NOTA INFORMATIVA SOBRE COFORMULANTES INACEPTABLES EN PRODUCTOS FITOSANITARIOS
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SECRETARIA DE ESTADO
DE SANIDAD
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SALUD PÚBLICA
SUBDIRECCIÓN GENERAL
DE SANIDAD AMBIENTAL Y
SALUD LABORAL
Rev.1 – October 2018 (Rev.2 – September 2021)
NOTA INFORMATIVA SOBRE COFORMULANTES INACEPTABLES EN PRODUCTOS
FITOSANITARIOS
En relación con los coformulantes inaceptables en los productos fitosanitarios, el Reglamento (CE) nº
1107/2009 recoge en el artículo 27 que no se aceptará la inclusión en los productos fitosanitarios de
coformulantes si sus residuos, resultantes de una aplicación conforme a las buenas prácticas fitosanitarias
y en condiciones realistas de uso, tienen efectos nocivos en la salud humana o animal o en las aguas
subterráneas o efectos inaceptables en el medio ambiente. Tampoco puede aceptarse la inclusión en los
productos fitosanitarios de coformulantes si su utilización, resultante de una aplicación conforme a las
buenas prácticas fitosanitarias y en condiciones realistas de uso, tiene efectos nocivos en la salud humana
o animal o efectos inaceptables en los vegetales, los productos vegetales o el medio ambiente. Estos
coformulantes inaceptables deben figurar en el Anexo III del Reglamento (CE) nº 1107/2009. Se da la
circunstancia que hasta el 4 de marzo de 2021 no se habían establecido normas europeas respecto a este
tema y cada Estado miembro aplicaba los criterios nacionales.
El Reglamento (UE) 2021/383 de la Comisión de 3 de marzo de 2021, por el que se modifica el Anexo
III del Reglamento (CE) nº 1107/2009 del Parlamento Europeo y del Consejo, detalla una lista de los
coformulantes que no pueden entrar en la composición de los productos fitosanitarios (C/2021/1359 DO
L 74) y ha sido publicado en el Diario Oficial de la Unión Europea el 4.3.2021. La lista incluye
coformulantes que tienen asignada una clasificación armonizada como carcinógenos de categoría 1A o1B,
como mutágenos de categoría 1A o 1B, o como tóxicos para la reproducción de categoría 1A o 1B, de
conformidad con el anexo VI del Reglamento (CE) nº 1272/2008, los considerados PBT o mPmB, de
conformidad con el artículo 57, letras d) y e), del Reglamento (CE) nº 1907/2006, los considerados
sustancias altamente preocupantes debido a sus propiedades de alteración endocrina de conformidad
con el artículo 57, letra f), del Reglamento (CE) nº 1907/2006, y los considerados COP en virtud del
Reglamento (UE) 2019/1021. Las tallowaminas polietoxiladas, el PHMB (1600; 1,8) y el PHMB (1415; 4,7)
también están incluidos en la lista del anexo III.
La publicación de este Reglamento ha sido una primera aproximación de cara a la completa
armonización de los coformulantes inaceptables. El listado es abierto y, tal y como se recoge en el
apartado 3 del artículo 27 del Reglamento (CE) nº 1107/2009, podrá ser revisado en cualquier momento
por la Comisión teniendo en cuenta la información pertinente facilitada por los Estados miembros.
Otros coformulantes (es decir, aquellos inaceptables en algunos productos y/o en ciertas
condiciones) pueden seguir siendo restringidos a nivel nacional. Esto queda recogido en el informe de la
Comisión (Summary report) de diciembre de 2018, publicado en la página web de la DG-SANTE
https://ec.europa.eu/food/system/files/2019-02/sc_phyto_20181212_ppl_sum.pdf.
Según la Comisión, los procedimientos para la futura identificación de coformulantes inaceptables
basados en el riesgo podrían detallarse en un Reglamento de aplicación por el que se establezcan normas
para identificarlos.
Hasta la fecha de la entrada en vigor del Reglamento (UE) 2021/383, cada Estado miembro tenía sus
propios criterios nacionales en base a las disposiciones transitorias. Es por ello que, en ausencia de un
listado comunitario (Anexo III) y en aplicación de la disposición transitoria del Reglamento, a nivel
nacional se ha venido publicando en la página web del Ministerio, desde hace más de una década, un
listado de coformulantes inaceptables en los productos fitosanitarios cuya última revisión fue en octubre
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de 2018 “Coformulants unacceptable for inclusion in plant protection products in Spain. Rev.1 – October
2018”.
Se ha comprobado que la mayoría de los coformulantes incluidos en el listado del Anexo III se
encontraban recogidos en el documento de criterios nacionales de coformulantes inaceptables. No
obstante, se cree conveniente hacer una mención especial a los agentes liberadores de formaldehído
dado que en el Anexo III se incluye la sustancia Formaldehído (CAS 50-00-0). Por ello, las sustancias que se
comporten como agentes liberadores de formaldehído tendrán la misma consideración, en tanto que
producen o liberan formaldehído.
Un listado detallado de los agentes liberadores de formaldehído puede encontrarse en los siguientes
documentos de la ECHA:
https://echa.europa.eu/documents/10162/13641/bd_call_for_evidence_fa_and_releasers_request_en.pdf
https://echa.europa.eu/documents/10162/8ee35676-a94c-53b0-1e89-b2aef767bdd2
Con la entrada en vigor el Reglamento (UE) 2021/383, los coformulantes inaceptables recogidos en
el Anexo III deben ser eliminados del listado nacional. Para mantener un nivel elevado de protección de la
salud humana se considera que los coformulantes que figuraban en el listado de criterios nacionales y no
están incluidos en el Anexo III deben seguir siendo inaceptables debido a que están clasificados con
ciertas categorías de peligro que presentan efectos nocivos para la salud, y a que, al no ser
imprescindibles en la formulación, pueden ser sustituidos por otros coformulantes que presenten menor
riesgo. Por ello, consideramos que no deben formar parte de los productos fitosanitarios que se autoricen
a nivel nacional.
De todo lo expuesto, se deduce la necesidad de actualizar el documento de criterios nacionales de
coformulantes inaceptables y publicar la presente Nota informativa que sustituye a las publicadas con
anterioridad, la de octubre de 2018 y la Rev.1, de 29 de junio de 2021. Con ello se pretende dar a conocer
aquellos coformulantes peligrosos que se han ido encontrando en las composiciones de formulaciones
solicitadas en España y que han sido sustituidos por otros que presentan menor riesgo.
Cabe señalar que la publicación de esta Nota no añade nuevas restricciones a las ya establecidas
hace más de una década y publicadas en la web de este Ministerio cuya última revisión fue de octubre
de 2018.
A continuación, se incluye el documento de criterios nacionales de coformulantes inaceptables
actualizado, tras eliminar del listado nacional los coformulantes inaceptables recogidos en el Reglamento
(UE) 2021/383 de la Comisión de 3 de marzo de 2021.
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CO-FORMULANTS UNACCEPTABLE FOR INCLUSION IN PLANT PROTECTION
PRODUCTS IN SPAIN
Rev.1 – October 2018” (Rev.2 – September 2021)
The purpose of the Regulation (EC) No 1107/2009 of the European Parliament and of the Council of
21 October concerning the placing of plant protection products on the market and repealing Council
Directives 79/117 EEC and 91/414/EEC, is to increase the free movement of such products and the
availability of these products in the Member States (MS), taking into account the general principles of
protection of human and animal health and the environment.
In order to remove, as far as possible, obstacles to trade in existing Plant Protection Products (PPP)
due to the different levels of protection in the Member states, the mentioned Regulation lays down
harmonised rules for the approval of active substances, safeners and synergists included in PPP, and
also rules for adjuvants and co-formulants. The principle of mutual recognition is one of the means of
ensuring the free movement of goods within the Community.
Thus, the above mentioned Regulation includes requirements and conditions for approval co-
formulants. Besides, Annex III provides a list of co-formulants which are not accepted for inclusion in
PPP as referred to in Article 27. Besides, MS shall inform the other MS and the Commission where it
considers that a co-formulant has been considered unacceptable and will propose the withdrawal or the
inclusion with amended conditions.
In this context, as a general rule since 1992 in Spain the co-formulants substances classified as
Carcinogens, Mutagens or substances toxic to Reproduction (C/M/R) are not accepted for inclusion in
PPP. Neither are they accepted substances which have proved to show other chronic effects or
neurotoxicity (see Table 1). It has to be noted that Table 1 includes unacceptable co-formulants
usually found over the years in PPP formulations.
Therefore, in Spain, co-formulants (oil derived substances, diatomaceous earth, kaolinite, talc,
clays…) containing impurities with toxicological relevance such as benzene, 1,3-butadiene, polycyclic
aromatics, benzo(a)-pyrene, crystalline silica or asbestiform fibres are controlled. Besides, co-
formulants containing other components of concern such as naphthalene or toluene are also controlled.
The same rule is applied to adyuvants.
Consequently, when one of these co-formulants or adyuvants is going to be used in PPP, the impurity
certificate or the product containing components of concern is required to demonstrate that it doesn’t
contain impurities with toxicological relevance or specific components of concern and if not, the co-
formulant must be replaced by another with less risk.
Furthermore, co-formulants (commercial samples such as palygorskite (attapulgite), sepiolite and
wollastonite) containing fibres of concern are controlled according to the length of their fibres.
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Table 1: List of co-formulants unacceptable at national level for inclusion in PPP, additionally to those contented in
Annex III of Regulation (EC) nº 1107/2009
Concentration limits following
Co-formulant CAS No. Classification Reference
Regulation (EC) No 1272/2008
Regulation (EC)
1,1,2-trichloroethane 79-00-5 Carc. 2; H351 Carc. 2; H351: C ≥ 1%
No 1272/2008
Available studies
2-pyrrolidone 616-45-5 Repr.2; H361d Repr.2; H361d: C ≥ 3%
at national level
Carc. 2; H351: C ≥ 1%
Carc. 2; H351
Regulation (EC) Muta 2; H341: C ≥ 1%
Aniline 62-53-3 Muta 2; H341
No 1272/2008 (*) STOT RE 1; H372: C ≥ 1%
STOT RE 1; H372
(*) STOT RE 2; H373: 0.2% ≤ C < 1%
Pentasodium Repr.2; H361d Regulation (EC) Repr. 1B; H360D: C ≥ 0.3%
(carboxylatomethyl)iminobis 140-01-2 STOT RE 2; H373 No 1272/2008 STOT RE 2; H373 (inhalation):
(ethylenenitrilo)tetraacetate (inhalation) C ≥ 10%
Dichloromethane; 75-09-2 Regulation (EC)
Carc. 2; H351 Carc. 2; H351: C ≥ 1%
methylene chloride No 1272/2008
Diethylene glycol
111-77-3 Regulation (EC)
monomethyl ether; Repr.2; H361d Repr.2; H361d: C ≥ 3%
No 1272/2008
2-(2-methoxyethoxy)- ethanol
Diethyl Phthalate;
84-66-2
1,2-benzenedicarboxylic acid, Repr.2; H361d Literature search Repr.2; H361d: C ≥ 3%
diethyl ester
Isophorone;
Regulation (EC)
3,5,5-trimethylcyclohex-2- 78-59-1 Carc. 2; H351 Carc. 2; H351: C ≥ 1%
No 1272/2008
enone
Methanol; Regulation (EC) (*) STOT SE 1; H370: C ≥ 10%
67-56-1 STOT SE 1; H370
methyl alcohol No 1272/2008 (*) STOT SE 2; H371: 3% ≤ C < 10%
Regulation (EC)
Naphthalene 91-20-3 Carc. 2; H351 Carc. 2; H351: C ≥ 1%
No 1272/2008
Repr. 2; H361f Regulation (EC) Repr. 2; H361f: C ≥ 3%
N-hexane 110-54-3
STOT RE 2; H373 No 1272/2008 (*) STOT RE 2; H373: C ≥ 5%
Repr. 2; H361d Regulation (EC) Repr. 2; H361d: C ≥ 3%
Toluene 108-88-3
STOT RE 2; H373 No 1272/2008 STOT RE 2; H373: C ≥ 10%
Regulation (EC)
Tributyl phosphate 126-73-8 Carc. 2; H351 Carc. 2; H351: C ≥ 1%
No 1272/2008
(*) Specific concentration limits for the substance under consideration in Annex VI of Regulation (EC) 1272/2008
Control of impurities or components with toxicological relevance in co-formulants used in the
preparation of PPP
Impurities with toxicological relevance in Oil derived substances
In Spain, oil derived co-formulants containing impurities with toxicological relevance, such as
benzene, 1,3-butadiene, benzo[a]-pyrene and DMSO extract, are controlled according to the notes
related to the identification, classification and labelling of certain complex oil-derived substances in
Annex VI Part 3 of the Regulation (EC) No 1272/2008 (see table 2).
Consequently, when one of these oil derived substances is going to be used in PPP, an impurity
certificate is required to ensure that the amount of impurity is below the level allowed in this co-
formulant. When the amount of impurity is above the level allowed, the co-formulant must be replaced
by another with less risk.
The Regulation (EC) No 1272/2008 of 16 December 2008 on classification, labelling and packaging
of substances and mixtures, contains the classification of complex oil derived substances, which are
very often used in the preparation of PPP. These substances have specific effects on human health and
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are classified as carcinogenic or mutagenic unless specific impurities are below certain levels in these
substances.
The following notes relating to the identification, classification and labelling apply only to certain
complex oil-derived substances in Annex VI Part 3 of the Regulation (EC) No 1272/2008:
Note J:
The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the
substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7), in which case a classification
in accordance with Title II of this Regulation shall be performed also for those hazard classes
Note K:
The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the
substance contains less than 0,1 % w/w 1,3- butadiene (Einecs No 203-450-8), in which case a
classification in accordance with Title II of this Regulation shall be performed also for those hazard
classes. Where the substance is not classified as a carcinogen or mutagen, at least the precautionary
statements (P102-) P210-P403 shall apply
Note L:
The harmonised classification as a carcinogen applies unless it can be shown that the substance
contains less than 3 % of dimethyl sulphoxide extract as measured by IP 346 (“Determination of
polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions –
Dimethyl sulphoxide extraction refractive index method” Institute of Petroleum, London), in which
case a classification in accordance with Title II of this Regulation shall be performed also for that
hazard class.
Note M:
The harmonised classification as a carcinogen applies unless it can be shown that the substance
contains less than 0,005 % w/w benzo[a]-pyrene (Einecs No 200-028-5), in which case a classification
in accordance with Title II of this Regulation shall be performed also for that hazard class.
Note P:
The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the
substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7), in which case a classification
in accordance with Title II of this Regulation shall be performed also for those hazard classes. Where
the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-
) P260-P262-P301 + P310-P331 shall apply.
Components of concern in Oil derived substances
In oil-derived co-formulants used in the preparation of PPP, some components of concern, such as
naphthalene (classified as Carc. 2 in the regulation (EC) No 1272/2008) and toluene (Toluene is
classified as Repr. 2 in the Regulation (EC) No 1272/2008), are often present.
If one of these oil derived substances is going to be used in PPP, in Spain the amount of naphthalene
or toluene in the co-formulant is controlled (see table 2). Consequently, oil-derived co-formulants with
a content above the concentration limits laid down in CLP Regulation (EC) No 1272/2008 (1% of
naphthalene or 3% of toluene) leading to its classification as carcinogenic or toxic to reproduction
respectively, are not allowed.
A certificate with the content of naphthalene or toluene is required to ensure that the amount is below
the level allowed in the co-formulant. When the content is above the level allowed, the co-formulant
must be replaced by another with less risk.
Content of crystalline silica in Quartz sand, kieselgur, aluminium silicate and other mineral and clays
used in PPP containing dust
These substances could be classified as carcinogenic depending on the content of respirable crystalline
silica in the form of quartz or cristoballite. According to the IARC [IARC Monographs Volume 68
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(1997) and Volume 100C (2012)], respirable crystalline silica in the form of quartz or cristoballite
causes cancer of the lung in humans and it is carcinogenic in humans (Group 1). In application of
Regulation (EC) No 1272/2008, if respirable crystalline silica is present in the mixture as an ingredient
at a concentration ≥ 0.1 % the product should be classified as carcinogen with the category 1A and the
hazard statement “H350i: May cause cancer by inhalation”.
The Spanish Authority considers that, taking into account the whole available data in the IARC
documents and other scientific literature, this respirable fraction is the one of special concern for the
carcinogenicity of crystalline silica in the form of quartz or cristobalite.
Consequently, if one of these co-formulants is going to be used in PPP containing dust, in Spain the
amount of respirable crystalline silica in the form of quartz or cristobalite is controlled (see Table 2).
Table 2: List of co-formulants, which can contain impurities with toxicological relevance or components of concern
Concentration limits
Requirements for
Co-formulant Classification following Regulation (EC) No
national registration
1272/2008
Concentration in oil derived
An impurity certificate Some of these substances are substances of the following
is required to ensure classified as carcinogenic or impurities equal or exceeding
that the amount of mutagenic in the Regulation these limits is not allowed:*
impurity is below the (EC) No 1272/2008 unless 0.1% w/w benzene
level allowed in this co- specific impurities are below 0.1% w/w 1,3-butadiene
formulant. certain levels 3.0% w/w DMSO extract
0.005% w/w benzo [a]-pyrene
Some of these substances could
be classified as carcinogenic Concentration ≥ 1% w/w of
Oil derived substances
Certificate with the depending on the content of naphthalene leading these co-
content of naphthalene Naphthalene (classified as Carc. formulants to be regarded as
2 in the Regulation No (EC) Carc.2 is not allowed.
1272/2008)
Some of these substances could
Concentration ≥ 3% w/w of
be classified as toxic to
toluene leads these co-
Certificate with the reproduction depending on the
formulants to be regarded as
content of toluene content of Toluene (classified
Repr.2 is not allowed.
as Repr. 2 in the Regulation No
(EC) 1272/2008)
Quartz sand (CAS:
14808-60-7; Quartz,
Silicium dioxide, Silica,
Silicon dioxide, SiO2)
Kieselgur (CAS: 61790-
53-2; diatomaceous
earth)
Aluminium silicate Certificate with the total Concentration ≥ 0.1% w/w of
This substance could be
(CAS: 1332-58-7; content of crystalline respirable crystalline silica in
classified as carcinogenic
Kaolin) silica (in the form of the form of quartz or
depending on the content of
Smectite group quartz or cristobalite) cristobalite leading these co-
crystalline silica (considered as
minerals (CAS 12199- and the content of the formulants to be regarded as
carcinogenic to humans Group
37-0); bentonite (CAS respirable fraction of possible Carc. 1A is not
1 by IARC)
1302-78-9); crystalline silica. allowed.
montmorillonite (CAS
1318-93-0); sepiolite
(CAS 63800-37-3);
pumice (CAS 1332-09-
8), talc (CAS 14807-96-
6) and attapulgite (CAS
12174-11-7)
* Concentration limits of impurities established according to notes related to the identification, classification and labelling applying only to
certain complex oil-derived substances (Regulation (EC) No 1272/2008).
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Co-formulants, which can contain fibres of concern
Attapulgite in PPP containing dust
The International Agency for Research on Cancer (IARC) has ruled Attapulgite fibres > 5 µm as
possibly carcinogenic to humans (Group 2B).
Attapulgite with fibres > 5 µm is not allowed to be used in PPP containing dust in Spain (Table 3). A
certificate with the content and length of the fibres is required.
Talc
The International Agency for Research on Cancer (IARC) has ruled that talc containing asbestiform
fibres is carcinogenic to humans (Group 1).
Talc containing asbestiform fibres is not allowed to be use in PPP in Spain (Table 3). A certificate of
absence of asbestiform fibres is required.
Table 3: List of co-formulants, which can contain fibres of concern whose length is being controlled
Requirements for
Co-formulant Classification Concentration limits
national registration
Attapulgite with long fibres (>
Certificate with the
Attapulgite 5 µm) is possibly carcinogenic
content and length of the Absence of fibres > 5 µm
(CAS 12174-11-7) (1) to humans (considered Group
fibres
2B by IARC)
Talc with asbestiform fibres is
Talc Certificate of absence of Absence of asbestiform
considered as carcinogenic to
(CAS 14807-96-6) asbestiform fibres(1) fibres
humans Group 1 by IARC
(1) See Table 2 for other requirements
This document can be updated based on the evolution of scientific knowledge and European Union
legislation
Madrid, 13 de septiembre 2021
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