Official Journal
of the European Union
EN
L series
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Official Journal |
EN L series |
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2025/831 |
6.5.2025 |
COMMISSION IMPLEMENTING REGULATION (EU) 2025/831
of 5 May 2025
granting a Union authorisation for the biocidal product family ‘AWPF Calcium Hypochlorite BPF’ 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:
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(1) |
On 13 December 2018, Innovative Water Care Europe SAS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘AWPF Calcium Hypochlorite BPF’ of product-types 2, 4 and 5, 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-WK046289-14 in the Register for Biocidal Products. |
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(2) |
‘AWPF Calcium Hypochlorite BPF’ contains active chlorine released from calcium hypochlorite as the active substance, which is included in the Union list of approved active substance referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2, 4 and 5. |
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(3) |
On 23 June 2021, 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. |
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(4) |
On 4 November 2021, the Agency submitted its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘AWPF Calcium Hypochlorite BPF’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
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(5) |
The opinion concludes that ‘AWPF Calcium Hypochlorite BPF’ 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(6) of that Regulation. |
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(6) |
On 22 November 2021, 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. |
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(7) |
On 14 July 2022, Germany sent a request to the Commission to adjust the terms and conditions of the Union authorisation of the biocidal product family ‘AWPF Calcium Hypochlorite BPF’ for its territory in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012 for use 1 in meta SPC 1, 2 and 3 (Disinfection of swimming pools and spas – professional user), use 4 (Disinfection of drinking water for human consumption in public distribution systems and portable devices – professional) and use 5 (Disinfection of drinking water for human consumption in public distribution systems and portable devices (automated feeder) – industrial user) on the grounds of the protection of the environment, public policy and the protection of health and life of humans as referred to in Article 37(1), points (a) to (c), of that Regulation. On 8 May 2024, Germany withdrew the request concerning the adjustments to use 1 in meta SPC 1, 2 and 3 (Disinfection of swimming pools and spas – professional user). |
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(8) |
In its request for the adjustments to uses 4 and 5 in meta SPC 1, 2 and 3, Germany refers to the German Ordinance on the Quality of Water Intended for Human Consumption, Trinkwasserverordnung (TrinkwV) (3) establishing a systematic set of rules to ensure healthy and clean drinking water by regulating the required quality of water, and the substances, methods and procedures to be used for the treatment of drinking water, imposing obligations on water treatment plants and setting rules on the enforcement of those obligations. Based on the TrinkwV, certain well-established norms and common practices have been developed in the drinking water treatment sector in Germany. Germany explained that for the disinfection of drinking water, part of the description of uses 4 and 5 in meta-SPCs 1, 2 and 3 of ‘AWPF Calcium Hypochlorite BPF’ does not fully correspond to the rules of the TrinkwV. For uses 4 and 5 in meta-SPC 1, the application methods and application rates and frequency for those uses would need to be adapted to meet the requirements of the list of treatment substances and disinfection processes according to Section 20 of the TrinkwV. For uses 4 and 5 in meta-SPC 2 and 3, the minimum concentration of active chlorine by weight in the biocidal product is not met and the anti-scaling agent, pigment and processing-aid are not mentioned in the list of authorised treatment substances and disinfection processes of Section 20 of the TrinkwV, which means that the products cannot be allowed in the territory of Germany for the disinfection of drinking water. |
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(9) |
The Commission, also having regard to Article 2(7) of Regulation (EU) No 528/2012, considers that the request made by Germany to adjust the conditions of the Union authorisation of the biocidal product family ‘AWPF Calcium Hypochlorite BPF’ for its territory in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012 is justified on the grounds of public policy in the supply of drinking water and the protection of health and life of humans pursuant to Article 37(1), points (b) and (c), respectively, of that Regulation. The TrinkwV transposes Directive (EU) 2020/2184 of the European Parliament and of the Council (4) into German law. That Directive sets a legal framework to protect human health from the adverse effects of any contamination of water intended for human consumption by ensuring that it is wholesome and clean. That Directive also sets essential quality standards at Union level and allows Member States to implement additional requirements and higher standards where the protection of human health within its national territory or part of it so requires. The TrinkwV is in force in Germany since 2001 and its requirements have been relied upon by the drinking water treatment sector in Germany since then. Products for the disinfection of drinking water made available on the German market should comply with the rules established in the TrinkwV. |
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(10) |
In its opinion, the Agency recommends that the authorisation holder conducts a long-term storage stability test of a product in meta-SPC 4 in the commercial packaging in which the products are to be made available on the market, as a condition in the authorisation. The test should address the relevant physical, chemical and technical properties of that product both prior to and after storage to confirm a shelf life of 12 months. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family ‘AWPF Calcium Hypochlorite BPF’ pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on the existing data. |
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(11) |
The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘AWPF Calcium Hypochlorite BPF’ with the adjustments of the SPC as requested by Germany for its territory for the uses 4 and 5 in meta-SPCs 1, 2 and 3 in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012. |
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(12) |
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-0027464-0000 is granted to Innovative Water Care Europe SAS for the making available on the market and use of the biocidal product family ‘AWPF Calcium Hypochlorite BPF’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.
For the territory of Germany, adjustments to the terms and conditions apply for the uses 4 and 5 in meta-SPCs 1, 2 and 3 as laid down in the summary of product characteristics in Annex II.
The Union Authorisation is valid from 26 May 2025 to 30 April 2035.
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, 5 May 2025.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) ECHA opinion of 6 October 2021 on the Union authorisation of ‘AWPF Calcium Hypochlorite BPF’ (ECHA/BPC/289/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation.
(3) German Ordinance on the Quality of Water Intended for Human Consumption – Verordnung über die Qualität von Wasser für den menschlichen Gebrauch (Trinkwasserverordnung – TrinkwV) in the version of the Second Ordinance for the Revision of the Drinking water Ordinance (Zweite Verordnung zur Novellierung der Trinkwasserverordnung vom 20. Juni 2023 (Bundesgesetzblatt I Nr. 159), https://www.gesetze-im-internet.de/englisch_trinkwv/englisch_trinkwv.pdf.
(4) Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23/12/2020, p. 1, ELI: http://data.europa.eu/eli/dir/2020/2184/oj).
ANNEX I
TERMS AND CONDITIONS (EU-0027465-0000)
The authorisation holder shall conduct a long-term storage stability test for a product in meta SPC 4 of ‘AWPF Calcium Hypochlorite BPF’ to confirm a shelf-life of 12 months at ambient temperature. The test shall be performed in the commercial packaging in which the products are to be made available on the market and address the relevant physical, chemical and technical properties of that product both prior to and after storage.
By 26 May 2027 the authorisation holder shall submit the results of the test to the Agency.
ANNEX II
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
AWPF Calcium Hypochlorite BPF
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
PT05: Drinking water
Authorisation number EU-0027464-0000
R4BP asset number EU-0027464-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
|
Name |
AWPF Calcium Hypochlorite BPF |
1.2. Product type(s)
|
Product type(s) |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT05: Drinking water |
1.3. Authorisation holder
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Name and address of the authorisation holder |
Name |
Innovative Water Care Europe SAS |
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Address |
ZI de la Boitardiere chemin du Roi 37400 AMBOISE FR |
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Authorisation number |
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EU-0027464-0000 |
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R4BP asset number |
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EU-0027464-0000 |
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Date of the authorisation |
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26 May 2025 |
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Expiry date of the authorisation |
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30 April 2035 |
1.4. Manufacturer(s) of the product
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Name of manufacturer |
Innovative Water Care Europe SAS |
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Address of manufacturer |
ZI LA BOITARDIERE, BP 219 37402 Amboise France |
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Location of manufacturing sites |
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1.5. Manufacturer(s) of the active substance(s)
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Active substance |
Active chlorine released from calcium hypochlorite |
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Name of manufacturer |
Innovative Water Care Europe SAS |
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Address of manufacturer |
ZI LA BOITARDIERE, BP19 37402 AMBOISE France |
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Location of manufacturing sites |
|
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Active chlorine released from calcium hypochlorite |
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active substance |
|
|
40,3 - 65 % (w/w) |
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Calcium hypochlorite |
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releaser |
7778-54-3 |
231-908-7 |
62 - 100 % (w/w) |
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Calcium dihydroxide |
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Non-Active substance |
1305-62-0 |
215-137-3 |
0 - 11 % (w/w) |
2.2. Type(s) of formulation
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Formulation type(s) |
SG Water soluble granule ST Water soluble tablet |
PART II
SECOND INFORMATION LEVEL – META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
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Identifier |
Meta SPC: meta-SPC 1 (Water soluble granules) |
1.2. Suffix to the authorisation number
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Number |
1-1 |
1.3. Product type(s)
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Product type(s) |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT05: Drinking water |
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 (%) |
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
65 - 65 % (w/w) |
|
Calcium hypochlorite |
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releaser |
7778-54-3 |
231-908-7 |
100 - 100 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 1
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Formulation type(s) |
SG Water soluble granule |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
|
Hazard statements |
H272: May intensify fire; oxidiser. H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H400: Very toxic to aquatic life. EUH031: Contact with acids liberates toxic gas. EUH206: Warning! Do not use together with other products. May release dangerous gases (chlorine). EUH071: Corrosive to the respiratory tract. |
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Precautionary statements |
P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P260: Do not breathe dust. P260: Do not breathe fume. P260: Do not breathe gas. P260: Do not breathe mist. P260: Do not breathe vapours. P260: Do not breathe spray. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or a doctor. P363: Wash contaminated clothing before reuse. P370+P378: In case of fire: Use water spray to extinguish. P391: Collect spillage. P501: Dispose of contents in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
use # 1-1 PT 2 – Disinfection of swimming pools and spas – professional user
|
Product type |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
||||||||
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Where relevant, an exact description of the authorised use |
Not relevant |
||||||||
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Target organism(s) (including development stage) |
Scientific name: Bacteria (including L. pneumophila) Common name: Bacteria (including L. pneumophila) Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
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|
Field(s) of use |
indoor use outdoor use |
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Application method(s) |
Method: Direct addition of the product to the water surface, injection of a stock solution from a tank or from an automated feeder connected to the swimming pool or spa. Detailed description: |
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Application rate(s) and frequency |
Application rate: Maintenance: 1-3 mg/l of available chlorine in water (swimming pool), 2,5 to 4 mg/l of available chlorine in water (spas); Shock treatment: 10 mg/l of available chlorine in water. Number and timing of application: Maintenance of swimming pools: Apply the product as needed to maintain a concentration between 1 and 3 mg/l of available chlorine in water. Maintenance of spas: Apply the product as needed to maintain a concentration between 2,5 up to 4 mg/l of available chlorine in water. Shock treatment of swimming pools and spas: Apply the product as to reach a concentration of 10 mg/l of available chlorine in water (contact time: 10 minutes). |
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Category(ies) of users |
professional |
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Pack sizes and packaging material |
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4.1.1. Use-specific instructions
-
4.1.2. Use-specific risk mitigation measures
|
— |
Application of this product is exclusively allowed in swimming pools with connection to a sewage treatment plant. It is not allowed to directly discharge swimming pool water to the surface water. |
|
— |
Treatment must be made in absence of bathers for shock treatment and until complete dissolution of the product for direct application for maintenance treatment. |
|
— |
Do not allow entrance to the pool until the concentration decreases back to 3 mg/l of available chlorine for swimming pools and 4 mg/l of available chlorine for spas or to national chlorine limit. |
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 direction for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction 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 direction for use.
4.2. Use description
Table 2
use # 1-2 PT 2 – Disinfection of swimming pools and spas – non-professional user
|
Product type |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
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Where relevant, an exact description of the authorised use |
Not relevant. |
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Target organism(s) (including development stage) |
Scientific name: Bacteria (including L. pneumophila) Common name: Bacteria (including L. pneumophila) Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
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Field(s) of use |
indoor use outdoor use |
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|
Application method(s) |
Method: Direct addition of the product to the water surface, e.g. with a scoop or similar. Detailed description: |
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|
Application rate(s) and frequency |
Application rate: Shock treatment: 10 mg/l of available chlorine in water Number and timing of application: Apply the product as to reach a concentration of 10 mg/l of available chlorine in water (contact time: 10 minutes), pH 6,32-7,82. |
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Category(ies) of users |
general public (non-professional) |
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Pack sizes and packaging material |
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4.2.1. Use-specific instructions
|
— |
Read label before use. |
|
— |
Check regularly chlorine content in the pools as UV could partially degrade chlorine. |
|
— |
Ensure complete mixing of the product to water. |
4.2.2. Use-specific risk mitigation measures
|
— |
Use the dosing device, scoop or similar to transfer the product. This tool must be provided with the packaging and must not be in contact with the product (must not be stored inside the packaging). Decanting has to be avoided. |
|
— |
Treatment must be made in absence of bathers. |
|
— |
Do not allow entrance to the pool until the concentration decreases back to 3 mg/l of available chlorine in water for swimming pools and 4 mg/l of available chlorine in water for spas or to national chlorine limit. |
|
— |
Application of this product is exclusively allowed in swimming pools with connection to a sewage treatment plant. It is not allowed to directly discharge swimming pool water to the surface water. |
|
— |
Washing of hands after use. |
|
— |
Washing of face/ eye after accidental exposure. |
|
— |
Avoid contact with skin and eyes. |
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
|
— |
If medical advice is needed, have product container or label at hand. |
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction 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
|
— |
Keep out of reach of children. |
4.3. Use description
Table 3
use # 1-3 PT 4 – Disinfection of equipment, containers, pipework associated with drinking water for human consumption by filling/CIP with circulation – professional user
|
Product type |
PT04: Food and feed area |
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|
Where relevant, an exact description of the authorised use |
Disinfection of interior surfaces of drinking water systems such as equipment, containers, pipework by filling/CIP with circulation. |
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|
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: no data |
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|
Field(s) of use |
indoor use |
||||||||||
|
Application method(s) |
Method: Filling of piping with stock solution. Detailed description: |
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|
Application rate(s) and frequency |
Application rate: 100 mg/l of available chlorine in water Number and timing of application: Dissolve 130 g of product into water per cubic meter of the piping to be chlorinated to reach 100 mg/l active chlorine in water. Contact time: 12 hours |
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Category(ies) of users |
professional |
||||||||||
|
Pack sizes and packaging material |
|
4.3.1. Use-specific instructions
|
— |
Clean carefully the surfaces before application of the product. |
4.3.2. Use-specific risk mitigation measures
|
— |
Ensure that the concentration of chlorine in drinking water does not exceed national chlorine limit before consumption. |
|
— |
Ensure that the concentration of chlorate present in drinking water does not exceed the parametric values set in Directive 2020/2184. |
|
— |
For food commodities, make sure that the concentration of chlorate present in food does not exceed the maximum residue levels set in Annex III of Regulation (EC) No 396/2005. |
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 direction for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction 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 direction for use.
4.4. Use description
Table 4
use # 1-4 PT 5 – Disinfection of drinking water for human consumption in public distribution systems and portable devices – professional
|
Product type |
PT05: Drinking water |
||||||||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||||||||
|
Field(s) of use |
indoor use |
||||||||
|
Application method(s) |
Method: Injection of a stock solution from a tank or an automated feeder Detailed description: Adjustment applicable in the territory of Germany in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012: In accordance with the list of authorised treatment substances and disinfection processes of Section 20 of the German Ordinance on the Quality of Water Intended for Human Consumption (TrinkwV), the technical rules for dosing set out in the Deutscher Verein des Gas Wasserfaches e.V. -working sheets W 229, W 296, W 623 and the minimum contact time of W 229 apply (See section 6 for further references). In addition, the requirements of DIN EN 900 Tab. 1, Type 1 shall be met regarding the purity of the releaser calcium hypochlorite. |
||||||||
|
Application rate(s) and frequency |
Application rate: Primary disinfection: 3-5 mg/l (residual) Number and timing of application: Primary disinfection: Apply the product as to reach a concentration between 3 and 5 mg/l of available chlorine in water. Adjustment applicable in the territory of Germany in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012: In accordance with the list of authorised treatment substances and disinfection processes of Section 20 of the German Ordinance on the Quality of Water Intended for Human Consumption (TrinkwV). See Section 6 for further reference. Application rate: Maximum addition 1,2mg/l available chlorine in water. Concentration range after completion of treatment: max 0,3 mg/l available chlorine in water, min 0,1 mg/l available chlorine in water (including the amounts before treatment and from other treatments). In exceptional cases an addition of up to 4,7 mg/l available chlorine in water and concentration up to 0,6 mg/l available chlorine in water after treatment is acceptable if disinfection cannot be ensured by other means or if disinfection is temporarily impaired by the presence of ammonium. |
||||||||
|
Category(ies) of users |
professional |
||||||||
|
Pack sizes and packaging material |
|
4.4.1. Use-specific instructions
|
— |
Ensure that the concentration of chlorine in drinking water does not exceed national chlorine limit before consumption. |
|
— |
Ensure that the concentration of chlorate present in drinking water does not exceed the parametric values set in Directive 2020/2184. |
|
— |
For food commodities, make sure that the concentration of chlorate present in food does not exceed the maximum residue levels set in Annex III of Regulation (EC) No 396/2005. |
4.4.2. Use-specific risk mitigation measures
See general direction for use.
4.4.3. 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 direction for use.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction for use.
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general direction for use.
4.5. Use description
Table 5
use # 1-5 PT 5 – Disinfection of drinking water for human consumption in public distribution systems and portable devices (automated feeder) – industrial user
|
Product type |
PT05: Drinking water |
||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||
|
Field(s) of use |
indoor use |
||
|
Application method(s) |
Method: Application by an automated feeder Detailed description: Adjustment applicable in the territory of Germany in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012: In accordance with the list of authorised treatment substances and disinfection processes of Section 20 of the German Ordinance on the Quality of Water Intended for Human Consumption (TrinkwV), the technical rules for dosing set out in the Deutscher Verein des Gas Wasserfaches e.V. -working sheets W 229, W 296, W 623 and the minimum contact time of W 229 apply (See section 6 for further references). In addition, the requirements of DIN EN 900 Tab. 1, Type 1 shall be met regarding the purity of the releaser calcium hypochlorite. |
||
|
Application rate(s) and frequency |
Application rate: Primary disinfection: 3-5 mg/l (residual) Number and timing of application: Primary disinfection: Apply the product as to reach a concentration between 3 and 5 mg/l of available chlorine in water. Adjustment applicable in the territory of Germany in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012: In accordance with the list of authorised treatment substances and disinfection processes of Section 20 of the German Ordinance on the Quality of Water Intended for Human Consumption (TrinkwV) Application rate: Maximum addition 1,2mg/l available chlorine in water. Concentration range after completion of treatment: max 0,3 mg/l, min 0,1 mg/l available chlorine in water (including the amounts before treatment and from other treatments) In exceptional cases an addition of up to 4,7 mg/l available chlorine in water and concentration up to 0,6 mg/l available chlorine in water after treatment is acceptable, if disinfection cannot be ensured by other means or if disinfection is temporarily impaired by the presence of ammonium. |
||
|
Category(ies) of users |
industrial |
||
|
Pack sizes and packaging material |
|
4.5.1. Use-specific instructions
|
— |
Ensure that the concentration of chlorine in drinking water does not exceed national chlorine limit before consumption. |
|
— |
Ensure that the concentration of chlorate in the drinking water does not exceed the parametric values set in Directive 2020/2184.- |
|
— |
For food commodities, make sure that the concentration of chlorate present in food does not exceed the maximum residue levels set in Annex III of Regulation (EC) No 396/2005. |
4.5.2. Use-specific risk mitigation measures
See general direction for use.
4.5.3. 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 direction for use.
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction for use.
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general direction for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use
Meta-SPC 1-3:
If the concentrated chlorinated solution is prepared manually, the following procedure is to be strictly followed:
|
1. |
Always use a container perfectly cleaned-off and exclusively dedicated to this purpose. |
|
2. |
Determine the respective amounts of water and product that are necessary to be used in order to reach the desired chlorine concentration, e.g. as follows:
|
|
3. |
First, pour the necessary amount of water. |
|
4. |
While shaking gently, afterwards, slowly pour the necessary amount of product. |
|
5. |
Keep on shaking for at least 15 minutes until total dissolution of the product. |
|
— |
Always read the label or leaflet before use and follow all the instructions provided. |
|
— |
Respect the conditions of use of the product. |
|
— |
Inform the registration holder if the treatment is ineffective. |
5.2. Risk mitigation measures
Professional use:
|
— |
Wear protective coverall (type 5) in accordance with EN 13982-1 or equivalent and closed footwear in accordance with EN 13832-3 or equivalent, gloves in accordance with EN ISO 374 or equivalent (glove material to be specified by the authorisation holder within the product information) and chemical goggles in accordance with EN 166 or equivalent during mixing and loading task and post-application task (contact with solid). |
|
— |
Wear protection coverall in accordance with EN 13034 or equivalent, face shield in accordance with EN 166 or equivalent, gloves in accordance with EN ISO 374 or equivalent (glove material to be specified by the authorisation holder within the product information) and chemical goggles in accordance with EN 166 or equivalent during post-application task (contact with concentrated stock solution). |
|
— |
Wear of respiratory protective equipment (RPE) consistent with EN 136 and EN 14387 or equivalent and with an assigned protection factor of minimum (APF) 20 during manipulation of the product for the mixing and loading task with large amount of product. |
|
— |
No personal protective equipment (PPE) is needed for mixing and loading task (small scale – packaging ≤10kg) with a tool (scoop or similar). This tool must have a handle and must not be in contact to the product (must not be stored inside the packaging). Decanting has to be avoided. |
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
|
— |
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. |
|
— |
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/ambulance for medical assistance. Information to Healthcare personnel/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 INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. |
|
— |
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. |
|
— |
Keep the container or label available. |
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. |
|
— |
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
|
— |
Store below 35 °C. |
|
— |
Store away from light. |
|
— |
Store in a dry place. |
|
— |
Shelf life: 12 months. |
6. OTHER INFORMATION
With respect to the ‘Category (ies) of users’ note: ‘Professionals’ (including industrial users) means trained professionals if this is required by national legislation.
Please note that some Member states after primary disinfection, request to maintain a residual level of available chlorine in drinking water in the pipes as a precautionary measure. This additional amount, claimed by the authorisation holder as ‘Secondary disinfection: 0,2-0,5 mg/l available chlorine (residual)’ has been considered as covered by the primary disinfection.
References to national provisions for the adjustment applicable in the territory of Germany according to Article 44(5), second subparagraph, of Regulation (EU) No 528/2012:
German Ordinance on the Quality of Water Intended for Human Consumption – Verordnung über die Qualität von Wasser für den menschlichen Gebrauch (Trinkwasserverordnung – TrinkwV) in the version of the Second Ordinance for the Revision of the Drinking water Ordinance (Zweite Verordnung zur Novellierung der Trinkwasserverordnung vom 20. Juni 2023 (Bundesgesetzblatt I Nr. 159), https://www.gesetze-im-internet.de/englisch_trinkwv/englisch_trinkwv.pdf.
List of authorised treatment substances and disinfection processes of Section 20 of the TrinkwV: Bekanntmachung des Umweltbundesamtes der Liste zulässiger Aufbereitungsstoffe und Desinfektionsverfahren nach § 20 der Trinkwasserverordnung (Stand: Januar 2023) vom 13. Januar 2023, BAnz AT 27.01.2023 B12.
Deutscher Verein des Gas- und Wasserfaches e.V. (German Technical and Scientific Association for Gas and Water).
Part II, Lfd. Nr.7 of the list of authorised treatment substances and disinfection processes of paragraph 20 of the TrinkwV.
Part I c, Lfd. Nr.1 of the list of authorised treatment substances and disinfection processes of paragraph 20 of the TrinkwV.
Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast)
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. Consolidated version available at: ELI: http://data.europa.eu/eli/reg/2005/396/2024-05-11
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
DIN EN 900: Chemicals used for treatment of water intended for human consumption - Calcium hypochlorite
EN 13982-1: Protective clothing for use against solid particulates – Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates (type 5 clothing)
EN 13832-3: Footwear protecting against chemicals – Part 3: Requirements for prolonged contact with chemicals
EN ISO 374: Protective gloves against dangerous chemicals and micro-organisms
EN 166: Personal eye-protection – Specifications
EN 136: Respiratory protective devices – Full face masks – Requirements, testing, marking
EN 14387: Respiratory protective devices – Gas filter(s) and combined filter(s) – Requirements, testing, marking
EN 13034: Protective clothing against liquid chemicals – Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment).
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) |
hth Shock |
Market area: EU |
|||||
|
hth SPA CHLORSCHOCK |
Market area: EU |
||||||
|
Constant Chlor Plus CCP-S |
Market area: EU |
||||||
|
hth SPA FLASH SANITIZER |
Market area: EU |
||||||
|
Saniklar Shock |
Market area: EU |
||||||
|
hth SPA FLASH DÉSINFECTION |
Market area: EU |
||||||
|
hth Chlor Schock Pulver |
Market area: EU |
||||||
|
hth SPA SZOKOWY |
Market area: EU |
||||||
|
hth Szokowy |
Market area: EU |
||||||
|
hth SPA CHLORSCHOCK |
Market area: EU |
||||||
|
Fi-Clor SUPERFAST GRANULES |
Market area: EU |
||||||
|
Fi-Clor SUPERFAST SUPERCHLORINATOR |
Market area: EU |
||||||
|
Champion Rapid Ultrashock Granules |
Market area: EU |
||||||
|
SPLASH! Power-Chlor |
Market area: EU |
||||||
|
Calcium Hypochlorite Rapid Dissolving |
Market area: EU |
||||||
|
Calcium Hypochlorite Shock |
Market area: EU |
||||||
|
hth SPA FLASH DESINFECCIÓN |
Market area: EU |
||||||
|
SHOCK |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0001 1-1 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
65 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
100 % (w/w) |
||
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
|
Identifier |
Meta SPC: meta-SPC 2 (Water soluble granules) |
1.2. Suffix to the authorisation number
|
Number |
1-2 |
1.3. Product type(s)
|
Product type(s) |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT05: Drinking water |
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 (%) |
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
64,3 - 65 % (w/w) |
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
99 - 100 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 2
|
Formulation type(s) |
SG Water soluble granule |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
|
Hazard statements |
H272: May intensify fire; oxidiser. H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H400: Very toxic to aquatic life. EUH031: Contact with acids liberates toxic gas. EUH206: Warning! Do not use together with other products. May release dangerous gases (chlorine). EUH071: Corrosive to the respiratory tract. |
|
Precautionary statements |
P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P260: Do not breathe dust. P260: Do not breathe fume. P260: Do not breathe gas. P260: Do not breathe mist. P260: Do not breathe vapours. P260: Do not breathe spray. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a Poison Center or a doctor. P363: Wash contaminated clothing before reuse. P370+P378: In case of fire: Use water spray to extinguish. P391: Collect spillage. P501: Dispose of container in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
use # 2-1 PT 2 – Disinfection of swimming pools and spas – professional
|
Product type |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
||||||||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria (including L. pneumophila) Common name: Bacteria (including L. pneumophila) Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||||||||
|
Field(s) of use |
indoor use outdoor use |
||||||||
|
Application method(s) |
Method: Direct addition of the product or injection of a stock solution from a tank or from an automated feeder connected to the swimming pool or spa. Detailed description: |
||||||||
|
Application rate(s) and frequency |
Application rate: Maintenance: 1-3 mg/l of available chlorine in water (swimming pool), 2,5 to 4 mg/l of available chlorine in water (spas); Shock: 10 mg/l of available chlorine in water Number and timing of application: Maintenance of swimming pools: Apply the product as needed to maintain a concentration between 1 and 3 mg/l of available chlorine in water. Maintenance of spas: Apply the product as needed to maintain a concentration between 2,5 up to 4 mg/l of available chlorine in water. Shock treatment of swimming pools and spa: Apply the product as to reach a concentration of 10 mg/l of available chlorine in water (contact time: 10 minutes). |
||||||||
|
Category(ies) of users |
professional |
||||||||
|
Pack sizes and packaging material |
|
4.1.1. Use-specific instructions
|
— |
Check regularly chlorine content in the pools as UV could partially degrade chlorine. |
|
— |
Ensure complete mixing of the product to water. |
4.1.2. Use-specific risk mitigation measures
|
— |
Application of this product is exclusively allowed in swimming pools with connection to a sewage treatment plant. It is not allowed to directly discharge swimming pool water to the surface water. |
|
— |
Treatment must be made in absence of bathers for shock treatment and until complete dissolution of the product for direct application for maintenance treatment. |
|
— |
Do not allow entrance to the pool until the concentration decreases back to 3 mg/l of available chlorine for swimming pools water and 4 mg/l of available chlorine for spas water or to national chlorine limit. |
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 direction for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction 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 direction for use.
4.2. Use description
Table 2
use # 2-2 PT 2 – Disinfection of swimming pools and spas – non-professional
|
Product type |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
||||||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria (including L. pneumophila) Common name: Bacteria (including L. pneumophila) Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||||||
|
Field(s) of use |
indoor use outdoor use |
||||||
|
Application method(s) |
Method: Direct addition of the product to the water surface, e.g. with a scoop or similar. Detailed description: |
||||||
|
Application rate(s) and frequency |
Application rate: Shock: 10 mg/l of available chlorine in water Number and timing of application: Shock treatment of swimming pools and spas: Apply the product as to reach a concentration of 10 mg/l of available chlorine in water (contact time: 10 minutes), pH 6,32-7,82. |
||||||
|
Category(ies) of users |
general public (non-professional) |
||||||
|
Pack sizes and packaging material |
|
4.2.1. Use-specific instructions
|
— |
Read label before use. |
|
— |
Check regularly chlorine content in the pools as UV could partially degrade chlorine. |
|
— |
Ensure complete mixing of the product to water. |
4.2.2. Use-specific risk mitigation measures
|
— |
Use the dosing device, scoop or similar to transfer the product. This tool must be provided with the packaging and must not be in contact with the product (must not be stored inside the packaging). Decanting has to be avoided. |
|
— |
Treatment must be made in absence of bathers for shock treatment. |
|
— |
Do not entrance to the pool until the concentration decreases back to 3 mg/l of available chlorine for swimming pools water and 4 mg/l of available chlorine for spas water or to national chlorine limit . |
|
— |
Application of this product is exclusively allowed in swimming pools with connection to a sewage treatment plant. It is not allowed to directly discharge swimming pool water to the surface water. |
|
— |
Washing of hands after use. |
|
— |
Washing of face/ eye after accidental exposure. |
|
— |
Avoid contact with skin and eyes. |
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
|
— |
If medical advice is needed, have product container or label at hand. |
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction 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
|
— |
Keep out of reach of children. |
4.3. Use description
Table 3
use # 2-3 PT 4 – Disinfection of equipment, containers, pipework associated with drinking water for human consumption by filling/CIP with circulation – professional user
|
Product type |
PT04: Food and feed area |
||||||||||
|
Where relevant, an exact description of the authorised use |
Disinfection of interior surfaces of drinking water systems such as pipework by filling/CIP with circulation. |
||||||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: no data |
||||||||||
|
Field(s) of use |
indoor use |
||||||||||
|
Application method(s) |
Method: Filling of piping with stock solution Detailed description: |
||||||||||
|
Application rate(s) and frequency |
Application rate: 100 mg/l of available chlorine in water Number and timing of application: Dissolve 130 g of product into water per cubic meter of the piping to be chlorinated to reach 100 mg/l active chlorine in water. Contact time: 12 hours |
||||||||||
|
Category(ies) of users |
professional |
||||||||||
|
Pack sizes and packaging material |
|
4.3.1. Use-specific instructions
|
— |
Clean carefully the surfaces before application of the product. |
4.3.2. Use-specific risk mitigation measures
|
— |
Ensure that the concentration of chlorine in drinking water does not exceed national chlorine limit before consumption. |
|
— |
Ensure that the concentration of chlorate present in drinking water does not exceed the parametric values set in Directive 2020/2184. |
|
— |
For food commodities, make sure that the concentration of chlorate present in food does not exceed the maximum residue levels set in Annex III of Regulation (EC) No 396/2005. |
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 direction for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction 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 direction for use.
4.4. Use description
Table 4
use # 2-4 PT 5 – Disinfection of drinking water for human consumption in public distribution systems and portable devices – professional
Adjustment applicable in the territory of Germany in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012:
This use is not authorised in Germany.
|
Product type |
PT05: Drinking water |
||||||||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||||||||
|
Field(s) of use |
indoor use |
||||||||
|
Application method(s) |
Method: Injection of stock solution from a tank or injection from an automated feeder. Detailed description: |
||||||||
|
Application rate(s) and frequency |
Application rate: Primary disinfection: 3-5 mg/l (residual) Number and timing of application: Primary disinfection: Apply the product as to reach a concentration between 3 and 5 mg/l of available chlorine in water |
||||||||
|
Category(ies) of users |
professional |
||||||||
|
Pack sizes and packaging material |
|
4.4.1. Use-specific instructions
See general direction for use.
Not authorised for use in Germany.
4.4.2. Use-specific risk mitigation measures
|
— |
Ensure that the concentration of chlorine in drinking water does not exceed national chlorine limit before consumption. |
|
— |
Ensure that the concentration of chlorate present in drinking water does not exceed the parametric values set in Directive 2020/2184. |
|
— |
For food commodities, make sure that the concentration of chlorate present in food does not exceed the maximum residue levels set in Annex III of Regulation (EC) No 396/2005. |
4.4.3. 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 direction for use.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction for use.
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general direction for use.
4.5. Use description
Table 5
use # 2-5 PT 5 – Disinfection of drinking water for human consumption in public distribution systems and portable devices (automated feeder) – industrial user.
Adjustment applicable in the territory of Germany in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012:
This use is not authorised in Germany.
|
Product type |
PT05: Drinking water |
||
|
Where relevant, an exact description of the authorised use |
- |
||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||
|
Field(s) of use |
indoor use |
||
|
Application method(s) |
Method: Application by an automated feeder Detailed description: |
||
|
Application rate(s) and frequency |
Application rate: Primary disinfection: 3-5 mg/l (residual) Number and timing of application: Primary disinfection: Apply the product as to reach a concentration between 3 and 5 mg/l of available chlorine in water |
||
|
Category(ies) of users |
industrial |
||
|
Pack sizes and packaging material |
|
4.5.1. Use-specific instructions
See general direction for use.
Not authorised for use in Germany .
4.5.2. Use-specific risk mitigation measures
|
— |
Ensure that the concentration of chlorine in drinking water does not exceed national chlorine limit before consumption. |
|
— |
Ensure that the concentration of chlorate present in drinking water does not exceed the parametric values set in Directive 2020/2184. |
|
— |
For food commodities, make sure that the concentration of chlorate present in food does not exceed the maximum residue levels set in Annex III of Regulation (EC) No 396/2005. |
4.5.3. 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 direction for use.
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction for use.
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general direction for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use
Meta-SPC 1-3:
If the concentrated chlorinated solution is prepared manually, the following procedure is to be strictly followed:
|
1. |
Always use a container perfectly cleaned-off and exclusively dedicated to this purpose. |
|
2. |
Determine the respective amounts of water and product that are necessary to be used in order to reach the desired chlorine concentration, e.g. as follows:
|
|
3. |
First, pour the necessary amount of water. |
|
4. |
While shaking gently, afterwards, slowly pour the necessary amount of product. |
|
5. |
Keep on shaking for at least 15 minutes until total dissolution of the product. |
|
— |
Always read the label or leaflet before use and follow all the instructions provided. |
|
— |
Respect the conditions of use of the product. |
|
— |
Inform the registration holder if the treatment is ineffective. |
5.2. Risk mitigation measures
Professional use:
|
— |
Wear protective coverall (type 5) in accordance with EN 13982-1 or equivalent and closed footwear in accordance with EN 13832-3 or equivalent, gloves in accordance with EN ISO 374 or equivalent (glove material to be specified by the authorisation holder within the product information) and chemical goggles in accordance with EN 166 or equivalent during mixing and loading task and post-application task (contact with solid). |
|
— |
Wear protection coverall in accordance with EN 13034 or equivalent, face shield in accordance with EN 166 or equivalent, gloves in accordance with EN ISO 374 or equivalent (glove material to be specified by the authorisation holder within the product information) and chemical goggles in accordance with EN 166 or equivalent during post-application task (contact with concentrated stock solution). |
|
— |
Wear of respiratory protective equipment (RPE) consistent with EN 136 and EN 14387 or equivalent and with an assigned protection factor of minimum (APF) 20 during manipulation of the product for the mixing and loading task with large amount of product. |
|
— |
No personal protective equipment (PPE) is needed for mixing and loading task (small scale – packaging ≤10kg) with a tool (scoop or similar). This tool must have a handle and must not be in contact to the product (must not be stored inside the packaging). Decanting has to be avoided. |
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
|
— |
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. |
|
— |
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/ambulance for medical assistance. Information to Healthcare personnel/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 INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. |
|
— |
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. |
|
— |
Keep the container or label available. |
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. |
|
— |
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
|
— |
Store below 35 °C. |
|
— |
Store away from light. |
|
— |
Store in a dry place. |
|
— |
Shelf life: 12 months. |
6. OTHER INFORMATION
With respect to the ‘Category (ies) of users’ note: ‘Professionals’ (including industrial users) means trained professionals if this is required by national legislation.
Please note that some Member states after primary disinfection, request to maintain a residual level of available chlorine in drinking water in the pipes as a precautionary measure. This additional amount, claimed by the authorisation holder as ‘Secondary disinfection: 0,2-0,5 mg/l available chlorine (residual)’ has been considered as covered by the primary disinfection.
References to national provisions for the adjustment applicable in the territory of Germany according to Article 44(5), second subparagraph, of Regulation (EU) No 528/2012:
German Ordinance on the Quality of Water Intended for Human Consumption – Verordnung über die Qualität von Wasser für den menschlichen Gebrauch (Trinkwasserverordnung – TrinkwV) in the version of the Second Ordinance for the Revision of the Drinking water Ordinance (Zweite Verordnung zur Novellierung der Trinkwasserverordnung vom 20. Juni 2023 (Bundesgesetzblatt I Nr. 159), https://www.gesetze-im-internet.de/englisch_trinkwv/englisch_trinkwv.pdf.
List of authorised treatment substances and disinfection processes of Section 20 of the TrinkwV: Bekanntmachung des Umweltbundesamtes der Liste zulässiger Aufbereitungsstoffe und Desinfektionsverfahren nach § 20 der Trinkwasserverordnung (Stand: Januar 2023) vom 13. Januar 2023, BAnz AT 27.01.2023 B12.
Deutscher Verein des Gas- und Wasserfaches e.V. (German Technical and Scientific Association for Gas and Water).
Part II, Lfd. Nr.7 of the list of authorised treatment substances and disinfection processes of paragraph 20 of the TrinkwV.
Part I c, Lfd. Nr.1 of the list of authorised treatment substances and disinfection processes of paragraph 20 of the TrinkwV.
Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast)
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. Consolidated version available at: ELI: http://data.europa.eu/eli/reg/2005/396/2024-05-11
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
DIN EN 900: Chemicals used for treatment of water intended for human consumption – Calcium hypochlorite
EN 13982-1: Protective clothing for use against solid particulates – Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates (type 5 clothing)
EN 13832-3: Footwear protecting against chemicals – Part 3: Requirements for prolonged contact with chemicals
EN ISO 374: Protective gloves against dangerous chemicals and micro-organisms
EN 166: Personal eye-protection – Specifications
EN 136: Respiratory protective devices – Full face masks – Requirements, testing, marking
EN 13034: Protective clothing against liquid chemicals – Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment).
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) |
hth granular |
Market area: EU |
|||||
|
BLUE TECH RAPID BLUE |
Market area: EU |
||||||
|
Constant Chlor plus CCP-G |
Market area: EU |
||||||
|
hth GRANULAR SANITIZER |
Market area: EU |
||||||
|
hth DÉSINFECTANT GRANULÉS |
Market area: EU |
||||||
|
hth DESINFECTANTE GRANULADO |
Market area: EU |
||||||
|
Marina RAPID BLUE |
Market area: EU |
||||||
|
hth Granulat |
Market area: EU |
||||||
|
Saniklar Super Boost |
Market area: EU |
||||||
|
Marina Calcium Hypochlorite Granular |
Market area: EU |
||||||
|
hth Chlorgranulat |
Market area: EU |
||||||
|
Granular Chlorine |
Market area: EU |
||||||
|
ADIC 513 |
Market area: EU |
||||||
|
Infinity Desical H70 Grano |
Market area: EU |
||||||
|
Champion Chlorine Shock Granules |
Market area: EU |
||||||
|
SPLASH! Shock Chlorine Granules |
Market area: EU |
||||||
|
CALCIUMHYPOCHLORIT GRANULIERT |
Market area: EU |
||||||
|
CALCIUMHYPOCHLORIT GRAN.(BLAU) |
Market area: EU |
||||||
|
Aqua-Net Calhypo |
Market area: EU |
||||||
|
Trichlorin K |
Market area: EU |
||||||
|
Calhypo Granulat |
Market area: EU |
||||||
|
Calciumhypochlorit Granulat |
Market area: EU |
||||||
|
BIOCOR HC |
Market area: EU |
||||||
|
BIOCOR GLP |
Market area: EU |
||||||
|
KWZ 990 ChlorGranul |
Market area: EU |
||||||
|
KWZ 992 ChlorGranul 25 |
Market area: EU |
||||||
|
Calcium Hypochlorite Granules |
Market area: EU |
||||||
|
IPOCAL-POOL SD GRANULATE |
Market area: EU |
||||||
|
Chlorom C granulat |
Market area: EU |
||||||
|
Chlor Gran 70% |
Market area: EU |
||||||
|
Hypo Chlor |
Market area: EU |
||||||
|
GranuPool 70 % |
Market area: EU |
||||||
|
Chlorex C |
Market area: EU |
||||||
|
hth GRANULAR |
Market area: EU |
||||||
|
CCH GRANULAR |
Market area: EU |
||||||
|
HYPOBLACK GRANULAR |
Market area: EU |
||||||
|
POOLSUD GRANULAR |
Market area: EU |
||||||
|
Calcium Hypochlorite Granular |
Market area: EU |
||||||
|
GRANULAR |
Market area: EU |
||||||
|
RAPID BLUE |
Market area: EU |
||||||
|
BEQ CHLOR ŠOK |
Market area: EU |
||||||
|
PWS CHLOR SHOCK granulovaný |
Market area: EU |
||||||
|
BENAQUA CHLOR ŠOK granulovaný |
Market area: EU |
||||||
|
PWS MODRÝ BLESK PLUS |
Market area: EU |
||||||
|
PWS CHLOR FOR WATER |
Market area: EU |
||||||
|
KRYSTALPOOL CHLOR ŠOK granulát |
Market area: EU |
||||||
|
CHLOR ŠOK granulát |
Market area: EU |
||||||
|
CHLOR SHOCK |
Market area: EU |
||||||
|
Chlornan vápenatý |
Market area: EU |
||||||
|
MAREVAKLORIT |
Market area: EU |
||||||
|
Chlorano HC |
Market area: EU |
||||||
|
hth chips |
Market area: EU |
||||||
|
CHIPS |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0002 1-2 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
65 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
100 % (w/w) |
||
7.2. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
hth easiflow granular |
Market area: EU |
|||||
|
hth easiflo granular |
Market area: EU |
||||||
|
POOLSUD |
Market area: EU |
||||||
|
Easiflo Granular |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0003 1-2 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
64,5 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
99,3 % (w/w) |
||
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
|
Identifier |
Meta SPC: meta-SPC 3 (Water soluble tablets) |
1.2. Suffix to the authorisation number
|
Number |
1-3 |
1.3. Product type(s)
|
Product type(s) |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT05: Drinking water |
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 (%) |
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
58,1 - 65 % (w/w) |
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
89 - 100 % (w/w) |
|
Calcium dihydroxide |
|
Non-Active substance |
1305-62-0 |
215-137-3 |
0 - 9,5 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 3
|
Formulation type(s) |
ST Water soluble tablet |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
|
Hazard statements |
H272: May intensify fire; oxidiser. H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H400: Very toxic to aquatic life. EUH031: Contact with acids liberates toxic gas. EUH206: Warning! Do not use together with other products. May release dangerous gases (chlorine). EUH071: Corrosive to the respiratory tract. |
|
Precautionary statements |
P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P260: Do not breathe dust. P260: Do not breathe fume. P260: Do not breathe gas. P260: Do not breathe mist. P260: Do not breathe vapours. P260: Do not breathe spray. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a Poison Center or a doctor. P363: Wash contaminated clothing before reuse. P370+P378: In case of fire: Use water spray to extinguish. P391: Collect spillage. P501: Dispose of container in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
use # 3-1 PT 2 – Disinfection of swimming pools and spas – professional
|
Product type |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
||||||||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria (including L. pneumophila) Common name: Bacteria (including L. pneumophila) Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||||||||
|
Field(s) of use |
indoor use outdoor use |
||||||||
|
Application method(s) |
Method: Dissolution using a floating device, Dissolution through skimmer, Injection through automated feeder connected to the swimming pool or spa Detailed description: |
||||||||
|
Application rate(s) and frequency |
Application rate: Maintenance: 1-3 mg/l of available chlorine in water (swimming pool), 2,5 to 4 mg/l of available chlorine in water (spas); Shock treatment: 10 mg/l of available chlorine in water Number and timing of application: Maintenance of swimming pools: Apply the product as needed to maintain a concentration between 1 and 3 mg/l of available chlorine in water. Maintenance of spas: Apply the product as needed to maintain a concentration between 2,5 up to 4 mg/l of available chlorine in water. Shock treatment of swimming pools and spa: Apply the product as to reach a concentration of 10 mg/l of available chlorine in water (contact time: 10 minutes). |
||||||||
|
Category(ies) of users |
professional |
||||||||
|
Pack sizes and packaging material |
|
4.1.1. Use-specific instructions
|
— |
Check regularly chlorine content in the pools as UV could partially degrade chlorine. |
|
— |
Ensure complete mixing of the product to water. |
4.1.2. Use-specific risk mitigation measures
|
— |
Treatment must be made in absence of bathers for shock treatment. |
|
— |
Do not allow entrance to the pool until the concentration decreases back to 3 mg/l of available chlorine for swimming pools water and 4 mg/l of available chlorine for spas water or to national chlorine limit. |
|
— |
Application of this product is exclusively allowed in swimming pools with connection to a sewage treatment plant. It is not allowed to directly discharge swimming pool water to the surface water. |
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 direction for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction 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 direction for use.
4.2. Use description
Table 2
use # 3-2 PT 2 – Disinfection of swimming pools and spas – non-professional
|
Product type |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
||||||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria (including L. pneumophila) Common name: Bacteria (including L. pneumophila) Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||||||
|
Field(s) of use |
indoor use outdoor use |
||||||
|
Application method(s) |
Method: Dissolution through a skimmer, Dissolution using a floating device, Injection through an automated feeder Detailed description: |
||||||
|
Application rate(s) and frequency |
Application rate: Maintenance: 1-3 mg/l of available chlorine in water (swimming pool), 2,5 to 4 mg/l of available chlorine in water (spas); Shock treatement: 10 mg/l of available chlorine in water. Contact time 10 min, pH 6,32-7,82 Number and timing of application: - |
||||||
|
Category(ies) of users |
general public (non-professional) |
||||||
|
Pack sizes and packaging material |
|
4.2.1. Use-specific instructions
|
— |
Read label before use. |
|
— |
Check regularly chlorine content in the pools as UV could partially degrade chlorine. |
|
— |
Ensure complete mixing of the product to water. |
4.2.2. Use-specific risk mitigation measures
|
— |
Use a plier or similar to transfer the product. This tool must be provided with the packaging and must not be in contact with the product (must not be stored inside the packaging). Decanting has to be avoided. |
|
— |
Application of this product is exclusively allowed in swimming pools with connection to a sewage treatment plant. It is not allowed to directly discharge swimming pool water to the surface water. |
|
— |
Do not allow entrance to the pool until the concentration decreases back to 3 mg/l of available chlorine for swimming pools water and 4 mg/l of available chlorine for spas water or to national chlorine limit. |
|
— |
Treatment must be made in absence of bathers for shock treatment. |
|
— |
Avoid contact with skin and eyes |
|
— |
Washing of hands after use. |
|
— |
Washing of face/ eye after accidental exposure. |
|
— |
Wait for the complete dissolution of the product before working on the floating device, dosing pump or the skimmer. |
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 direction for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
|
— |
If medical advice is needed, have product container or label at hand. |
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
|
— |
Keep out of reach of children. |
4.3. Use description
Table 3
use # 3-3 PT 4 – Disinfection of equipment, containers, pipework associated with drinking water for human consumption by filling/CIP with circulation– professional user
|
Product type |
PT04: Food and feed area |
||||||||||
|
Where relevant, an exact description of the authorised use |
Disinfection of interior surfaces of drinking water systems such as pipework by filling/CIP with circulation; |
||||||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: no data |
||||||||||
|
Field(s) of use |
indoor use |
||||||||||
|
Application method(s) |
Method: Filling of piping with stock solution Detailed description: |
||||||||||
|
Application rate(s) and frequency |
Application rate: 100 mg/l of available chlorine in water Number and timing of application: Dissolve 130 g of product into water per cubic meter of the piping to be chlorinated to reach 100 mg/l of available chlorine in water Contact time: 12 hours |
||||||||||
|
Category(ies) of users |
professional |
||||||||||
|
Pack sizes and packaging material |
|
4.3.1. Use-specific instructions
|
— |
Clean carefully the surfaces before application of the product. |
|
— |
Dissolve xx g [amount to be specified by authorisation holder for each individual product] of product into water per cubic meter of the piping to be chlorinated (100 mg/L active chlorine). |
4.3.2. Use-specific risk mitigation measures
|
— |
Ensure that the concentration of chlorine in drinking water does not exceed national chlorine limit before consumption. |
|
— |
Ensure that the concentration of chlorate present in drinking water does not exceed the parametric values set in Directive 2020/2184. |
|
— |
For food commodities, make sure that the concentration of chlorate present in food does not exceed the maximum residue levels set in Annex III of Regulation (EC) No 396/2005. |
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 direction for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction 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 direction for use.
4.4. Use description
Table 4
use # 3-4 PT 5 – Disinfection of drinking water for human consumption in public distribution systems and portable devices – professional
Adjustment applicable in the territory of Germany in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012:
This use is not authorised in Germany.
|
Product type |
PT05: Drinking water |
||||||||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||||||||
|
Field(s) of use |
indoor use |
||||||||
|
Application method(s) |
Method: Injection of a stock solution from a tank or from an automated feeder Detailed description: Viruses |
||||||||
|
Application rate(s) and frequency |
Application rate: Primary disinfection: 3-5 mg/l (residual) Number and timing of application: Primary disinfection: Apply the product as to reach a concentration between 3 and 5 mg/l of available chlorine in water |
||||||||
|
Category(ies) of users |
professional |
||||||||
|
Pack sizes and packaging material |
|
4.4.1. Use-specific instructions
See general direction for use.
Not authorised for use in Germany.
4.4.2. Use-specific risk mitigation measures
|
— |
Ensure that the concentration of chlorine in dinking water does not exceed national chlorine limit before consumption. |
|
— |
Ensure that the concentration of chlorate present in the drinking water does not exceed the parametric values set in Directive 2020/2184. |
|
— |
For food commodities, make sure that the concentration of chlorate present in food does not exceed the maximum residue levels in Annex III of Regulation (EC) No 396/2005. |
4.4.3. 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 direction for use.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction for use.
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general direction for use.
4.5. Use description
Table 5
use # 3-5 PT 5 – Disinfection of drinking water for human consumption in public distribution systems and portable devices (automated feeder) – industrial user
Adjustment applicable in the territory of Germany in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012:
This use is not authorised in Germany.
|
Product type |
PT05: Drinking water |
||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||
|
Field(s) of use |
indoor use |
||
|
Application method(s) |
Method: Appliation by an automated feeder Detailed description: |
||
|
Application rate(s) and frequency |
Application rate: Primary disinfection: 3-5 mg/l (residual) Number and timing of application: Primary disinfection: Apply the product as to reach a concentration between 3 and 5 mg/l of available chlorine in water |
||
|
Category(ies) of users |
industrial |
||
|
Pack sizes and packaging material |
|
4.5.1. Use-specific instructions
See general direction for use.
Not authorised for use in Germany.
4.5.2. Use-specific risk mitigation measures
|
— |
Ensure that the concentration of chlorine in drinking water does not exceed national chlorine limit before consumption. |
|
— |
Ensure that the concentration of chlorate present in drinking water does not exceed the parametric values set in Directive 2020/2184. |
|
— |
For food commodities, make sure that the concentration of chlorate present in food does not exceed the maximum residue levels set in Annex III of Regulation (EC) No 396/2005. |
4.5.3. 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 direction for use
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction for use
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general direction for use
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1. Instructions for use
Meta-SPC 1-3:
If the concentrated chlorinated solution is prepared manually, the following procedure is to be strictly followed:
|
1. |
Always use a container perfectly cleaned-off and exclusively dedicated to this purpose. |
|
2. |
Determine the respective amounts of water and product that are necessary to be used in order to reach the desired chlorine concentration, e.g. as follows:
|
|
3. |
First, pour the necessary amount of water. |
|
4. |
While shaking gently, afterwards, slowly pour the necessary amount of product. |
|
5. |
Keep on shaking for at least 15 minutes until total dissolution of the product. |
|
— |
Always read the label or leaflet before use and follow all the instructions provided. |
|
— |
Respect the conditions of use of the product. |
|
— |
Inform the registration holder if the treatment is ineffective. |
5.2. Risk mitigation measures
Professional use:
|
— |
Wear protective coverall (type 5) in accordance with EN 13982-1 or equivalent and closed footwear in accordance with EN 13832-3 or equivalent, gloves in accordance with EN ISO 374 or equivalent (glove material to be specified by the authorisation holder within the product information) and chemical goggles in accordance with EN 166 or equivalent during mixing and loading task and post-application task (contact with solid). |
|
— |
Wear protection coverall in accordance with EN 13034 or equivalent, face shield in accordance with EN 166 or equivalent, gloves in accordance with EN ISO 374 or equivalent (glove material to be specified by the authorisation holder within the product information) and chemical goggles in accordance with EN 166 or equivalent during post-application task (contact with concentrated stock solution). |
|
— |
Wear of respiratory protective equipment (RPE) consistent with EN 136 and EN 14387 or equivalent and with an assigned protection factor of minimum (APF) 20 during manipulation of the product for the mixing and loading task with large amount of product. |
|
— |
No personal protective equipment (PPE) is needed for mixing and loading task (small scale – packaging ≤10kg) with a tool (scoop or similar). This tool must have a handle and must not be in contact to the product (must not be stored inside the packaging). Decanting has to be avoided. |
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
|
— |
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. |
|
— |
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/ambulance for medical assistance. Information to Healthcare personnel/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 INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. |
|
— |
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. |
|
— |
Keep the container or label available. |
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. |
|
— |
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
|
— |
Store below 30 °C. |
|
— |
Store away from light. |
|
— |
Store in a dry place. |
|
— |
Shelf life: 12 months. |
6. OTHER INFORMATION
With respect to the ‘Category (ies) of users’ note: ‘Professionals’ (including industrial users) means trained professionals if this is required by national legislation.
Please note that some Member states after primary disinfection, request to maintain a residual level of available chlorine in drinking water in the pipes as a precautionary measure. This additional amount, claimed by the authorisation holder as ‘Secondary disinfection: 0,2-0,5 mg/l available chlorine (residual)’ has been considered as covered by the primary disinfection.
References to national provisions for the adjustment applicable in the territory of Germany according to Article 44(5), second subparagraph, of Regulation (EU) No 528/2012:
German Ordinance on the Quality of Water Intended for Human Consumption – Verordnung über die Qualität von Wasser für den menschlichen Gebrauch (Trinkwasserverordnung – TrinkwV) in the version of the Second Ordinance for the Revision of the Drinking water Ordinance (Zweite Verordnung zur Novellierung der Trinkwasserverordnung vom 20. Juni 2023 (Bundesgesetzblatt I Nr. 159), https://www.gesetze-im-internet.de/englisch_trinkwv/englisch_trinkwv.pdf.
List of authorised treatment substances and disinfection processes of Section 20 of the TrinkwV: Bekanntmachung des Umweltbundesamtes der Liste zulässiger Aufbereitungsstoffe und Desinfektionsverfahren nach § 20 der Trinkwasserverordnung (Stand: Januar 2023) vom 13. Januar 2023, BAnz AT 27.01.2023 B12.
Deutscher Verein des Gas- und Wasserfaches e.V. (German Technical and Scientific Association for Gas and Water).
Part II, Lfd. Nr.7 of the list of authorised treatment substances and disinfection processes of paragraph 20 of the TrinkwV.
Part I c, Lfd. Nr.1 of the list of authorised treatment substances and disinfection processes of paragraph 20 of the TrinkwV.
Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast)
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. Consolidated version available at: ELI: http://data.europa.eu/eli/reg/2005/396/2024-05-11
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
DIN EN 900: Chemicals used for treatment of water intended for human consumption – Calcium hypochlorite
EN 13982-1: Protective clothing for use against solid particulates – Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates (type 5 clothing)
EN 13832-3: Footwear protecting against chemicals – Part 3: Requirements for prolonged contact with chemicals
EN ISO 374: Protective gloves against dangerous chemicals and micro-organisms
EN 166: Personal eye-protection – Specifications
EN 136: Respiratory protective devices – Full face masks – Requirements, testing, marking
EN 13034: Protective clothing against liquid chemicals – Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment).
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) |
CCH tablets |
Market area: EU |
|||||
|
TABLETS |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0004 1-3 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
64,3 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
99 % (w/w) |
||
7.2. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
hth Briquette |
Market area: EU |
|||||
|
Saniklar Day Tabs |
Market area: EU |
||||||
|
Marina CHLOR EKONOMICZNY |
Market area: EU |
||||||
|
Pulsar Plus Briquettes |
Market area: EU |
||||||
|
BRIQUETTE |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0005 1-3 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
65 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
100 % (w/w) |
||
7.3. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
Hth Duration unwrapped |
Market area: EU |
|||||
|
Hth Duration |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0006 1-3 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
64 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
98,5 % (w/w) |
||
|
Calcium dihydroxide |
|
Non-Active substance |
1305-62-0 |
215-137-3 |
1,5 % (w/w) |
||
7.4. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
hth Stick |
Market area: EU |
|||||
|
Constant Chlor Plus CCP-STICK |
Market area: EU |
||||||
|
FI-CLOR Supercapsules |
Market area: EU |
||||||
|
Saniklar Tempo STICK |
Market area: EU |
||||||
|
STICK |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0007 1-3 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
64 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
98,5 % (w/w) |
||
|
Calcium dihydroxide |
|
Non-Active substance |
1305-62-0 |
215-137-3 |
1,5 % (w/w) |
||
7.5. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
hth e-flo briquette |
Market area: EU |
|||||
|
Constant Chlor Plus CCP-B7 |
Market area: EU |
||||||
|
Constant Chlor Plus Briquette |
Market area: EU |
||||||
|
ChlorTek 101 |
Market area: EU |
||||||
|
MICROCHEM M101 |
Market area: EU |
||||||
|
HEL 6063 |
Market area: EU |
||||||
|
accepta 6063 |
Market area: EU |
||||||
|
Calcium Hypochlorite Briquettes |
Market area: EU |
||||||
|
hth easiflo briquette |
Market area: EU |
||||||
|
Easiflo briquette |
Market area: EU |
||||||
|
hth Easiflo Pastylki |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0008 1-3 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
64,5 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
99,3 % (w/w) |
||
7.6. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
Poolife A300 |
Market area: EU |
|||||
|
hth POOLIFE Autofeed A 300 |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0009 1-3 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
64,3 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
98,9 % (w/w) |
||
7.7. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
CCH Endurance |
Market area: EU |
|||||
|
Constant Chlor Plus Marathon |
Market area: EU |
||||||
|
ENDURANCE |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0010 1-3 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
58,4 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
89,9 % (w/w) |
||
|
Calcium dihydroxide |
|
Non-Active substance |
1305-62-0 |
215-137-3 |
9 % (w/w) |
||
7.8. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
hth Advanced |
Market area: EU |
|||||
|
FI-CLOR Advanced |
Market area: EU |
||||||
|
Saniklar Advanced |
Market area: EU |
||||||
|
Advanced |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0011 1-3 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
58,8 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
90,5 % (w/w) |
||
|
Calcium dihydroxide |
|
Non-Active substance |
1305-62-0 |
215-137-3 |
9,4 % (w/w) |
||
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
|
Identifier |
Meta SPC: meta-SPC 4 (Water soluble tablets - Non-oxidising) |
1.2. Suffix to the authorisation number
|
Number |
1-4 |
1.3. Product type(s)
|
Product type(s) |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
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 (%) |
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
40,3 - 40,3 % (w/w) |
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
62 - 62 % (w/w) |
|
Calcium dihydroxide |
|
Non-Active substance |
1305-62-0 |
215-137-3 |
10,5 - 11 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 4
|
Formulation type(s) |
ST Water soluble tablet |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
|
Hazard statements |
H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H400: Very toxic to aquatic life. H272: May intensify fire; oxidiser. EUH031: Contact with acids liberates toxic gas. EUH071: Corrosive to the respiratory tract. EUH206: Warning! Do not use together with other products. May release dangerous gases (chlorine). |
|
Precautionary statements |
P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P260: Do not breathe dust. P260: Do not breathe fume. P260: Do not breathe gas. P260: Do not breathe mist. P260: Do not breathe vapours. P260: Do not breathe spray. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a Poison Center or a doctor. P363: Wash contaminated clothing before reuse. P391: Collect spillage. P501: Dispose of container in accordance with local regulations. P370+P378: In case of fire: Use water spray to extinguish. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
use # 4-1 PT 2 – Disinfection of swimming pools and spas – non-professional
|
Product type |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
||||||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria (including L. pneumophila) Common name: Bacteria (including L. pneumophila) Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data |
||||||
|
Field(s) of use |
indoor use outdoor use |
||||||
|
Application method(s) |
Method: Dissolution through skimmer Detailed description: |
||||||
|
Application rate(s) and frequency |
Application rate: Maintenance: 1-3 mg/l of available chlorine in water (swimming pool), 2,5 to 4 mg/l of available chlorine in water (spas) Number and timing of application: Maintenance of swimming pools: Apply the product as needed to maintain a concentration between 1 and 3 mg/l of available chlorine in water (pH 6,32-7,82) Maintenance of spas: Apply the product as needed to maintain a concentration between 2,5 up to 4 mg/l of available chlorine in water (pH 6,32-7,82). \ |
||||||
|
Category(ies) of users |
general public (non-professional) |
||||||
|
Pack sizes and packaging material |
|
4.1.1. Use-specific instructions
|
— |
Check regularly chlorine content in the pools as UV could partially degrade chlorine. |
|
— |
Ensure complete mixing of the product to water. |
4.1.2. Use-specific risk mitigation measures
See general direction 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 direction for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general direction 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 direction for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
5.1. Instructions for use
|
— |
Read label before use |
|
— |
Always read the label or leaflet before use and follow all the instructions provided. |
|
— |
Respect the conditions of use of the product. |
|
— |
Inform the registration holder if the treatment is ineffective. |
5.2. Risk mitigation measures
|
— |
Use a plier or similar to transfer the product. This tool must be provided with the packaging and must not be in contact with the product (must not be stored inside the packaging). Decanting has to be avoided. |
|
— |
Avoid contact with skin and eyes |
|
— |
Washing of hands after use |
|
— |
Washing of face/ eye after accidental exposure |
|
— |
Wait for the complete dissolution of the product before working on the floating device, dosing pump or the skimmer. |
|
— |
Application of this product is exclusively allowed in swimming pools with connection to a sewage treatment plant. It is not allowed to directly discharge swimming pool water to the surface water. |
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 ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. |
|
— |
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/ambulance for medical assistance. Information to Healthcare personnel/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 INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. |
|
— |
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. |
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. |
|
— |
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
|
— |
Store below 30 °C. |
|
— |
Store away from light. |
|
— |
Store in a dry place. |
|
— |
Shelf life: 12 months. |
|
— |
Keep out of reach of children. |
6. OTHER INFORMATION
-
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) |
hth Blue Sparkle |
Market area: EU |
|||||
|
Marina Long Blue |
Market area: EU |
||||||
|
Blue tech long blue |
Market area: EU |
||||||
|
Long Blue |
Market area: EU |
||||||
|
Authorisation number |
|
EU-0027464-0012 1-4 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Active chlorine released from calcium hypochlorite |
|
active substance |
|
|
40,3 % (w/w) |
||
|
Calcium hypochlorite |
|
releaser |
7778-54-3 |
231-908-7 |
62 % (w/w) |
||
|
Calcium dihydroxide |
|
Non-Active substance |
1305-62-0 |
215-137-3 |
10,9 % (w/w) |
||
ELI: http://data.europa.eu/eli/reg_impl/2025/831/oj
ISSN 1977-0677 (electronic edition)