3)
  OF THE META SPC 3

5.1.   Instructions for use

| — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected). |
| --- | --- |

—

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).

| — | Apply only on non-porous surfaces. |
| --- | --- |

—

Apply only on non-porous surfaces.

| — | Inform the auhtorisation holder if the treatment is ineffective. |
| --- | --- |

—

Inform the auhtorisation holder if the treatment is ineffective.

| — | Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 7,83% to 31,33%, it is not possible to indicate all product dilution here.








  Example for a product containing 7,83% L-(+)-lactic acid

  Bacterial and yeasticidal activity | Dilution of the product
  0,299% (40 ml product, add water up to 1 liter) | Contact time
  5 minutes |
| --- | --- | --- | --- |

—

Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 7,83% to 31,33%, it is not possible to indicate all product dilution here.

Example for a product containing 7,83% L-(+)-lactic acid

Bacterial and yeasticidal activity

Dilution of the product

0,299% (40 ml product, add water up to 1 liter)

Contact time

5 minutes

The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product.

5.2.   Risk mitigation measures

| — | Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6. |
| --- | --- |

—

Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.

| — | PPE material to be specified by the authorisation holder within the product information. |
| --- | --- |

—

PPE material to be specified by the authorisation holder within the product information.

| — | Wash hands after use of the concentrate product. |
| --- | --- |

—

Wash hands after use of the concentrate product.

| — | Avoid contact with eyes. |
| --- | --- |

—

Avoid contact with eyes.

| — | Avoid splashes and spills during mixing and loading (dilution). |
| --- | --- |

—

Avoid splashes and spills during mixing and loading (dilution).

| — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. |
| --- | --- |

—

For outdoor uses, do not apply the product in case rain is expected within 24 hours.

| — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). |
| --- | --- |

—

For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

| — | IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

—

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

| — | IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. |
| --- | --- |

—

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 or an ambulance for medical assistance.

Information to healthcare personnel or a doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

| — | IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance. |
| --- | --- |

—

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

| — | IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

5.4.   Instructions for safe disposal of the product and its packaging

| — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains. |
| --- | --- |

—

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

| — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. |
| --- | --- |

—

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

| — | Shelf-life: 2 years. |
| --- | --- |

—

Shelf-life: 2 years.

| — | Protect from frost. |
| --- | --- |

—

Protect from frost.

6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

| | EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
| --- | --- |

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

| | EN 16321 - Eye and face protection for occupational use |
| --- | --- |

EN 16321 - Eye and face protection for occupational use

| | EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) |
| --- | --- |

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM2_1 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0017 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 1,76 |

Trade name(s)

SALVE FAM2_1

Market area: EU

Authorisation number

EU-0028967-0017 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

15,66

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

13,5

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

1,76

7.2.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM2_2 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0018 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 |

Trade name(s)

SALVE FAM2_2

Market area: EU

Authorisation number

EU-0028967-0018 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

3,52

7.3.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM2_6 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0019 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 7,83 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 6,75 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 1,32 |

Trade name(s)

SALVE FAM2_6

Market area: EU

Authorisation number

EU-0028967-0019 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

7,83

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

6,75

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

1,32

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

| Identifier | meta-SPC4 |
| --- | --- |

Identifier

meta-SPC4

1.2.   Suffix to the authorisation number

| Number | 1-4 |
| --- | --- |

Number

1-4

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 7,83 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 6,75 | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 1,32 | 5,28 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

7,83

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

6,75

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

1,32

5,28

2.2.   Type(s) of formulation of the meta SPC 4

| Formulation(s) | SL – Soluble Concentrate |
| --- | --- |

Formulation(s)

SL – Soluble Concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

| Hazard statements | Causes skin irritation.
  Causes serious eye damage.
  Contains Eucalyptol, Carvone and Limonene (Cool Mint fragrance). May produce an allergic reaction.
  Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction. |
| --- | --- |
| Precautionary statements | Wash hands thoroughly after handling.
  Wear protective gloves, protective clothing and eye protection.
  IF ON SKIN:Wash with plenty of water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER or doctor.
  Specific treatment (see supplemental first aid instruction on this label).
  If skin irritation occurs:Get medical advice.
  Take off contaminated clothing.And wash it before reuse. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Contains Eucalyptol, Carvone and Limonene (Cool Mint fragrance). May produce an allergic reaction.

Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction.

Precautionary statements

Wash hands thoroughly after handling.

Wear protective gloves, protective clothing and eye protection.

IF ON SKIN:Wash with plenty of water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Specific treatment (see supplemental first aid instruction on this label).

If skin irritation occurs:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

4.   AUTHORISED USE(S) OF THE META SPC 4

4.1.   Use description

Table 7

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional and industrial areas)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage:
  Scientific name: Viruses
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | In institutional and industrial area |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Viruses

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Outdoor

—

In institutional and industrial area

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeasts: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeasts: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C

Other target organisms:

| — | Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C

Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.

Category(ies) of users

Professional

Pack sizes and packaging material

Refill caps: 20 – 100ml HDPE

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

4.1.1.   Use-specific instructions for use

See general instructions for use

4.1.2.   Use-specific risk mitigation measures

See general instructions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

4.2.   Use description

Table 8

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas)

| Product type | PT04 - Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | In institutional and industrial area |

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Outdoor

—

In institutional and industrial area

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeast: 0,299% w/w L-(+)-lactic cid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeast: 0,299% w/w L-(+)-lactic cid, 5 minutes, 20°C

Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.

Category(ies) of users

Professional

Pack sizes and packaging material

Refill caps: 20 – 100ml HDPE

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

4.2.1.   Use-specific instructions for use

See general instructions for use

4.2.2.   Use-specific risk mitigation measures

See general instructions for use

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

5.   GENERAL DIRECTIONS FOR USE (4)
  OF THE META SPC 4

5.1.   Instructions for use

| — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected). |
| --- | --- |

—

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).

| — | Apply only on non porous surfaces. |
| --- | --- |

—

Apply only on non porous surfaces.

| — | Inform the authorisation holder if the treatment is ineffective. |
| --- | --- |

—

Inform the authorisation holder if the treatment is ineffective.

| — | Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 7,83% to 31,33%, it is not possible to indicate all product dilution here.








  Example for a product containing 7,83% L-(+)-lactic acid

  Bacterial and yeasticidal activity | Dilution of the product
  0,299% (40 ml product, add water up to 1 liter) | Contact time
  5 minutes |
| --- | --- | --- | --- |

—

Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 7,83% to 31,33%, it is not possible to indicate all product dilution here.

Example for a product containing 7,83% L-(+)-lactic acid

Bacterial and yeasticidal activity

Dilution of the product

0,299% (40 ml product, add water up to 1 liter)

Contact time

5 minutes

The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product.

5.2.   Risk mitigation measures

| — | Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6. |
| --- | --- |

—

Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.

| — | PPE material to be specified by the authorisation holder within the product information. |
| --- | --- |

—

PPE material to be specified by the authorisation holder within the product information.

| — | Wash hands after use of the concentrate product. |
| --- | --- |

—

Wash hands after use of the concentrate product.

| — | Avoid contact with eyes. |
| --- | --- |

—

Avoid contact with eyes.

| — | Avoid splashes and spills during mixing and loading (dilution). |
| --- | --- |

—

Avoid splashes and spills during mixing and loading (dilution).

| — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. |
| --- | --- |

—

For outdoor uses, do not apply the product in case rain is expected within 24 hours.

| — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). |
| --- | --- |

—

For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

| — | IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: Get medical advice. |
| --- | --- |

—

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: Get medical advice.

| — | IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. |
| --- | --- |

—

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 or an ambulance for medical assistance.

Information to healthcare personnel or a doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

| — | IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance. |
| --- | --- |

—

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

| — | IF INHALED: If symptoms occur call a POISON CENTER or a doctor. |
| --- | --- |

—

IF INHALED: If symptoms occur call a POISON CENTER or a doctor.

5.4.   Instructions for safe disposal of the product and its packaging

| — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains. |
| --- | --- |

—

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

| — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. |
| --- | --- |

—

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

| — | Shelf-life: 2 years. |
| --- | --- |

—

Shelf-life: 2 years.

| — | Protect from frost. |
| --- | --- |

—

Protect from frost.

6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

| | EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
| --- | --- |

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

| | EN 16321 - Eye and face protection for occupational use |
| --- | --- |

EN 16321 - Eye and face protection for occupational use

| | EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) |
| --- | --- |

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM2_3 | Market area: EU |
| --- | --- | --- |
| | ATOUT-VERT - DD303 | Market area: EU |
| SANILAK - Recharge Nettoyant Désinfectant Multi-usages Menthe | Market area: EU |
| SANILAK - Recharge Nettoyant Désinfectant Sanitaires Menthe | Market area: EU |
| SANILAK - Recharge Nettoyant Désinfectant Cuisine Menthe | Market area: EU |
| Authorisation number | EU-0028967-0020 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,28 |

Trade name(s)

SALVE FAM2_3

Market area: EU

ATOUT-VERT - DD303

Market area: EU

SANILAK - Recharge Nettoyant Désinfectant Multi-usages Menthe

Market area: EU

SANILAK - Recharge Nettoyant Désinfectant Sanitaires Menthe

Market area: EU

SANILAK - Recharge Nettoyant Désinfectant Cuisine Menthe

Market area: EU

Authorisation number

EU-0028967-0020 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

5,28

7.2.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM2_4 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0021 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,28 |

Trade name(s)

SALVE FAM2_4

Market area: EU

Authorisation number

EU-0028967-0021 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

27,0

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

5,28

7.3.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM2_5 | Market area: EU |
| --- | --- | --- |
| | ATOUT-VERT - DDP38 | Market area: EU |
| Authorisation number | EU-0028967-0022 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 7,83 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 6,75 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 1,32 |

Trade name(s)

SALVE FAM2_5

Market area: EU

ATOUT-VERT - DDP38

Market area: EU

Authorisation number

EU-0028967-0022 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

7,83

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

6,75

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

1,32

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

| Identifier | meta-SPC5 |
| --- | --- |

Identifier

meta-SPC5

1.2.   Suffix to the authorisation number

| Number | 1-5 |
| --- | --- |

Number

1-5

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT03 - Veterinary hygiene (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 28,8 | 28,8 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 | 3,52 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

28,8

28,8

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

3,52

3,52

2.2.   Type(s) of formulation of the meta SPC 5

| Formulation(s) | SL – Soluble Concentrate |
| --- | --- |

Formulation(s)

SL – Soluble Concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

| Hazard statements | Causes skin irritation.
  Causes serious eye damage. |
| --- | --- |
| Precautionary statements | Wash hands thoroughly after handling.
  Wear protective gloves, protective clothing and eye protection.
  IF ON SKIN:Wash with plenty of water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER or doctor.
  Specific treatment (see supplemental first aid instruction on this label).
  If skin irritation occurs:Get medical advice.
  Take off contaminated clothing.And wash it before reuse. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Precautionary statements

Wash hands thoroughly after handling.

Wear protective gloves, protective clothing and eye protection.

IF ON SKIN:Wash with plenty of water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Specific treatment (see supplemental first aid instruction on this label).

If skin irritation occurs:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

4.   AUTHORISED USE(S) OF THE META SPC 5

4.1.   Use description

Table 9

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional, medical, and industrial areas)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage:
  Scientific name: Viruses
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | In institutional, medical and industrial area |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Viruses

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Outdoor

—

In institutional, medical and industrial area

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion except in medical areas, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,4485%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeasts: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeasts: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C

Other target organisms:

| — | Enveloped viruses: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Enveloped viruses: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C

The concentrated product is to be diluted at 1,5% v/v before use.

Category(ies) of users

Professional

Pack sizes and packaging material

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

4.1.1.   Use-specific instructions for use

See general instructions for use

4.1.2.   Use-specific risk mitigation measures

See general instructions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

4.2.   Use description

Table 10

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial (food industry) areas)

| Product type | PT04 - Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | In institutional and industrial (food industry (general, meat (except slaughterhouses) and milk industries)) area |

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Outdoor

—

In institutional and industrial (food industry (general, meat (except slaughterhouses) and milk industries)) area

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,4485% to 0,598%

Number and timing of application:

General disinfection and meat industries

Mandatory target organisms:

| — | Bacteria and yeast: 0,4485% to 0,598% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeast: 0,4485% to 0,598% w/w L-(+)-lactic acid, 5 minutes, 20°C

The concentrated product is to be diluted between 1,5% and 2% v/v before use.

Milk industries

Mandatory target organisms:

| — | Bacteria and yeast: 0,598% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeast: 0,598% w/w L-(+)-lactic acid, 5 minutes, 20°C

The concentrated product is to be diluted at 2% v/v before use.

Category(ies) of users

Professional

Pack sizes and packaging material

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

4.2.1.   Use-specific instructions for use

See general instructions for use

4.2.2.   Use-specific risk mitigation measures

See general instructions for use

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

4.3.   Use description

Table 11

Use # 3 – Disinfectants used to disinfect the materials and surfaces associated with the housing of animals (disinfectants for all washable hard surfaces in veterinary area)

| Product type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: other: bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: other: yeast
  Common name: Yeast
  Development stage: |
| Field(s) of use | Indoor
  Outdoor |
| Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
  Detailed description:






  — | without mechanical action |

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeast

Development stage:

Field(s) of use

Indoor

Outdoor

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeast: 0,299% w/w L-(+)-lactic acid 30 minutes, 10°C |
| --- | --- |

—

Bacteria and yeast: 0,299% w/w L-(+)-lactic acid 30 minutes, 10°C

The concentrated product is to be diluted at 1% v/v before use.

Category(ies) of users

Professional

Pack sizes and packaging material

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

4.3.1.   Use-specific instructions for use

| — | Clean carefully the surfaces before application of the product. |
| --- | --- |

—

Clean carefully the surfaces before application of the product.

4.3.2.   Use-specific risk mitigation measures

See general instructions for use

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

5.   GENERAL DIRECTIONS FOR USE (5)
  OF THE META SPC 5

5.1.   Instructions for use

| — | Apply the product by fully wetting all surface for 5 to 30 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected). |
| --- | --- |

—

Apply the product by fully wetting all surface for 5 to 30 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).

| — | Apply only on non-porous surfaces. |
| --- | --- |

—

Apply only on non-porous surfaces.

| — | Inform the auhtorisation holder if the treatment is ineffective. |
| --- | --- |

—

Inform the auhtorisation holder if the treatment is ineffective.

5.2.   Risk mitigation measures

| — | Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6. |
| --- | --- |

—

Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.

| — | PPE material to be specified by the authorisation holder within the product information. |
| --- | --- |

—

PPE material to be specified by the authorisation holder within the product information.

| — | Wash hands after use of the concentrate product. |
| --- | --- |

—

Wash hands after use of the concentrate product.

| — | Avoid contact with eyes. |
| --- | --- |

—

Avoid contact with eyes.

| — | Avoid splashes and spills during mixing and loading (dilution). |
| --- | --- |

—

Avoid splashes and spills during mixing and loading (dilution).

| — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. |
| --- | --- |

—

For outdoor uses, do not apply the product in case rain is expected within 24 hours.

| — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). |
| --- | --- |

—

For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

| — | IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

—

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

| — | IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. |
| --- | --- |

—

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 or an ambulance for medical assistance.

Information to healthcare personnel or a doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

| — | IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance. |
| --- | --- |

—

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

| — | IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

5.4.   Instructions for safe disposal of the product and its packaging

| — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains. |
| --- | --- |

—

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

| — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. |
| --- | --- |

—

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

| — | Shelf-life: 2 years. |
| --- | --- |

—

Shelf-life: 2 years.

| — | Protect from frost. |
| --- | --- |

—

Protect from frost.

6.   OTHER INFORMATION

| — | The product is a foaming formulation. |
| --- | --- |

—

The product is a foaming formulation.

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

| | EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
| --- | --- |

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

| | EN 16321 - Eye and face protection for occupational use |
| --- | --- |

EN 16321 - Eye and face protection for occupational use

| | EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) |
| --- | --- |

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM3_1 | Market area: EU |
| --- | --- | --- |
| | CLEAN DESINFECTANT | Market area: EU |
| GERM D | Market area: EU |
| Authorisation number | EU-0028967-0023 1-5 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 28,8 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 |

Trade name(s)

SALVE FAM3_1

Market area: EU

CLEAN DESINFECTANT

Market area: EU

GERM D

Market area: EU

Authorisation number

EU-0028967-0023 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

28,8

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

3,52

META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

| Identifier | meta-SPC6 |
| --- | --- |

Identifier

meta-SPC6

1.2.   Suffix to the authorisation number

| Number | 1-6 |
| --- | --- |

Number

1-6

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.   META SPC 6 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 6

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 28,8 | 28,8 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,28 | 5,28 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

28,8

28,8

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

5,28

5,28

2.2.   Type(s) of formulation of the meta SPC 6

| Formulation(s) | SL – Soluble Concentrate |
| --- | --- |

Formulation(s)

SL – Soluble Concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

| Hazard statements | Causes skin irritation.
  Causes serious eye damage.
  Contains Eucalyptol and Carvone. May produce an allergic reaction. |
| --- | --- |
| Precautionary statements | Wash hands thoroughly after handling.
  Wear protective gloves, protective clothing and eye protection.
  IF ON SKIN:Wash with plenty of water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER or doctor.
  Specific treatment (see supplemental first aid instruction on this label).
  If skin irritation occurs:Get medical advice.
  Take off contaminated clothing.And wash it before reuse. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Contains Eucalyptol and Carvone. May produce an allergic reaction.

Precautionary statements

Wash hands thoroughly after handling.

Wear protective gloves, protective clothing and eye protection.

IF ON SKIN:Wash with plenty of water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Specific treatment (see supplemental first aid instruction on this label).

If skin irritation occurs:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

4.   AUTHORISED USE(S) OF THE META SPC 6

4.1.   Use description

Table 12

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in medical area)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage:
  Scientific name: Viruses
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | in medical area |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Viruses

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Outdoor

—

in medical area

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,4485%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeast: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeast: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C

Other target organisms:

| — | Enveloped viruses: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Enveloped viruses: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C

The concentrated product is to be diluted at 1,5 % before use.

Category(ies) of users

Professional

Pack sizes and packaging material

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

4.1.1.   Use-specific instructions for use

See general instructions for use

4.1.2.   Use-specific risk mitigation measures

See general instructions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

5.   GENERAL DIRECTIONS FOR USE (6)
  OF THE META SPC 6

5.1.   Instructions for use

| — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected). |
| --- | --- |

—

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).

| — | Apply only on non porous surfaces. |
| --- | --- |

—

Apply only on non porous surfaces.

| — | Inform the authorisation holder if the treatment is ineffective. |
| --- | --- |

—

Inform the authorisation holder if the treatment is ineffective.

5.2.   Risk mitigation measures

| — | Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6. |
| --- | --- |

—

Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.

| — | PPE material to be specified by the authorisation holder within the product information. |
| --- | --- |

—

PPE material to be specified by the authorisation holder within the product information.

| — | Wash hands after use of the concentrate product. |
| --- | --- |

—

Wash hands after use of the concentrate product.

| — | Avoid contact with eyes. |
| --- | --- |

—

Avoid contact with eyes.

| — | Avoid splashes and spills during mixing and loading (dilution). |
| --- | --- |

—

Avoid splashes and spills during mixing and loading (dilution).

| — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. |
| --- | --- |

—

For outdoor uses, do not apply the product in case rain is expected within 24 hours.

| — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). |
| --- | --- |

—

For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

| — | IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: Get medical advice. |
| --- | --- |

—

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: Get medical advice.

| — | IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. |
| --- | --- |

—

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 or an ambulance for medical assistance.

Information to healthcare personnel or a doctor:

| — | The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid |
| --- | --- |

—

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

| — | IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance. |
| --- | --- |

—

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

| — | IF INHALED: If symptoms occur call a POISON CENTRE or a doctor |
| --- | --- |

—

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor

5.4.   Instructions for safe disposal of the product and its packaging

| — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains. |
| --- | --- |

—

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

| — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. |
| --- | --- |

—

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

| — | Shelf-life: 2 years. |
| --- | --- |

—

Shelf-life: 2 years.

| — | Protect from frost. |
| --- | --- |

—

Protect from frost.

6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

| | EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
| --- | --- |

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

| | EN 16321 - Eye and face protection for occupational use |
| --- | --- |

EN 16321 - Eye and face protection for occupational use

| | EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) |
| --- | --- |

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM3_2 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0024 1-6 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 28,8 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,28 |

Trade name(s)

SALVE FAM3_2

Market area: EU

Authorisation number

EU-0028967-0024 1-6

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

28,8

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

5,28

META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier

| Identifier | meta-SPC7 |
| --- | --- |

Identifier

meta-SPC7

1.2.   Suffix to the authorisation number

| Number | 1-7 |
| --- | --- |

Number

1-7

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT03 - Veterinary hygiene (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 24,93 | 24,93 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 | 3,52 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

24,93

24,93

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

3,52

3,52

2.2.   Type(s) of formulation of the meta SPC 7

| Formulation(s) | SL – Soluble Concentrate |
| --- | --- |

Formulation(s)

SL – Soluble Concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

| Hazard statements | Causes skin irritation.
  Causes serious eye damage. |
| --- | --- |
| Precautionary statements | Wash hands thoroughly after handling.
  Wear protective gloves, protective clothing and eye protection.
  IF ON SKIN:Wash with plenty of water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER or doctor.
  Specific treatment (see supplemental first aid instruction on this label).
  If skin irritation occurs:Get medical advice.
  Take off contaminated clothing.And wash it before reuse. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Precautionary statements

Wash hands thoroughly after handling.

Wear protective gloves, protective clothing and eye protection.

IF ON SKIN:Wash with plenty of water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Specific treatment (see supplemental first aid instruction on this label).

If skin irritation occurs:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

4.   AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description

Table 13

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage:
  Scientific name: Viruses
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | In domestic, institutional and industrial area |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Viruses

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Outdoor

—

In domestic, institutional and industrial area

Application method(s)

Method: Wiping, moping or brush, spraying, soaking or dipping (immersion)

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeasts: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeasts: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C

Other target organisms:

| — | Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C

The concentrated product is to be diluted at 1% v/v before use.

Category(ies) of users

Professional

Pack sizes and packaging material

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

Soft container: 1,5, 2,5 liters Low density polyethylene (LDPE)

4.1.1.   Use-specific instructions for use

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected).

4.1.2.   Use-specific risk mitigation measures

See general instructions for use.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use.

4.2.   Use description

Table 14

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial (food industry) areas)

| Product type | PT04 - Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage:
  Scientific name: Virus
  Common name: Enveloped viruses only
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | In domestic, institutional and food industry areas |

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Virus

Common name: Enveloped viruses only

Development stage:

Field(s) of use

Indoor

Outdoor

—

In domestic, institutional and food industry areas

Application method(s)

Method: Wiping, moping or brush, spraying, soaking or dipping (immersion)

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,299%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeast: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Bacteria and yeast: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C

Other target organisms:

| — | Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C |
| --- | --- |

—

Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C

The concentrated product is to be diluted at 1% v/v before use as indicated on label.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

Soft container: 1,5, 2,5 liters LDPE

4.2.1.   Use-specific instructions for use

| — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected). |
| --- | --- |

—

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected).

4.2.2.   Use-specific risk mitigation measures

See general instructions for use

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

4.3.   Use description

Table 15

Use # 3 – Disinfectants used to disinfect the materials and surfaces associated with the housing of animals (disinfectants for all washable hard surfaces in veterinary area)

| Product type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeast
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Outdoor
  - |
| Application method(s) | Method: Wiping, moping or brush, spraying, soaking or dipping (immersion)
  Detailed description:






  — | without mechanical action |

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Outdoor

-

Application method(s)

Method: Wiping, moping or brush, spraying, soaking or dipping (immersion)

Detailed description:

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0,748%

Number and timing of application:

Mandatory target organisms:

| — | Bacteria and yeast: 0,748% w/w L-(+)-lactic acid, 30 minutes, 10°C |
| --- | --- |

—

Bacteria and yeast: 0,748% w/w L-(+)-lactic acid, 30 minutes, 10°C

The concentrated product is to be diluted at 2,5% v/v before use as indicated on label.

Category(ies) of users

Professional

Pack sizes and packaging material

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE

Drum: 10-210 liters HDPE

IBC: 1 000 liters HDPE

Soft container: 1,5, 2,5 liters LDPE

4.3.1.   Use-specific instructions for use

| — | Clean carefully the surfaces before application of the product. |
| --- | --- |

—

Clean carefully the surfaces before application of the product.

| — | Apply the product by fully wetting all surface for 30 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected). |
| --- | --- |

—

Apply the product by fully wetting all surface for 30 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected).

4.3.2.   Use-specific risk mitigation measures

See general instructions for use

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

5.   GENERAL DIRECTIONS FOR USE (7)
  OF THE META SPC 7

5.1.   Instructions for use

| — | Apply only on non porous surfaces. |
| --- | --- |

—

Apply only on non porous surfaces.

| — | Inform the authorisation holder if the treatment is ineffective. |
| --- | --- |

—

Inform the authorisation holder if the treatment is ineffective.

5.2.   Risk mitigation measures

| — | Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6. |
| --- | --- |

—

Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.

| — | PPE material to be specified by the authorisation holder within the product information. |
| --- | --- |

—

PPE material to be specified by the authorisation holder within the product information.

| — | Wash hands after use of the concentrate product. |
| --- | --- |

—

Wash hands after use of the concentrate product.

| — | Avoid contact with eyes. |
| --- | --- |

—

Avoid contact with eyes.

| — | Avoid splashes and spills during mixing and loading (dilution). |
| --- | --- |

—

Avoid splashes and spills during mixing and loading (dilution).

| — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. |
| --- | --- |

—

For outdoor uses, do not apply the product in case rain is expected within 24 hours.

| — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). |
| --- | --- |

—

For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

| — | IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

—

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

| — | IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. |
| --- | --- |

—

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 or an ambulance for medical assistance.

Information to healthcare personnel or a doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

| — | IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance. |
| --- | --- |

—

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

| — | IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

5.4.   Instructions for safe disposal of the product and its packaging

| — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains. |
| --- | --- |

—

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

| — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. |
| --- | --- |

—

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

| — | Shelf-life: 2 years. |
| --- | --- |

—

Shelf-life: 2 years.

| — | Protect from frost. |
| --- | --- |

—

Protect from frost.

6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

| | EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
| --- | --- |

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

| | EN 16321 - Eye and face protection for occupational use |
| --- | --- |

EN 16321 - Eye and face protection for occupational use

| | EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) |
| --- | --- |

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE 15 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0025 1-7 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 |
| Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 24,93 |
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 |

Trade name(s)

SALVE 15

Market area: EU

Authorisation number

EU-0028967-0025 1-7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

31,33

Sodium octyl ether carboxylate

Non-active substance

53563-70-5

24,93

D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides

Non-active substance

110615-47-9

3,52

META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier

| Identifier | meta-SPC8 |
| --- | --- |

Identifier

meta-SPC8

1.2.   Suffix to the authorisation number

| Number | 1-8 |
| --- | --- |

Number

1-8

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 | 1,566 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

0,627

1,566

2.2.   Type(s) of formulation of the meta SPC 8

| Formulation(s) | AL – Any other liquids |
| --- | --- |

Formulation(s)

AL – Any other liquids

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

| Hazard statements | |
| --- | --- |
| Precautionary statements | |

Hazard statements

Precautionary statements

4.   AUTHORISED USE(S) OF THE META SPC 8

4.1.   Use description

Table 16

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage:
  Scientific name: Viruses
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | In domestic, institutional and industrial areas. |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Viruses

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Outdoor

—

In domestic, institutional and industrial areas.

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0

Number and timing of application:

Ready to use products.

Contact time: 5 minutes, 20°C

Category(ies) of users

Professional

General public (non-professional)

Pack sizes and packaging material

Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle.

Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE (only for professional users)

Drum: 10-210 liters HDPE (only for professional users)

IBC: 1 000 liters HDPE (only for professional users)

4.1.1.   Use-specific instructions for use

See general instructions for use

4.1.2.   Use-specific risk mitigation measures

See general instructions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

4.2.   Use description

Table 17

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial areas)

| Product type | PT04 - Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | In domestic, institutional and industrial (food industry (general)) areas. |

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Outdoor

—

In domestic, institutional and industrial (food industry (general)) areas.

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion

Detailed description:

-

Application rate(s) and frequency

Application Rate: -

Dilution (%): 0

Number and timing of application:

Ready to use products.

Contact time: 5 minutes, 20°C

Category(ies) of users

Professional

General public (non-professional)

Pack sizes and packaging material

Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle.

Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE (only for professional users)

Drum: 10-210 liters HDPE (only for professional users)

IBC: 1 000 liters HDPE (only for professional users)

4.2.1.   Use-specific instructions for use

See general instructions for use

4.2.2.   Use-specific risk mitigation measures

See general instructions for use

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

5.   GENERAL DIRECTIONS FOR USE (8)
  OF THE META SPC 8

5.1.   Instructions for use

| — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected). |
| --- | --- |

—

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).

| — | Apply only on non porous surfaces. |
| --- | --- |

—

Apply only on non porous surfaces.

| — | Inform the authorisation holder if the treatment is ineffective. |
| --- | --- |

—

Inform the authorisation holder if the treatment is ineffective.

| — | Comply with the instructions for use. |
| --- | --- |

—

Comply with the instructions for use.

5.2.   Risk mitigation measures

| — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. |
| --- | --- |

—

For outdoor uses, do not apply the product in case rain is expected within 24 hours.

| — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). |
| --- | --- |

—

For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

| — | If medical advice is needed, have product container or label at hand |
| --- | --- |

—

If medical advice is needed, have product container or label at hand

| — | IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.

| — | IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.

| — | IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.

| — | IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

5.4.   Instructions for safe disposal of the product and its packaging

| — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains. |
| --- | --- |

—

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

| — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. |
| --- | --- |

—

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

| — | Keep out of reach of children and non-target animals or pets. |
| --- | --- |

—

Keep out of reach of children and non-target animals or pets.

| — | Shelf-life: 2 years. |
| --- | --- |

—

Shelf-life: 2 years.

| — | Protect from frost. |
| --- | --- |

—

Protect from frost.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM5_1 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0026 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 |

Trade name(s)

SALVE FAM5_1

Market area: EU

Authorisation number

EU-0028967-0026 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

0,627

7.2.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM5_2 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0027 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 |

Trade name(s)

SALVE FAM5_2

Market area: EU

Authorisation number

EU-0028967-0027 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

0,627

7.3.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SANILAK - Nettoyant désinfectant multi-usages Eucalyptus | Market area: EU |
| --- | --- | --- |
| | SANILAK - Nettoyant désinfectant sanitaires Eucalyptus | Market area: EU |
| SANILAK - Nettoyant désinfectant cuisine Eucalyptus | Market area: EU |
| SALVE FAM5_3 | Market area: EU |
| Authorisation number | EU-0028967-0028 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 |

Trade name(s)

SANILAK - Nettoyant désinfectant multi-usages Eucalyptus

Market area: EU

SANILAK - Nettoyant désinfectant sanitaires Eucalyptus

Market area: EU

SANILAK - Nettoyant désinfectant cuisine Eucalyptus

Market area: EU

SALVE FAM5_3

Market area: EU

Authorisation number

EU-0028967-0028 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

0,627

7.4.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM5_4 | Market area: EU |
| --- | --- | --- |
| | YOU - All purpose disinfecting cleaner | Market area: EU |
| MAISON VERTE - Désinfectant | Market area: EU |
| MAISON VERTE PRO - Désinfectant Multi-usages | Market area: EU |
| MAISON VERTE PRO - Désinfectant Salle de Bain | Market area: EU |
| SANIVERT - Désinfectant | Market area: EU |
| YOU - Nettoyant désinfectant toutes surfaces | Market area: EU |
| YOU - Désinfectant WC détartrant | Market area: EU |
| Authorisation number | EU-0028967-0029 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 |

Trade name(s)

SALVE FAM5_4

Market area: EU

YOU - All purpose disinfecting cleaner

Market area: EU

MAISON VERTE - Désinfectant

Market area: EU

MAISON VERTE PRO - Désinfectant Multi-usages

Market area: EU

MAISON VERTE PRO - Désinfectant Salle de Bain

Market area: EU

SANIVERT - Désinfectant

Market area: EU

YOU - Nettoyant désinfectant toutes surfaces

Market area: EU

YOU - Désinfectant WC détartrant

Market area: EU

Authorisation number

EU-0028967-0029 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

0,627

7.5.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM5_5 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0030 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,566 |

Trade name(s)

SALVE FAM5_5

Market area: EU

Authorisation number

EU-0028967-0030 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

1,566

7.6.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM5_6 | Market area: EU |
| --- | --- | --- |
| | SANILAK - Nettoyant désinfectant sols et surfaces | Market area: EU |
| Authorisation number | EU-0028967-0031 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,566 |

Trade name(s)

SALVE FAM5_6

Market area: EU

SANILAK - Nettoyant désinfectant sols et surfaces

Market area: EU

Authorisation number

EU-0028967-0031 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

1,566

7.7.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM5_7 | Market area: EU |
| --- | --- | --- |
| | SANILAK - Nettoyant désinfectant sols et surfaces Eucalyptus | Market area: EU |
| Authorisation number | EU-0028967-0032 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,566 |

Trade name(s)

SALVE FAM5_7

Market area: EU

SANILAK - Nettoyant désinfectant sols et surfaces Eucalyptus

Market area: EU

Authorisation number

EU-0028967-0032 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

1,566

7.8.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM5_8 | Market area: EU |
| --- | --- | --- |
| | MAISON VERTE - Désinfectant Multi-surfaces | Market area: EU |
| MAISON VERTE PRO - Désinfectant Sol | Market area: EU |
| MAISON VERTE PRO - Désinfectant Multi-surfaces | Market area: EU |
| SANIVERT - Désinfectant Multi-surfaces | Market area: EU |
| YOU - Désinfectant sols & surfaces | Market area: EU |
| Authorisation number | EU-0028967-0033 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,566 |

Trade name(s)

SALVE FAM5_8

Market area: EU

MAISON VERTE - Désinfectant Multi-surfaces

Market area: EU

MAISON VERTE PRO - Désinfectant Sol

Market area: EU

MAISON VERTE PRO - Désinfectant Multi-surfaces

Market area: EU

SANIVERT - Désinfectant Multi-surfaces

Market area: EU

YOU - Désinfectant sols & surfaces

Market area: EU

Authorisation number

EU-0028967-0033 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

1,566

META SPC 9

1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier

| Identifier | meta-SPC9 |
| --- | --- |

Identifier

meta-SPC9

1.2.   Suffix to the authorisation number

| Number | 1-9 |
| --- | --- |

Number

1-9

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 9 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 9

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 | 0,627 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

0,627

0,627

2.2.   Type(s) of formulation of the meta SPC 9

| Formulation(s) | AL – Any other liquids |
| --- | --- |

Formulation(s)

AL – Any other liquids

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

| Hazard statements | |
| --- | --- |
| Precautionary statements | |

Hazard statements

Precautionary statements

4.   AUTHORISED USE(S) OF THE META SPC 9

4.1.   Use description

Table 18

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage:
  Scientific name: Viruses
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | In domestic, institutional and industrial area. |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Viruses

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Outdoor

—

In domestic, institutional and industrial area.

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): -

Number and timing of application:

Ready to use products.

Contact time: 5 minutes, 20°C

Category(ies) of users

Professional

General public (non-professional)

Pack sizes and packaging material

Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle

Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE (only for professional users)

Drum: 10-210 liters HDPE (only for professional users)

4.1.1.   Use-specific instructions for use

See general instructions for use

4.1.2.   Use-specific risk mitigation measures

See general instructions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

4.2.   Use description

Table 19

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial areas)

| Product type | PT04 - Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage:
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Outdoor






  — | In domestic, institutional and industrial (general) area |

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Yeasts

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Outdoor

—

In domestic, institutional and industrial (general) area

Application method(s)

Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping

Detailed description:

| — | without mechanical action |
| --- | --- |

—

without mechanical action

Application rate(s) and frequency

Application Rate: -

Dilution (%): -

Number and timing of application:

Ready to use products.

Contact time: 5 minutes, 20°C

Category(ies) of users

Professional

General public (non-professional)

Pack sizes and packaging material

Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be eqquiped with a handle.

Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET

Bottles: 0,5 - 5 liters HDPE or PET

Jerry can: 1-80 liters HDPE (only for professional users)

Drum: 10-210 liters HDPE (only for professional users)

4.2.1.   Use-specific instructions for use

See general instructions for use

4.2.2.   Use-specific risk mitigation measures

See general instructions for use

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use

5.   GENERAL DIRECTIONS FOR USE (9)
  OF THE META SPC 9

5.1.   Instructions for use

| — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected). |
| --- | --- |

—

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).

| — | Comply with the instructions for use. |
| --- | --- |

—

Comply with the instructions for use.

| — | Apply only on non-porous surfaces |
| --- | --- |

—

Apply only on non-porous surfaces

5.2.   Risk mitigation measures

| — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. |
| --- | --- |

—

For outdoor uses, do not apply the product in case rain is expected within 24 hours.

| — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). |
| --- | --- |

—

For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

| — | If medical advice is needed, have product container or label at hand |
| --- | --- |

—

If medical advice is needed, have product container or label at hand

| — | IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.

| — | IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.

| — | IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.

| — | IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

—

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

5.4.   Instructions for safe disposal of the product and its packaging

| — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains. |
| --- | --- |

—

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

| — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. |
| --- | --- |

—

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

| — | Keep out of reach of children and non-target animals or pets. |
| --- | --- |

—

Keep out of reach of children and non-target animals or pets.

| — | Shelf-life: 2 years. |
| --- | --- |

—

Shelf-life: 2 years.

| — | Protect from frost. |
| --- | --- |

—

Protect from frost.

6.   OTHER INFORMATION

-

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM6_1 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0034 1-9 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 |

Trade name(s)

SALVE FAM6_1

Market area: EU

Authorisation number

EU-0028967-0034 1-9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

0,627

7.2.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM6_2 | Market area: EU |
| --- | --- | --- |
| | SANILAK - Nettoyant désinfectant multi-usages Menthe | Market area: EU |
| SANILAK - Nettoyant désinfectant sanitaires Menthe | Market area: EU |
| SANILAK - Nettoyant désinfectant cuisine Menthe | Market area: EU |
| Authorisation number | EU-0028967-0035 1-9 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 |

Trade name(s)

SALVE FAM6_2

Market area: EU

SANILAK - Nettoyant désinfectant multi-usages Menthe

Market area: EU

SANILAK - Nettoyant désinfectant sanitaires Menthe

Market area: EU

SANILAK - Nettoyant désinfectant cuisine Menthe

Market area: EU

Authorisation number

EU-0028967-0035 1-9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

0,627

7.3.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | SALVE FAM6_3 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028967-0036 1-9 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 |

Trade name(s)

SALVE FAM6_3

Market area: EU

Authorisation number

EU-0028967-0036 1-9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

0,627

---

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.

(6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.

(7)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.

(8)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.

(9)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.

---

DECISIONS

| 12.9.2023 | EN | Official Journal of the European Union | L 224/100 |
| --- | --- | --- | --- |

12.9.2023

EN

Official Journal of the European Union

L 224/100

---

COMMISSION IMPLEMENTING DECISION (EU) 2023/1759

of 11 September 2023

on the harmonised standards for household dishwashers drafted in support of Regulation (EU) 2019/2022 and Delegated Regulation (EU) 2019/2017

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (1), and in particular Article 10(6) thereof,

Whereas:

| (1) | In accordance with Article 9(2) of Directive 2009/125/EC of the European Parliament and of the Council (2), Member States are to regard a product for which harmonised standards have been applied, the reference numbers of which have been published in the Official Journal of the European Union, as conforming to all the relevant requirements of the applicable implementing measure to which such standards relate. Article 4 of Commission Regulation (EU) 2019/2022 (3) and Annex III thereto lay down the relevant measurement and calculation requirements for household dishwashers. Annex III to Regulation (EU) 2019/2022 was amended by Commission Regulation (EU) 2021/341 (4). |
| --- | --- |

(1)

In accordance with Article 9(2) of Directive 2009/125/EC of the European Parliament and of the Council (2), Member States are to regard a product for which harmonised standards have been applied, the reference numbers of which have been published in the Official Journal of the European Union, as conforming to all the relevant requirements of the applicable implementing measure to which such standards relate. Article 4 of Commission Regulation (EU) 2019/2022 (3) and Annex III thereto lay down the relevant measurement and calculation requirements for household dishwashers. Annex III to Regulation (EU) 2019/2022 was amended by Commission Regulation (EU) 2021/341 (4).

| (2) | In accordance with Article 13 of Regulation (EU) 2017/1369 of the European Parliament and of the Council (5) after the adoption of a delegated act pursuant to Article 16 of that Regulation setting specific labelling requirements the Commission is to publish references to the harmonised standards that satisfy the relevant measurement and calculation requirements of the delegated act in the Official Journal of the European Union. Where such harmonised standards are applied during the conformity assessment of a product, the model is to be presumed to be in conformity with the relevant measurement and calculation requirements of the delegated act. Article 3 of Commission Delegated Regulation (EU) 2019/2017 (6) and Annex IV thereto lay down measurement and calculation requirements for household dishwashers. Annex IV to Delegated Regulation (EU) 2019/2017 was amended by Commission Delegated Regulation (EU) 2021/340 (7). |
| --- | --- |

(2)

In accordance with Article 13 of Regulation (EU) 2017/1369 of the European Parliament and of the Council (5) after the adoption of a delegated act pursuant to Article 16 of that Regulation setting specific labelling requirements the Commission is to publish references to the harmonised standards that satisfy the relevant measurement and calculation requirements of the delegated act in the Official Journal of the European Union. Where such harmonised standards are applied during the conformity assessment of a product, the model is to be presumed to be in conformity with the relevant measurement and calculation requirements of the delegated act. Article 3 of Commission Delegated Regulation (EU) 2019/2017 (6) and Annex IV thereto lay down measurement and calculation requirements for household dishwashers. Annex IV to Delegated Regulation (EU) 2019/2017 was amended by Commission Delegated Regulation (EU) 2021/340 (7).

| (3) | By Implementing Decision C(2020) 4329 (8), the Commission made a request to the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (Cenelec) and the European Telecommunications Standards Institute (ETSI) to revise existing harmonised standards on household dishwashers, household washing machines and household washer-dryers in support of Regulation (EU) 2019/2022 and Commission Regulation (EU) 2019/2023 (9), Delegated Regulation (EU) 2019/2017 and Commission Delegated Regulation (EU) 2019/2014 (10). |
| --- | --- |

(3)

By Implementing Decision C(2020) 4329 (8), the Commission made a request to the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (Cenelec) and the European Telecommunications Standards Institute (ETSI) to revise existing harmonised standards on household dishwashers, household washing machines and household washer-dryers in support of Regulation (EU) 2019/2022 and Commission Regulation (EU) 2019/2023 (9), Delegated Regulation (EU) 2019/2017 and Commission Delegated Regulation (EU) 2019/2014 (10).

| (4) | On the basis of the request set out in Implementing Decision C(2020) 4329, Cenelec revised the harmonised standard EN 60436:2020 as amended by EN 60436:2020/A11:2020 and corrected by EN 60436:2020/AC:2020-06 in order to take account of the technical and scientific progress, bring editorial changes, and align rounding of reported numbers in alignment with amendments made by Regulation (EU) 2021/341 and Delegated Regulation (EU) 2021/340. This resulted in the adoption of amendment EN 60436:2020/A12:2022 to that harmonised standard. |
| --- | --- |

(4)

On the basis of the request set out in Implementing Decision C(2020) 4329, Cenelec revised the harmonised standard EN 60436:2020 as amended by EN 60436:2020/A11:2020 and corrected by EN 60436:2020/AC:2020-06 in order to take account of the technical and scientific progress, bring editorial changes, and align rounding of reported numbers in alignment with amendments made by Regulation (EU) 2021/341 and Delegated Regulation (EU) 2021/340. This resulted in the adoption of amendment EN 60436:2020/A12:2022 to that harmonised standard.

| (5) | The Commission, together with Cenelec, has assessed whether amendment EN 60436:2020/A12:2022 to the harmonised standard EN 60436:2020 as amended by EN 60436:2020/A11:2020 and corrected by EN 60436:2020/AC:2020-06 complies with the request set out in Implementing Decision C(2020) 4329. |
| --- | --- |

(5)

The Commission, together with Cenelec, has assessed whether amendment EN 60436:2020/A12:2022 to the harmonised standard EN 60436:2020 as amended by EN 60436:2020/A11:2020 and corrected by EN 60436:2020/AC:2020-06 complies with the request set out in Implementing Decision C(2020) 4329.

| (6) | The harmonised standard EN 60436:2020, as amended by EN 60436:2020/A11:2020 and EN 60436:2020/A12:2022 and corrected by EN 60436:2020/AC:2020-06, satisfies the requirements which it aims to cover and which are set out in Regulation (EU) 2019/2022 and Delegated Regulation (EU) 2019/2017. |
| --- | --- |

(6)

The harmonised standard EN 60436:2020, as amended by EN 60436:2020/A11:2020 and EN 60436:2020/A12:2022 and corrected by EN 60436:2020/AC:2020-06, satisfies the requirements which it aims to cover and which are set out in Regulation (EU) 2019/2022 and Delegated Regulation (EU) 2019/2017.

| (7) | It is therefore appropriate to publish the reference of harmonised standard EN 60436:2020, as amended by EN 60436:2020/A11:2020 and EN 60436:2020/A12:2022 and corrected by EN 60436:2020/AC:2020-06 in the Official Journal of the European Union. |
| --- | --- |

(7)

It is therefore appropriate to publish the reference of harmonised standard EN 60436:2020, as amended by EN 60436:2020/A11:2020 and EN 60436:2020/A12:2022 and corrected by EN 60436:2020/AC:2020-06 in the Official Journal of the European Union.

| (8) | Harmonised standard EN 60436:2020, as amended by EN 60436:2020/A11:2020 and EN 60436:2020/A12:2022 and corrected by EN 60436:2020/AC:2020-06 replaces harmonised standard EN 60436:2020, as amended by EN 60436:2020/A11:2020 and corrected by EN 60436:2020/AC:2020-6. It is therefore necessary to withdraw the reference of that standard from the Official Journal of the European Union. |
| --- | --- |

(8)

Harmonised standard EN 60436:2020, as amended by EN 60436:2020/A11:2020 and EN 60436:2020/A12:2022 and corrected by EN 60436:2020/AC:2020-06 replaces harmonised standard EN 60436:2020, as amended by EN 60436:2020/A11:2020 and corrected by EN 60436:2020/AC:2020-6. It is therefore necessary to withdraw the reference of that standard from the Official Journal of the European Union.

| (9) | The references of harmonised standards drafted in support of Delegated Regulation (EU) 2019/2017 and Regulation (EU) 2019/2022 are currently published by Commission Implementing Decision (EU) 2021/913 (11) with restrictions. In view of the amendment EN 60436:2020/A12:2022 those restrictions are no longer necessary. |
| --- | --- |

(9)

The references of harmonised standards drafted in support of Delegated Regulation (EU) 2019/2017 and Regulation (EU) 2019/2022 are currently published by Commission Implementing Decision (EU) 2021/913 (11) with restrictions. In view of the amendment EN 60436:2020/A12:2022 those restrictions are no longer necessary.

| (10) | Since a number of substantial amendments are to be made to Implementing Decision (EU) 2021/913, it should be replaced in the interest of clarity. |
| --- | --- |

(10)

Since a number of substantial amendments are to be made to Implementing Decision (EU) 2021/913, it should be replaced in the interest of clarity.

| (11) | Compliance with a harmonised standard confers a presumption of conformity with the corresponding requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication, |
| --- | --- |

(11)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication,

HAS ADOPTED THIS DECISION:

Article 1

The reference to harmonised standard for energy labelling of household dishwashers drafted in support of Delegated Regulation (EU) 2019/2017 and listed in Annex I to this Decision is hereby published in the Official Journal of the European Union.

The reference to harmonised standard on ecodesign of household dishwashers drafted in support of Regulation (EU) 2019/2022 and listed in Annex II to this Decision is hereby published in the Official Journal of the European Union.

Article 2

Implementing Decision (EU) 2021/913 is repealed.

Article 3

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

Done at Brussels, 11 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 316, 14.11.2012, p. 12.

1

(2)  Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10).

2

(3)  Commission Regulation (EU) 2019/2022 of 1 October 2019 laying down ecodesign requirements for household dishwashers pursuant to Directive 2009/125/EC of the European Parliament and of the Council amending Commission Regulation (EC) No 1275/2008 and repealing Commission Regulation (EU) No 1016/2010 (OJ L 315, 5.12.2019, p. 267).

3

(4)  Commission Regulation (EU) 2021/341 of 23 February 2021 amending Regulations (EU) 2019/424, (EU) 2019/1781, (EU) 2019/2019, (EU) 2019/2020, (EU) 2019/2021, (EU) 2019/2022, (EU) 2019/2023 and (EU) 2019/2024 with regard to ecodesign requirements for servers and data storage products, electric motors and variable speed drives, refrigerating appliances, light sources and separate control gears, electronic displays, household dishwashers, household washing machines and household washer-dryers and refrigerating appliances with a direct sales function (OJ L 68, 26.2.2021, p. 108).

4

(5)  Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1).

5

(6)  Commission Delegated Regulation (EU) 2019/2017 of 11 March 2019 supplementing Regulation (EU) 2017/1369 of the European Parliament and of the Council with regard to energy labelling of household dishwashers and repealing Commission Delegated Regulation (EU) No 1059/2010 (OJ L 315, 5.12.2019, p. 134).

6

(7)  Commission Delegated Regulation (EU) 2021/340 of 17 December 2020 amending Delegated Regulations (EU) 2019/2013, (EU) 2019/2014, (EU) 2019/2015, (EU) 2019/2016, (EU) 2019/2017 and (EU) 2019/2018 with regard to energy labelling requirements for electronic displays, household washing machines and household washer-dryers, light sources, refrigerating appliances, household dishwashers, and refrigerating appliances with a direct sales function (OJ L 68, 26.2.2021, p. 62).

7

(8)  Commission Implementing Decision C(2020)4329 of 1 July 2020 on a standardisation request to the European Committee for Standardisation, the European Committee for Electrotechnical Standardisation and the European Telecommunications Standards Institute as regards ecodesign and energy labelling requirements for household dishwashers, household washing machines and household washer-dryers in support of Commission Regulations (EU) 2019/2022 and (EU) 2019/2023 and Commission Delegated Regulations (EU) 2019/2017 and (EU) 2019/2014.

8

(9)  Commission Regulation (EU) 2019/2023 of 1 October 2019 laying down ecodesign requirements for household washing machines and household washer-dryers pursuant to Directive 2009/125/EC of the European Parliament and of the Council, amending Commission Regulation (EC) No 1275/2008 and repealing Commission Regulation (EU) No 1015/2010 (OJ L 315, 5.12.2019, p. 285).

9

(10)  Commission Delegated Regulation (EU) 2019/2014 of 11 March 2019 supplementing Regulation (EU) 2017/1369 of the European Parliament and of the Council with regard to energy labelling of household washing machines and household washer-dryers and repealing Commission Delegated Regulation (EU) No 1061/2010 and Commission Directive 96/60/EC (OJ L 315, 5.12.2019, p. 29).

10

(11)  Commission Implementing Decision (EU) 2021/913 of 3 June 2021 on the harmonised standards for household dishwashers drafted in support of Regulation (EU) 2019/2022 and Delegated Regulation (EU) 2019/2017 (OJ L 199, 7.6.2021, p. 13).

11

---

ANNEX I

Reference of the harmonised standard drafted in support of Delegated Regulation (EU) 2019/2017

| EN 60436:2020
  Electric dishwashers for household use – Methods for measuring the performance
  EN 60436:2020/A11:2020
  EN 60436:2020/AC:2020-06
  EN 60436:2020/A12:2022 |
| --- |

EN 60436:2020

Electric dishwashers for household use – Methods for measuring the performance

EN 60436:2020/A11:2020

EN 60436:2020/AC:2020-06

EN 60436:2020/A12:2022

---

ANNEX II

Reference of the harmonised standard drafted in support of Regulation (EU) 2019/2022

| EN 60436:2020
  Electric dishwashers for household use – Methods for measuring the performance
  EN 60436:2020/A11:2020
  EN 60436:2020/AC:2020-06
  EN 60436:2020/A12:2022 |
| --- |

EN 60436:2020

Electric dishwashers for household use – Methods for measuring the performance

EN 60436:2020/A11:2020

EN 60436:2020/AC:2020-06

EN 60436:2020/A12:2022

---

| 12.9.2023 | EN | Official Journal of the European Union | L 224/105 |
| --- | --- | --- | --- |

12.9.2023

EN

Official Journal of the European Union

L 224/105

---

COMMISSION IMPLEMENTING DECISION (EU) 2023/1760

of 11 September 2023

on the recognition of the report including information on the typical greenhouse gas emissions from the cultivation of canola oilseed (rapeseed) in Australia under Article 31(3) and (4) of Directive (EU) 2018/2001 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (1), and in particular Article 31(4) thereof,

Whereas:

| (1) | Directive (EU) 2018/2001 sets out that biofuels, bioliquids, and biomass fuels have to save significant greenhouse gas emissions compared to fossil fuels so that they can be counted towards the targets set in that Directive. For that purpose, Article 29(10) sets specific emission savings thresholds for those fuels, and Article 31 sets out how to calculate the greenhouse gas emission savings from their use. When making those calculations, it is possible to use the default values set out in Annexes V and VI to Directive (EU) 2018/2001. Instead of the default values of greenhouse gas emissions from cultivating agricultural raw materials, it is possible to use typical values under some conditions. Those typical values, representing the average value in a specific area, may be reported to the Commission by Member States or third countries. The typical values may only be used if the Commission recognises them to be accurate. |
| --- | --- |

(1)

Directive (EU) 2018/2001 sets out that biofuels, bioliquids, and biomass fuels have to save significant greenhouse gas emissions compared to fossil fuels so that they can be counted towards the targets set in that Directive. For that purpose, Article 29(10) sets specific emission savings thresholds for those fuels, and Article 31 sets out how to calculate the greenhouse gas emission savings from their use. When making those calculations, it is possible to use the default values set out in Annexes V and VI to Directive (EU) 2018/2001. Instead of the default values of greenhouse gas emissions from cultivating agricultural raw materials, it is possible to use typical values under some conditions. Those typical values, representing the average value in a specific area, may be reported to the Commission by Member States or third countries. The typical values may only be used if the Commission recognises them to be accurate.

| (2) | On 18 May 2023, Australia sent the Commission the final report with data for the purposes of measuring the greenhouse gas emissions associated with the cultivating canola oilseed (rapeseed) typically produced in regions in Australia equivalent to NUTS 2 (2) regions of the Union, asking for the recognition of the accuracy of such data in line with Article 31(4) of Directive (EU) 2018/2001. |
| --- | --- |

(2)

On 18 May 2023, Australia sent the Commission the final report with data for the purposes of measuring the greenhouse gas emissions associated with the cultivating canola oilseed (rapeseed) typically produced in regions in Australia equivalent to NUTS 2 (2) regions of the Union, asking for the recognition of the accuracy of such data in line with Article 31(4) of Directive (EU) 2018/2001.

| (3) | The Commission assessed the report and found that it contains accurate data for the purposes of measuring the greenhouse gas emissions associated with cultivating canola oilseed (rapeseed) typically produced in regions in Australia equivalent to NUTS 2 regions of the Union. |
| --- | --- |

(3)

The Commission assessed the report and found that it contains accurate data for the purposes of measuring the greenhouse gas emissions associated with cultivating canola oilseed (rapeseed) typically produced in regions in Australia equivalent to NUTS 2 regions of the Union.

| (4) | The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels, |
| --- | --- |

(4)

The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels,

HAS ADOPTED THIS DECISION:

Article 1

The report submitted for recognition to the Commission by Australia on 18 May 2023 contains accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of canola oilseed (rapeseed) typically produced in regions in Australia equivalent to NUTS 2 regions of the Union, pursuant to Article 31(4) of Directive (EU) 2018/2001. The summary of the report’s data is set out in the Annex.

Article 2

This Decision is valid for a period of five years after the date of its entry into force. If the content of the report, as submitted for recognition to the Commission on 18 May 2023, changes in a way that might affect the basis of this Decision, such changes shall be notified to the Commission immediately. The Commission shall assess the notified changes to determine whether the report still provides accurate data for which it is recognised.

Article 3

The Commission may repeal this Decision if it has been clearly demonstrated that the report no longer contains accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of canola oilseed (rapeseed) produced in Australia.

Article 4

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 11 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 328, 21.12.2018, p. 82.

1

(2)  NUTS is a classification system for EU territorial units for statistics.

2

---

ANNEX

Greenhouse gas emissions arising from the cultivation of canola oilseed (rapeseed) in the States of Australia (tonne CO2-eq/tonne canola seed harvested on dry matter basis)

| | Soil N2O | Crop residue | Embedded | Fuel use | Fertiliser acidification | Seed | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Direct | Indirect | | Fertiliser | Pesticide | Lime | | | | |
| New South Wales | 0,060 | 0,015 | 0,056 | 0,229 | 0,038 | 0,002 | 0,065 | 0,041 | 0,002 | 0,508 |
| Single purpose | 0,057 | 0,011 | 0,066 | 0,248 | 0,047 | 0,002 | 0,075 | 0,044 | 0,002 | 0,554 |
| Dual purpose | 0,039 | 0,007 | 0,026 | 0,162 | 0,018 | 0,001 | 0,029 | 0,028 | 0,002 | 0,313 |
| Irrigated | 0,261 | 0,136 | 0,066 | 0,327 | 0,007 | 0,003 | 0,096 | 0,058 | 0,001 | 0,954 |
| Victoria | 0,023 | 0,009 | 0,062 | 0,221 | 0,036 | 0,002 | 0,050 | 0,040 | 0,002 | 0,444 |
| Single purpose | 0,024 | 0,009 | 0,065 | 0,226 | 0,038 | 0,002 | 0,052 | 0,041 | 0,002 | 0,458 |
| Dual purpose | 0,017 | 0,006 | 0,030 | 0,161 | 0,017 | 0,001 | 0,024 | 0,029 | 0,002 | 0,288 |
| Queensland | 0,061 | 0,008 | 0,063 | 0,239 | 0,054 | 0,002 | 0,167 | 0,043 | 0,003 | 0,641 |
| South Australia | 0,016 | 0,004 | 0,059 | 0,214 | 0,068 | 0,002 | 0,062 | 0,039 | 0,002 | 0,466 |
| Single purpose | 0,012 | 0,002 | 0,061 | 0,216 | 0,071 | 0,002 | 0,064 | 0,039 | 0,002 | 0,469 |
| Dual purpose | 0,009 | 0,001 | 0,028 | 0,155 | 0,032 | 0,001 | 0,029 | 0,028 | 0,002 | 0,285 |
| Irrigated | 0,232 | 0,125 | 0,061 | 0,288 | 0,007 | 0,003 | 0,096 | 0,052 | 0,001 | 0,865 |
| Western Australia | 0,014 | 0,003 | 0,058 | 0,225 | 0,030 | 0,002 | 0,069 | 0,037 | 0,002 | 0,441 |
| Single purpose | 0,014 | 0,003 | 0,059 | 0,225 | 0,031 | 0,002 | 0,069 | 0,037 | 0,002 | 0,441 |
| Dual purpose | 0,010 | 0,002 | 0,023 | 0,159 | 0,012 | 0,001 | 0,027 | 0,026 | 0,002 | 0,263 |
| Tasmania* | 0,240 | 0,127 | 0,057 | 0,298 | 0,013 | 0,003 | 0,079 | 0,054 | 0,001 | 0,873 |

Soil N2O

Crop residue

Embedded

Fuel use

Fertiliser acidification

Seed

Total

Direct

Indirect

Fertiliser

Pesticide

Lime

New South Wales

0,060

0,015

0,056

0,229

0,038

0,002

0,065

0,041

0,002

0,508

Single purpose

0,057

0,011

0,066

0,248

0,047

0,002

0,075

0,044

0,002

0,554

Dual purpose

0,039

0,007

0,026

0,162

0,018

0,001

0,029

0,028

0,002

0,313

Irrigated

0,261

0,136

0,066

0,327

0,007

0,003

0,096

0,058

0,001

0,954

Victoria

0,023

0,009

0,062

0,221

0,036

0,002

0,050

0,040

0,002

0,444

Single purpose

0,024

0,009

0,065

0,226

0,038

0,002

0,052

0,041

0,002

0,458

Dual purpose

0,017

0,006

0,030

0,161

0,017

0,001

0,024

0,029

0,002

0,288

Queensland

0,061

0,008

0,063

0,239

0,054

0,002

0,167

0,043

0,003

0,641

South Australia

0,016

0,004

0,059

0,214

0,068

0,002

0,062

0,039

0,002

0,466

Single purpose

0,012

0,002

0,061

0,216

0,071

0,002

0,064

0,039

0,002

0,469

Dual purpose

0,009

0,001

0,028

0,155

0,032

0,001

0,029

0,028

0,002

0,285

Irrigated

0,232

0,125

0,061

0,288

0,007

0,003

0,096

0,052

0,001

0,865

Western Australia

0,014

0,003

0,058

0,225

0,030

0,002

0,069

0,037

0,002

0,441

Single purpose

0,014

0,003

0,059

0,225

0,031

0,002

0,069

0,037

0,002

0,441

Dual purpose

0,010

0,002

0,023

0,159

0,012

0,001

0,027

0,026

0,002

0,263

Tasmania*

0,240

0,127

0,057

0,298

0,013

0,003

0,079

0,054

0,001

0,873

---