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A.I.S.E. input to the Technical Hamonisation WP 24 April.doc

Detergents Regulation
A.I.S.E input to the Technical Harmonisation WP meeting on 24 April

• Biodegradability
The detergents industry supports the Commission’s new proposal, which suggests assessing the need to set out new biodegradability criteria, as described here under:
For the purpose of point (b), the Commission shall assess the need to set out biodegradability criteria for:
• Film polymers by [3 years from the entry into force of this Regulation] and
• Other intentionally added organic substances in concentration of at least 10% in detergents, by [5 years from entry into force of this Regulation].

The industry welcomes such proposal as we share Commission’s concerns also highlighted by the Presidency’s communication that test methods need to be adjusted and developed to assess biodegradability for film polymers. Furthermore, regarding organic substances, there has been no impact assessment and no scientific analysis to determine which substances are being considered in the scope. There is a need to better identify the associated risks, and significant knowledge gaps remain.
A proper impact assessment should be undertaken before considering implementing new biodegradability requirements that will affect the majority of the product composition, as we expect these provisions to have a major impact on detergents performance. An analysis should be performed to assess the benefits or this measure vs. the potential adverse effects created by it, especially while considering the potential reduction of product efficiency or sustainability aspects. The proposal from the Commission will allow for such assessment to be performed.
Definitions:
Our industry supports the new definition proposed on film polymers:
(12a) ‘Film polymers’ means polymers used in water-soluble films to encapsulate detergents;
Such definition brings certainty about the range of substances that would be considered for new biodegradability criteria, meaning the polymers present in water-soluble films used in detergents capsules.
• Ingredients data sheet transfer
The industry supports the Commission’s latest proposal, which proposes to investigate how the transfer of the ingredients datasheet (IDS) for non-hazardous detergents could be facilitated in the future:
Article 26 – add a new para 6c
The Commission is empowered to adopt delegated acts in accordance with Article 27 amending Annexes IV by setting our requirements on the way the ingredients data sheet is to be communicated in accordance with Article 7(6). When developing these requirements, the Commission shall take into account the need to ensure effective access to the ingredients data sheet to appointed bodies referred to in Article 45 of Regulation (EC) No 1272/2008, as well as the need to limit the administrative burden.
The question regarding the best way to transfer an IDS for non-hazardous detergents is a complex one, which needs to be properly investigated, both in terms of practical implications for implementation but also for the potential repercussions for the industry. We recommend that such investigation needs to be conducted based on a proper analysis and, in the meantime, not to impose the transfer of the IDS through the DPP as it would lead to further administrative burden for the industry and lead to confusion in case of medical response as they would first need to establish where to find the right information (ECHA portal for classified detergents vs DPP for non-classified detergents).
• Microorganisms
The industry fully supports the direction the Commission is taking with the draft compromise currently under consideration, which is aligning with the Council’s mandate proposing the risk assessment for the use of microorganisms in cleaning products.

However, we would like to highlight for your attention a few points from the Commission’s proposal which we believe would need to be further assessed. To this end, we would appreciate if could take into consideration the following recommendations:
• Provisions on pathogenic microorganisms - Annex II, part 2 - Line 428
Commission’s new proposal amends the texts as follows: “The following pathogenic micro-organisms shall not be present in detergents containing micro-organisms”.
Industry’s recommendation is to keep the text as proposed by the Commission when the revision was first published (in 2023): The following pathogenic micro-organisms shall not be present in any of the strains included in the finished product
The newly proposed wording indeed imposes to test for pathogenicity the final microbial cleaner product rather than the strains of microorganisms that are intentionally added to the microbial cleaner. We share these concerns because:
◦ Testing the final product will be more technically challenging and will require lengthy external testing, which might delay the placing on the market for such products.
◦ Imposing such product testing will generate higher costs for the manufacturer, as the manufacturer will need to cover the costs for the regular testing that will be required (e.g. for every batch that might be produced).
◦ Instead, it can be demonstrated that no pathogenic microorganisms are used through testing the strains that are intentionally added. Such testing is already performed by the suppliers of microorganisms and does not add extra burden on the manufacturers, while making sure that safe microorganisms are added to the product.
• Claims substantiation (line 440, in relation with lines 442-444)
Commission’s draft proposal circulated with Members States on 16 April proposes the following:
The manufacturer shall substantiate all claims regarding the actions or performance of the micro-organisms intentionally added to the product with appropriate tests.
Our industry welcomes the deletion of the “third-party testing” requirement from the text, as it gives the opportunity for manufacturers to substantiate the claims also internally.
However, we would also like to point out that this paragraph overlaps, to some extent at least, with the scope of the Unfair Commercial Practices Directive (UCPD) and the Misleading and Comparative Advertisement Directive, which already impose that claims cannot mislead the consumer and that such claims should be substantiated by adequate and verifiable evidence. However, these legislations don’t impose that this evidence / these tests need to be executed in a GLP (Good Laboratory Practices) compliant or accredited laboratory.
As [Annex II – point 9] is referred to in [Annex II – point 11] of the Detergents Regulation revision proposal, this is therefore adding an extra requirement for microbial cleaners, when compared to UCPD or the Misleading and Comparative Advertisement Directive. This also means that the laboratory generating the claim support will have different requirements if a detergent contains microorganisms or not.
Based on the above, we recommend deleting point 9 all together from the text (as it overlaps with UCPD and creates a specific additional requirement for detergents containing microorganisms) or, if not possible, at least delete point 9 from the text of point 11:
11. The tests referred to in points 1, 2, 4, 5, 6, 7 and 9 shall be conducted by laboratories meeting any of the following conditions:

• GMOs – Annex II, part 8a (new)
◦ The use of genetically modified organism (GMOs) is regulated under Directive 2001/18/EC.
◦ Should the use of GMOs be allowed in microbial cleaners, genetically modified (micro)organisms should also follow the provisions of Directive 2001/18/EC.
◦ However, while some microbial cleaners might contain GMOs, some others might use regular microorganisms that won’t have been genetically modified.
◦ We therefore recommend modifying the text of Annex II - part 8a to the following proposal:
8a. Detergents containing micro-organisms shall be placed on the market only if the safe use for the human health and the environment is demonstrated based on a risk assessment performed in accordance with the methodology to be established by the Commission based on Article 26 (…) or and, if applicable, in accordance with Directive 2001/18/EC.
• Dosing
A.I.S.E. would like to bring to Member States attention the following points on colour and contrast markings for dosing devices and measuring cups which are still under discussion.
We call on Member States to oppose the EP mandate for Annex V, point 7c & point 7ca | Lines 514 & 514a.
The introduction of mandatory dosage markings in bottle closures (such as proposed in line 514a of the European Parliament) is counterproductive and goes against the stated goal of the industry as well as regulators to reduce packaging waste, increase recycling and include recycled content.
The proposals made by the Parliament would have severe sustainability and administrative consequences:
• Efforts to reduce packaging waste, e.g., by using flat caps, will be made more difficult if mandatory dosage markings have to be included in the closure. Having to integrate dosage markings in the bottle closures will require manufacturers to increase the size of the bottle lids, therefore going against the objective of packaging minimization as described in Article 9, point 1 of PPWR.
• Continuous efforts to further compact detergents mean the required dosing for the detergent will change the more highly concentrated the product becomes. The dosing markings in the closure will have to change with each new product innovation, adding tremendous cost and complexity for industry since new closure molds would be required with every product innovation.
• In order to reduce complexities, manufacturers use one closure mold for multiple products. The requirements from the Parliament would force industry to go back to individual molds for each separate product, increasing waste in the supply chain and going against the provisions indicated in Article 9, point 2a of PPWR, which aim to standardize the format of packaging.
• Phosphorus
The industry supports the Council’s and Commission’s proposals, which maintain the currently existing phosphorus limits and do not restrict the phosphorus content further.

A.I.S.E. evaluates that the currently existing limits on phosphorus content for consumer laundry detergents & consumer automatic dishwasher detergents are sufficient. However, the industry understands the Parliament's ambition to limit the use of phosphorus. Furthermore, we are aware that a possible agreement will need to be found during the Trilogues to address the EP's concerns about this topic.
Should the policymakers consider it necessary to introduce further phosphorus limits as part of the trilogues negotiations, the new alternative limits must address only consumer laundry detergents and consumer automatic dishwasher detergents.
However, we strongly recommend not extending any new limits to industrial and institutional (I&I) cleaning products given that:
• In the absence of legislative intervention, I&I sector has already replaced phosphates where technically feasible, reducing by 18% the release of phosphorous substances in Europe from 2014 to 2020 according to A.I.S.E. internal survey.
• The use of phosphorous substances is critical for a variety of industries and applications especially in the absence of suitable alternatives.
• I&I sector contributes circa 0.7 to 1.6% of the total P total inputs to surface waters according to a published UBA report2. It states possible phosphorus restriction in I&I detergents is not expected to lead to a measurable change in surface water quality.
• Furthermore, having lower limits for I&I products could lead to adverse social consequences which are not impact assessed. Should these products not perform correctly, the proper and necessary cleaning in hospitals would not be performed, risking not having the level of hygiene required and necessary in hospitals.

• Intentionally added ingredients
The Council proposes in recital 6 (line 15) to remove the word “intentionally” from the text, when referring to (chemical) ingredients and to microorganisms. It is mentioned that the word “added” should cover all ingredients that are added by an actor in the manufacturing chain and that impurities should not be considered as “added.”
Our industry recommends keeping the wording as initially proposed by the Commission and not to delete the word “intentionally” from the text. Keeping the wording “intentionally” will:
• Bring legal certainty concerning the provisions that are applicable and to which substances
The explanation from the Council is present in a recital, which is less legally binding than articles. The explanation present in recital 6 could therefore still be questioned or even ignored by stakeholders, and we expect that stakeholders might have different interpretations of some articles due to this fact. Removing the word “intentionally” will therefore bring unclarity and misalignment in the interpretation of some articles.

• Correspond to an enforceable system for the manufacturers, as the requirements should only cover intentionally added ingredients and not impurities.
Depending on the interpretation that stakeholders will make of the articles, we expect that some of them might understand the text as if the requirements should be applicable to ingredients, but also to carry-over and even potentially to impurities. Should the scope be extended due to this enlarged interpretation, it will have huge consequences for the industry, as minor changes in the composition (due to impurities for example) will have to be monitored and managed. This will require extensive adaptations in the production processes and will have huge costs implications.

• Ensure alignment with the phrasing already used by other pieces of legislation
The phrasing “intentionally added” is already used and recognized in many other pieces of legislation, such as the Cosmetic Products Regulation. Keeping the same wording in the Detergents Regulation will ensure legal coherence with other legislations and ensure that the same interpretation of the requirements is made across legislations.

Detergentide määruse triloog.asice

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HALLAR MEYBAUM PNOEE-35508080232 2025-04-29 10:35:00

Detergentide määruse triloog.pdf

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+372 613 9775 [email protected] www.keemia.ee

Pr. Karmen Joller Sotsiaalminister Meie 29.04.25 Sotsiaalministeerium Edastatud e-postiga: [email protected] [email protected] Pr. Mari-Anne Härma peadirektori asetäitja Terviseamet Edastatud e-postiga: [email protected] [email protected] Detergentide määruse läbivaatamine (triloog) Mõistame, et 24. aprillil toimunud Tehnilise Ühtlustamise Töögrupi (Technical Harmonisation WP) kohtumisel vahetasid liikmesriigid mõtteid Euroopa Komisjoni uue detergentide eelnõu üle ning käsitleti biolagunevuse nõudeid, koostisainete andmelehti, mikroorganisme ning mõningaid täiendavaid teemasid. Mitmed teemad (nt biolagunevus) on meie liikmete jaoks võtmetähtsusega ning praegu arutlusel olevad sätted avaldavad olulist mõju tööstuse tulevikule. Seetõttu oleksime väga tänulikud, kui võtaksite arvesse meie käesolevale e-kirjale lisatud sisendi ja soovitused. Saame aru, et liikmesriikidele on jäetud pisut aega kirjalike seisukohtade esitamiseks. Täpsemalt:

 Biolagunevus: Soovitame toetada Komisjoni kompromiss-ettepanekut biolagunevuse nõuete kohta ning esitatud määratlust „kilepolümeeride“ kohta. Tööstus toetab täielikult Komisjoni ettepanekut hinnata vajadust biolagunevuse kriteeriumide kehtestamiseks teadusandmete alusel, vältides samas meelevaldseid tähtaegu volitusaktide vastuvõtmiseks. Jagame Komisjoni muret, et biolagunevuse hindamiseks tuleb kilepolümeeride puhul esmalt katsemeetodeid kohandada ja edasi arendada. Lisaks ei ole muude orgaaniliste ainete osas läbi viidud mõjuhinnangut ega teaduslikku analüüsi, mis määraks, millised ained kuuluvad ettepaneku reguleerimisalasse.

Lisaks toetame uut ettepanekut kilepolümeeride määratluse kohta: (12a) ‘Film polymers’ means polymers used in water-soluble films to encapsulate detergents;

 Koostisosade andmelehed: Tööstus toetab Euroopa Komisjoni viimast ettepanekut, mis näeb ette uurida, kuidas saaks tulevikus lihtsustada koostisosade andmelehe (IDS)

edastamist mitteohtlike pesuvahendite puhul. Tegemist on keerulise küsimusega, mis vajab analüüsi ning eelnevalt ei tohiks IDS-i edastamist siduda digitaalse tootepassiga – see tekitab ebavajalikku administratiivset koormust ettevõtetele ja ka täiendavat segadust meditsiinipersonalile.

 Mikroorganismid: Toetame Komisjoni poolt valitud suunda uues kompromissettepanekus, mis lähtub Nõukogu volitusest ja näeb ette mikroorganismide kasutamise riskihindamise puhastusvahendites.

 Doseerimine: Oleme vastu Euroopa Parlamendi mandaadi punktidele, mis puudutavad doseerimisseadmete ja mõõtetopside värvi- ja kontrastmärgistusi ning on endiselt arutlusel. Kohustuslike doseerimismärgistuste kehtestamine pudelikorkides (nagu on ette nähtud Euroopa Parlamendi rea 514a ettepanekus) on vastupidine samm tööstuse ja regulatiivsete asutuste ühistele eesmärkidele – nimelt pakendijäätmete vähendamisele, taaskasutamise suurendamisele ja ringlussevõetud materjalide kasutuselevõtule. Lisaks suurendab see oluliselt administratiivseid ja muid kulusid.

 Fosfor: toetame Euroopa Nõukogu ja Euroopa Komisjoni ettepanekuid, millega säilitatakse kehtivad fosforisisalduse piirnormid ega kehtestata täiendavaid piiranguid. Meie hinnangul on praegused fosforipiirangud tarbijatele mõeldud pesupesemisvahendites ja automaatsetes nõudepesuvahendites piisavad. Samas mõistame Euroopa Parlamendi kõrgendatud ambitsiooni fosfori kasutust piirata ning oleme teadlikud, et triloogi läbirääkimistel tuleb tõenäoliselt leida kompromiss, mis arvestab Parlamendi muresid. Juhul, kui peetakse vajalikuks kehtestada täiendavad fosforipiirangud, rõhutame, et need peaksid olema suunatud üksnes tarbijatele mõeldud pesupesemisvahenditele ja automaatsetele nõudepesuvahenditele. Seejuures juhime tähelepanu, et fosfori sisalduse võimalik täiendav piiramine tarbijate pesuvahendites võib avaldada negatiivset mõju järgmistes valdkondades:

 Toote toimivus: Fosfor aitab stabiliseerida vee kareduse ja vältida katlakivi teket. Fosfori vähendamine võib vähendada pesuvahendite efektiivsust, suurendades vajadust suuremate pesuainekoguste ja korduvpesu järele.

 Vee- ja energiatarbimine: Vähem tõhusad pesuvahendid võivad viia korduvpesu vajaduseni, suurendades oluliselt vee- ja energiatarbimist, tõstes seeläbi kodumajapidamiste kulusid ja keskkonnakoormust.

 Seadmete hooldus: Katlakivi suurenemine seadmetes nagu pesumasinad ja nõudepesumasinad võib lühendada seadmete eluiga ja tõsta hoolduskulusid.

 Alternatiivsete koostisosade mõju: Fosfori asendamine näiteks sidrunhappega võib nõuda kõrgemaid pesutemperatuure ja suuremaid kemikaalikoguseid, mis omakorda suurendab keskkonnamõju ja pakendijäätmeid.

Lisaks tuleb arvestada, et fosfori alternatiivide arendamine toob tootjate jaoks kaasa märkimisväärseid teadus- ja arenduskulusid ning nõuab pikki üleminekuperioode uute keemiliste ühendite ja nende baasil toodetud puhastusvahendite turule toomiseks. Tööstuslike ja institutsionaalsete (I&I) puhastustoodete osas soovitame tungivalt mitte kehtestada täiendavaid piiranguid, arvestades järgmisi tegureid:

o Mõjuhinnangute puudumine;

o Professionaalse sektori poolt tekitatud fosforikoormuse väga madal osakaal (umbes 0,7–1,6% pinnavette sattuvast kogusest, vastavalt UBA aruandele);

o Sobivate alternatiivide puudumine, mis suudaksid tagada sama efektiivsuse;

o Hügieenistandardite tagamise kriitiline vajadus sektorites nagu tervishoid ja toiduainetetööstus.

Fosforipõhised ühendid on hädavajalikud optimaalse puhastustulemuse ja hügieenistandardite saavutamiseks, eriti professionaalses kasutuses, sealhulgas farmaatsias, tervishoius, toidu- ja joogitööstuses, põllumajanduses, professionaalsetes köökides, hoonete hoolduses ja tööstuslikus pesupesemises. Kokkuvõttes toetame seniste fosforipiirangute säilitamist, mõistlikku ja teaduspõhist lähenemist võimalike täiendavate piirangute kaalumisel ning vajadust kaitsta nii keskkonda kui ka ühiskonna tervist ja tööstuslikku konkurentsivõimet.

 Tahtlikult lisatud ained : Nõukogu teeb retsitaalis 6 (rida 15) ettepaneku eemaldada

tekstist sõna „tahtlikult“, kui viidatakse (keemiliste) koostisosade ja mikroorganismide lisamisele. Palume säilitada Komisjoni algselt ette pandud sõnastuse ning mitte eemaldada tekstist sõna „tahtlikult“ – see tagab paremini õiguskindluse ning kooskõla muudes õigusaktides juba kasutusel oleva sõnastusega.

 Lisaks digitaalne tootepass, DPP (kuigi see ei ole otseselt viimase töögrupi teema) : Meil on tõsine mure, kuidas VKE-d tulevad toime DPP rakendamisega. Üleminekuperioodid peavad olema võimalikult pikad (36 või 48 kuud) ja algama alles siis, kui kõik vajalikud rakendusaktid nii detergentide määruse kui ka ökodisaini määruse alusel on vastu võetud.

Toetame DPP alusena mudeli kontseptsiooni, mis on seotud V lisa koostisosade loeteluga. Leiame, et Komisjoni kompromiss-ettepanek, mis jagab DPPs esitatava teabe kohustuslikuks ja vabatahtlikuks, võib olla sobiv lahendus.

Manusest leiab lisaks ka meie katusorganisatsiooni A.I.S.E seisukohad samade teemade osas. Täname Teid ette lahke kaalumise eest. Lugupidamisega /allkirkastud digitaalselt/ Hallar Meybaum tegevdirektor Kärt Alaküla Kemikaali- ja arendusnõunik 6139775; [email protected]

E-kiri.eml

Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.
Tundmatu saatja korral palume linke ja faile mitte avada.

Tere!

Austatud Karmen Joller ja Mari-Anne Härma

Hetkel toimuvale detergentide määruse läbivaatamise triloogiale edastame erinevate arutusel olevate teemade kohta oma seisukohad.

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