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Commission Regulation (EU) No 547/2011

of 8 June 2011

implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC(1), and in particular Article 65(1) thereof,

Whereas:

(1) In accordance with Regulation (EC) No 1107/2009 the labelling requirements set out in Article 16 of Directive 91/414/EEC of the Council of 15 July 1991 concerning the placing of plant protection products on the market(2) and in Annexes IV and V thereto, are to continue to apply under Regulation (EC) No 1107/2009.

(2) It is therefore necessary for the implementation of Regulation (EC) No 1107/2009 to adopt a regulation incorporating those labelling requirements for plant protection products with any necessary modifications, such as updating references.

(3) Provisions should be included concerning re-use of packaging and concerning plant protection products which are to be used for experiments or tests for research or development purposes.

(4) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

[F1Article A1U.K.Interpretation

1.Paragraph 2 applies where Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances applies in relation to an application by virtue of—

(a)Article 1 of that Regulation, or

(b)Article A1(2) of Commission Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances.

2.Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 544/2011, or a specified part of Commission Regulation (EU) No 544/2011, is to be read in relation to the application as a reference to Commission Regulation (EU) No 283/2013, or the equivalent part of Commission Regulation (EU) No 283/2013 (as the case may be).

3.Paragraph 4 applies where Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products applies in relation to an application by virtue of—

(a)Article 1 of that Regulation, or

(b)Article A1(2) of Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products.

4.Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 545/2011, or a specified part of Commission Regulation (EU) No 545/2011, is to be read in relation to the application as a reference to Commission Regulation (EU) No 284/2013, or the equivalent part of Commission Regulation (EU) No 284/2013 (as the case may be).]

Textual Amendments

Article 1U.K.

The labelling of plant protection products shall comply with the requirements, as set out in Annex I, and contain, where approriate, the standard phrases for special risks to human or animal health or to the environment, as set out in Annex II, and the standard phrases for safety precautions for the protection of human or animal health or of the environment, as set out in Annex III.

Article 2U.K.

F2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Textual Amendments

F3...

Textual Amendments

ANNEX IU.K.LABELLING REQUIREMENTS AS REFERRED TO IN ARTICLE 1

(1)The following information shall be included clearly and indelibly on the packaging of plant protection products:U.K.

(a)

the trade name or designation of the plant protection product;

(b)

the name and address of the holder of the authorisation and the authorisation number of the plant protection product and, if different, the name and address of the person responsible for the final packaging and labelling or for the final labelling of the plant protection product on the market;

(c)

the name of each active substance expressed as provided for in [F4Article 18(3) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council] with clear indication of the chemical form. The name must be as given in [F5the GB mandatory classification and labelling list] or, if not included therein, its ISO common name. If the latter is not available, the active substance shall be designated by its chemical designation according to IUPAC rules;

(d)

the concentration of each active substance expressed as follows:

(i)

for solids, aerosols, volatile liquids (maximum boiling point 50 °C) or viscous liquids (lower limit 1 Pa s at 20 °C), as % w/w and g/kg,

(ii)

for other liquids/gel formulations, as % w/w and g/l,

(iii)

for gases, as% v/v and % w/w.

Textual Amendments

If the active substance is a micro-organism, its content shall be expressed as the number of active units per volume or weight or any other matter that is relevant to the micro-organism, e.g. colony forming units per gram (cfu/g);

(e)

the net quantity of plant protection product given in: g or kg for solid formulations, g, kg, ml or l for gases and ml or l for liquid formulations;

(f)

the formulation batch number and production date;

(g)

information on first aid;

(h)

the nature of any special risks to human or animal health or to the environment, by means of standard phrases selected by the competent authority, as appropriate, from those set out in Annex II;

(i)

safety precautions for the protection of human or animal health or of the environment, in the form of standard phrases selected by the competent authority, as appropriate, from those set out in Annex III;

(j)

the type of action of the plant protection product (e.g. insecticide, growth regulator, herbicide, fungicide, etc.) and the mode of action;

(k)

the type of preparation (e.g. wettable powder, emulsifiable concentrate, etc.);

(l)

the uses for which the plant protection product has been authorised and any specific agricultural, plant health and environmental conditions under which the product may be used or shall not be used;

(m)

directions for and conditions of use and the dose rate including where appropriate the maximum dose per hectare per application and the maximum number of applications per year. The dose rate is expressed in metric units, for each use provided for under the terms of the authorisation;

(n)

where appropriate, the safety interval for each use between the last application and:

(i)

sowing or planting of the crop to be protected,

(ii)

sowing or planting of succeeding crops,

(iii)

access by humans or animals,

(iv)

harvesting,

(v)

use or consumption;

(o)

particulars of possible phytotoxicity, varietal susceptibility, and any other direct or indirect adverse side effects on plants or products of plant origin together with the intervals to be observed between application and sowing or planting of:

  • the crop in question, or

  • subsequent and adjacent crops;

(p)

if accompanied by a leaflet, as set out in point 2, the sentence ‘Read accompanying instructions before use’;

(q)

directions for appropriate conditions of storage, safe disposal of the plant protection product and of the packaging;

(r)

where necessary, the expiry date for normal conditions of storage;

(s)

a prohibition concerning the re-use of packaging, except by the authorisation holder and on condition that packaging has been specifically designed in order to allow re-use by the authorisation holder;

(t)

any information required by the authorisation in accordance with Articles 31, 36(3), 51(5) or 54 of Regulation (EC) No 1107/2009;

(u)

the categories of users allowed to use the plant protection product, where use is limited to certain categories.

[F6(1A)In point (1)(c), the “GB mandatory classification and labelling list” means the list of mandatory classification and labelling requirements of substances and groups of substances established and maintained in accordance with Article 38A of Regulation (EC) No 1272/2008.]U.K.

Textual Amendments

(2)The information required by points 1-(m), (n), (o), (q), (r) and (t) may be indicated on a separate leaflet accompanying the package if the space available on the package is too small. Such a leaflet shall be regarded as part of the label.U.K.

(3)In no circumstances may the label of the packaging of a plant protection product bear the indications ‘non-toxic’, ‘harmless’, or similar indications. However, information that the plant protection product may be used when bees or other non target species are active, or when crops or weeds are in flower or other such phrases to protect bees, or phrases with similar information concerning the protection of bees or of other non-target species, may be included in the label, if the authorisation explicitly allows use under such conditions.U.K.

[F7(4) A competent authority may make the placing of plant protection products on the market in its constituent territory subject to the additional labelling of the product in a language other than English.]U.K.

Textual Amendments

(5)By way of derogation from point (1), labelling and packaging of plant protection products to be used for experiments or tests for research or development purposes, as provided for in Article 54 of Regulation (EC) No 1107/2009, need only comply with points (1)(b), (c), (d), (j), (k) of this Annex. The label shall include information required by the permit for trial purposes, provided for in Article 54(1) of Regulation (EC) No 1107/2009 and the words ‘product intended for experimental use, not fully characterised, handle with extreme care’.U.K.

ANNEX IIU.K.STANDARD PHRASES FOR SPECIAL RISKS TO HUMAN OR ANIMAL HEALTH OR TO THE ENVIRONMENT AS REFERRED TO IN ARTICLE 1

INTRODUCTIONU.K.

The following additional standard phrases are defined to supplement the phrases provided for by [F8Regulation (EC) No 1272/2008], which applies to plant protection products. The provisions of that [F9Regulation] shall also be used for plant protection products containing micro-organisms, including viruses, as active substances. The labelling of products containing micro-organisms, including viruses, as active substances shall also reflect the provisions concerning dermal and respiratory sensitisation testing which are laid down in part B of the Annex to Commission Regulation (EU) No 544/2011(3) and part B of the Annex to Commission Regulation (EU) No 545/2011(4).

Textual Amendments

The standard phrases for special risks are without prejudice to Annex I.

1.Standard phrases for special risksU.K.

[F101.1.1.1. Special risks related to humans (RSh)U.K.
RSh 1U.K.

— Toxic by eye contact.

RSh 2U.K.

— May cause photosensitisation.

RSh 3U.K.

— Contact with vapour causes burns to skin and eyes and contact with liquid causes freezing.]

Textual Amendments

1.2.Special risks related to the environment (RSe)U.K.

None.

2.Attribution criteria for standard phrases for special risksU.K.

2.1.Attribution criteria for standard phrases related to humansU.K.
RSh 1U.K.

Toxic by eye contact.

The phrase shall be assigned where an eye irritation test according to point 7.1.5 of part A of the Annex to Regulation (EU) No 545/2011 has resulted in overt signs of systemic toxicity (e.g. related to cholinesterase inhibition) or mortality among the animals tested, which is likely to be attributable to absorption of the active substance through the mucous membranes of the eye. The risk phrase shall also be applied if there is evidence in humans for systemic toxicity after eye contact.

Eye protection shall be specified in these cases, as outlined in the general provisions of Annex III.

RSh 2U.K.

May cause photosensitisation.

The phrase shall be assigned where there is clear evidence from experimental systems or documented human exposure that products show photosensitising effects. The phrase shall also be applied to products containing a given active substance or formulation ingredient, which shows photosensitising effects in humans if the product contains this photosensitising component at a concentration of 1 % (w/w) or higher.

Personal protective measures shall be specified in these cases, as outlined in the general provisions of Annex III.

RSh 3U.K.

Contact with vapour causes burns to skin and eyes and contact with liquid causes freezing.

The phrase shall be assigned to plant-protection products being formulated as liquefied gas, where appropriate (e.g. preparations of methyl bromide). Personal protective measures shall be specified in these cases, as outlined in the general provisions of Annex III.

This phrase shall not be used in cases where [F11hazard statement H314 in Regulation (EC) No 1272/2008 of the European Parliament and of the Council], are applied.

Textual Amendments

2.2.Attribution criteria for standard phrases related to the environmentU.K.

None.

ANNEX IIIU.K.STANDARD PHRASES FOR SAFETY PRECAUTIONS FOR THE PROTECTION OF HUMAN OR ANIMAL HEALTH OR TO THE ENVIRONMENT, AS REFERRED TO IN ARTICLE 1

INTRODUCTIONU.K.

The following additional standard phrases are defined to supplement the phrases provided for by [F12Regulation (EC) No 1272/2008], which applies to plant-protection products. The provisions of that [F13Regulation] shall also be used for plant-protection products containing micro-organisms, including viruses, as active substances. The labelling of products containing micro-organisms, including viruses, as active substances shall also reflect the provisions concerning dermal and respiratory sensitisation testing which are laid down in part B of the Annex to Regulation (EU) No 544/2011 and part B of the Annex to Regulation (EU) No 545/2011.

Textual Amendments

The standard phrases for safety precautions are without prejudice to Annex I.

[F141.General provisionsU.K.

All plant-protection products shall be labelled with the following phrase, which shall be supplemented by the text in parentheses, as appropriate:

— Do not contaminate water with the product or its container (Do not clean application equipment near surface water/Avoid contamination via drains from farmyards and roads).]

Textual Amendments

2.Specific safety precautionsU.K.

[F152.1.Safety precautions for operators (SPo)U.K.
General provisionsU.K.
1.Competent authorities may identify suitable personal protective equipment for operators and prescribe specific elements of this equipment (e.g. coveralls, apron, gloves, sturdy shoes, rubber boots, face protection, face shield, tightly fitting glasses, hat, hood or respirator of a specified type). Such supplementary safety precautions are without prejudice to the standard phrases applicable according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council.U.K.
2.Competent authorities may further identify the specific tasks which require particular protective equipment, such as mixing, loading or handling the undiluted product, applying or spraying the diluted product, handling recently treated materials like plants or soil or entering recently treated areas.U.K.
3.

Competent authorities may add specifications of engineering controls, such as:

Specific provisionsU.K.
SPo 1U.K.

— After contact with skin, first remove product with a dry cloth and then wash the skin with plenty of water.

SPo 2U.K.

— Wash all protective clothing after use.

SPo 3U.K.

— After igniting the product, do not inhale smoke and leave the treated area immediately.

SPo 4U.K.

— The container must be opened outdoors and in dry conditions.

SPo 5U.K.

— Ventilate treated areas/greenhouses thoroughly/time to be specified/until spray has dried before re-entry.

Textual Amendments

2.2.Safety precautions related to the environment (SPe)U.K.
SPe 1U.K.

— To protect groundwater/soil organisms do not apply this or any other product containing (identify active substance or class of substances, as appropriate) more than (time period or frequency to be specified).

SPe 2U.K.

— To protect groundwater/aquatic organisms do not apply to (soil type or situation to be specified) soils.

SPe 3U.K.

— To protect aquatic organisms/non-target plants/non-target arthropods/insects respect an unsprayed buffer zone of (distance to be specified) to non-agricultural land/surface water bodies.

SPe 4U.K.

— To protect aquatic organisms/non-target plants do not apply on impermeable surfaces such as asphalt, concrete, cobblestones, railway tracks and other situations with a high risk of run-off.

SPe 5U.K.

— To protect birds/wild mammals the product must be entirely incorporated in the soil; ensure that the product is also fully incorporated at the end of rows.

SPe 6U.K.

— To protect birds/wild mammals remove spillages.

SPe 7U.K.

— Do not apply during the bird breeding period.

SPe 8U.K.

— Dangerous to bees./To protect bees and other pollinating insects do not apply to crop plants when in flower./Do not use where bees are actively foraging./Remove or cover beehives during application and for (state time) after treatment./ Do not apply when flowering weeds are present./ Remove weeds before flowering./Do not apply before (state time).

2.3.2.3 Safety precautions related to good agricultural practice (SPa)U.K.
SPa 1U.K.

— To avoid the build-up of resistance do not apply this or any other product containing (identify active substance or class of substances, as appropriate) more than (number of applications or time period to be specified).

2.4.2.4 Specific safety precautions for rodenticides (SPr)U.K.
SPr 1U.K.

— The baits must be securely deposited in a way so as to minimise the risk of consumption by other animals. Secure bait blocks so that they cannot be dragged away by rodents.

SPr 2U.K.

— Treatment area must be marked during the treatment period. The danger from being poisoned (primary or secondary) by the anticoagulant and the antidote against it should be mentioned.

SPr 3U.K.

— Dead rodents must be removed from the treatment area each day during treatment. Do not place in refuse bins or on rubbish tips.]

3.Attribution criteria for standard phrases for specific safety precautionsU.K.

3.1.IntroductionU.K.

In general, plant-protection products are only authorised for those specified uses, which are acceptable on the basis of an assessment according to the uniform principles laid down in the Annex to Regulation (EU) No [Office of Publications please insert number-Commission Regulation (EU) No …/… of […] implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products].

As far as applicable, the specific safety precautions shall reflect the results of such assessments according to the uniform principles and shall be applied in particular in those cases where risk-mitigation measures are necessary to prevent unacceptable effects.

3.2.Attribution criteria for standard phrases for safety precautions for operatorsU.K.
SPo 1U.K.

After contact with skin, first remove product with a dry cloth and then wash the skin with plenty of water.

The phrase shall be assigned for plant-protection products containing ingredients which may react violently with water, such as cyanide salts or aluminium phosphide.

SPo 2U.K.

Wash all protective clothing after use.

The phrase is recommended when protective clothing is required to protect operators. It is obligatory for all plant protection products classified as T or T+.

SPo 3U.K.

After igniting the product, do not inhale smoke and leave the treated area immediately.

The phrase may be assigned to plant-protection products used for fumigation in cases where the use of a respiratory mask is not warranted.

SPo 4U.K.

The container must be opened outdoors and in dry conditions.

The phrase shall be assigned to plant-protection products containing active substances which may react violently with water or damp air, such as aluminium phosphide, or which may cause spontaneous combustion, such as (alkylenebis-) dithiocarbamates. This phrase may also be assigned to volatile products classified with R20, 23 or 26. Expert judgement must be applied in individual cases, to assess whether the properties of the preparation and the packaging are such as to cause harm to the operator.

SPo 5U.K.

Ventilate treated areas/greenhouses thoroughly/time to be specified/until spray has dried before re-entry.

The phrase may be assigned to plant-protection products used in greenhouses or other confined spaces, such as stores.

3.3.Attribution criteria for standard phrases for safety precautions for the environmentU.K.
SPe 1U.K.

To protect groundwater/soil organisms do not apply this or any other product containing (identify active substance or class of substances, as appropriate) more than (time period or frequency to be specified).

The phrase shall be assigned to plant-protection products for which an evaluation according to the uniform principles shows for one or more of the labelled uses that risk-mitigation measures are necessary to avoid accumulation in soil, effects on earthworms or other soil-dwelling organisms or soil microflora and/or contamination of groundwater.

SPe 2U.K.

To protect groundwater/effects on aquatic organisms do not apply to (soil type or situation to be specified) soils.

The phrase may be assigned as a risk-mitigation measure to avoid any potential contamination of groundwater or surface water under vulnerable conditions (e.g. associated to soil type, topography or for drained soils), if an evaluation according to the uniform principles shows for one or more of the labelled uses that risk-mitigation measures are necessary to avoid unacceptable effects.

SPe 3U.K.

To protect aquatic organisms/non-target plants/non-target arthropods/insects respect an unsprayed buffer zone of (distance to be specified) to non-agricultural land/surface water bodies.

The phrase shall be assigned to protect non-target plants, non-target arthropods and/or aquatic organisms, if an evaluation according to the uniform principles shows for one or more of the labelled uses that risk-mitigation measures are necessary to avoid unacceptable effects.

SPe 4U.K.

To protect aquatic organisms/non-target plants do not apply on impermeable surfaces such as asphalt, concrete, cobblestones, railway tracks and other situations with a high risk of run-off.

Depending on the use pattern of the plant-protection product, Member States may assign the phrase to mitigate the risk of run-off in order to protect aquatic organisms or non-target plants.

SPe 5U.K.

To protect birds/wild mammals the product must be entirely incorporated in the soil; ensure that the product is also fully incorporated at the end of rows.

The phrase shall be assigned to plant-protection products, such as granules or pellets, which must be incorporated to protect birds or wild mammals.

SPe 6U.K.

To protect birds/wild mammals remove spillages.

The phrase shall be assigned to plant-protection products, such as granules or pellets, to avoid uptake by birds or wild mammals. It is recommended for all solid formulations, which are used undiluted.

SPe 7U.K.

Do not apply during bird breeding period.

The phrase shall be assigned when an evaluation according to the uniform principles shows that for one or more of the labelled uses such a mitigation measure is necessary.

SPe 8U.K.

Dangerous to bees/To protect bees and pollinating insects do not apply to crop plants when in flower/Do not use where bees are actively foraging/Remove or cover beehives during application and for (state time) after treatment/Do not apply when flowering weeds are present/Remove weeds before flowering/Do not apply before (state time)

The phrase shall be assigned to plant-protection products for which an evaluation according to the uniform principles shows for one or more of the labelled uses that risk-mitigation measures must be applied to protect bees or other pollinating insects. Depending on the use pattern of the plant-protection product, and other relevant national regulatory provisions, Member States may select the appropriate phrasing to mitigate the risk to bees and other pollinating insects and their brood.

3.4.Attribution criteria for standard phrases for safety precautions for good agricultural practiceU.K.
SPa 1U.K.

To avoid the build-up of resistance do not apply this or any other product containing (identify active substance or class of substances, as appropriate) more than (number of applications or time period to be specified).

The phrase shall be assigned when such a restriction appears necessary to limit the risk of development of resistance.

3.5.Attribution criteria for standard phrases for specific safety precautions for rodenticidesU.K.
SPr 1U.K.

The baits must be securely deposited in a way so as to minimise the risk of consumption by other animals. Secure bait blocks so that they cannot be dragged away by rodents.

To ensure compliance of operators the phrase shall appear prominently on the label, so that misuse is excluded as far as possible.

SPr 2U.K.

Treatment area must be marked during the treatment period. The danger from being poisoned (primary or secondary) by the anticoagulant and the antidote against it shall be mentioned.

The phrase shall appear prominently on the label, so that accidental poisoning is excluded as far as possible.

SPr 3U.K.

Dead rodents must be removed from the treatment area each day during treatment. Do not place in refuse bins or on rubbish tips.

To avoid secondary poisoning of animals the phrase shall be assigned to all rodenticides containing anticoagulants as active substances.

(3)

See page 1 of this Official Journal.

(4)

See page 67 of this Official Journal.